E2B Generation Data Mapping

Learn how Vault Safety generates E2B(R2) and E2B(R3) files submittable to regulatory authorities.

When you export a Case to an E2B file, either for an outbound Transmission or directly from the Case page, Vault Safety maps all case data and documents to the appropriate E2B data elements.

Tip Vault Safety automatically validates E2B files. E2B Validation provides more information.

Toggle between the following tabs to learn how Vault Safety maps information to generate ICH-compliant E2B(R3) and E2B(R2) files.

ICH E2B(R3)
FDA VAERS E2B(R3)
EMA E2B(R3)
PMDA E2B(R3)
ICH E2B(R2)
FDA E2B(R2)
HC E2B(R2)

ICH E2B(R3) Mapping

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
N.1.1 Types of Message in batch	This value is always `1` for ICH ICSR.
N.1.2 Batch Number	The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	The value entered in the UID field on the Case.
N.2.r.2 Message Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

C.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier	The value from the UID field on the Case Number object.
C.1.2 Date of Creation	The date entered in the Approval Date field if the Case is Approved or Closed. If Approval Date is unavailable, the date of report generation or Transmission with a system warning. Otherwise, the date and time when the report was generated or Transmitted, calculated with full precision down to the second.
C.1.3 Type of Report	The appropriate value is populated, based on the option selected in the Report Type field on the Case: `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
C.1.4 Date Report Was First Received from Source	For initial Cases, the date entered in the Receipt Date field on the Case. For Follow-Up Cases, the date entered in the Initial Receipt Date field on the Case.
C.1.5 Date of Most Recent Information for This Report	The date entered in the New Info Date field on the Case.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?	If the Local Expedited Criteria (`case_expedited__v`) field on the Transmission (Submission or Distribution) record has a value, the system uses this value. If this field is not specified on the Transmission, the system looks at the Expedited field on the Case. If the value is Yes, this element is populated with `1` (expedited). Otherwise, this element is populated with `2` (non-expedited).

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1 Are Additional Documents Available?	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender	The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank.
C.1.6.1.r.2 Included Documents	If any documents are attached to the Case with the document type of Case > Source > Attachment, they will be encoded.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The value entered in the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case	The value entered in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case.
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value entered in the Source field on each Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.9.1.r.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment	The appropriate value is populated, based on the option selected in the Reason field on the Transmission: `1`: Nullification `2`: Amendment
C.1.11.2 Reason for Nullification/Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.1.1 Reporter's Title	The value entered in the Title field on a Reporter-type Case Contact.
C.2.r.1.2 Reporter's Given Name	The value entered in the First Name field on a Reporter-type Case Contact.
C.2.r.1.3 Reporter's Middle Name	The value entered in the Middle Name field on a Reporter-type Case Contact.
C.2.r.1.4 Reporter's Family Name	The value entered in the Last Name field on a Reporter-type Case Contact.
C.2.r.2.1 Reporter’s Organisation	The value entered in the Organization field on a Reporter-type Case Contact.
C.2.r.2.2 Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street	The value entered in the Street Name field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province	Populates the State/Province field on the Case Contact object for the primary reporter. For Domestic Cases, the system checks if the state or province is mapped to a domestic state code on a Country State/Province record. If a record exists, the Domestic State Code is exported to this field. This is useful for countries, such as Spain or Italy, where the state code is required in submissions to the EMA. If no mapping exists, the text value entered in the State/Province field is exported to this element. Contact Veeva Support to update the mapping logic, which includes for primary Reporters and non-primary Reporters on Global and Localized Cases. In 22R3 (December 2022), this enhancement will only require configuration enablement.
C.2.r.2.6 Reporter's Postcode	The value entered in the Zip/Postal Code field on a Reporter-type Case Contact.
C.2.r.2.7 Reporter's Telephone	The value entered in the Telephone field on a Reporter-type Case Contact.
C.2.r.3 Reporter’s Country Code	The ISO code populated in the Country field on a Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the E2B code of `5` is mapped.
C.2.r.5 Primary Source for Regulatory Purposes	Populated with `1` (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name	Populated Value
C.3.1 Sender Type	The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Sender Type from the Organization on the Case.
C.3.2 Sender's Organisation	The value entered in the Organisation field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Organization on the Case.
C.3.3.1 Sender's Department	The value entered in the Department field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.2 Sender's Title	The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode	The value entered in the Zip/Postal Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.8 Sender's E-mail Address	The value entered in the Email field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.
C.4.r.2 Included Documents	Any documents attached to the Case with the document type of Case > Source > Literature and the Retransmit field set to Yes are included with the transmission.

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value entered in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The values entered in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value entered in the Patient Initials / ID field on the Case.

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name	Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)	The value entered in the MRN - GP field on the Case.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)	The value entered in the MRN - Specialist field on the Case.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)	The value entered in the MRN - Hospital field on the Case.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)	The value entered in the MRN - Investigation field on the Case.

D.2 Age Information

E2B Data Element Name	Populated Value
D.2.1 Date of Birth	The date entered in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.2.2a Age at Time of Onset of Reaction / Event (number)	The value entered in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The value selected in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number)	The value entered in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit selected in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter)	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted.
D.3 Body Weight (kg)	The value entered in the Weight field on the Case.
D.4 Height (cm)	The value entered in the Height (normalized) field on the Case.
D.5 Sex	The option populated in the Gender field on the Case.
D.6 Last Menstrual Period Date	The date entered in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
D.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object.
D.7.1.r.5 Comments	The text entered in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
D.7.1.r.6 Family History	The value selected in the Family History field on the Case Medical History object.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Case, to a limit of 10,000 characters.
D.7.3 Concomitant Therapies	Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.1 Name of Drug as Reported	The value entered in the Drug (Reported) field on the Case Drug History record.
D.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History record.
D.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History record.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History record.
D.8.r.5 End Date	The value entered in the End Date field on the Case Drug History record.
D.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code)	The value entered in the Reaction MedDRA field on the Case Drug History record.

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.1 Date of Death	The date entered in the Date of Death field on the Case.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text)	The text entered in the Name (Reported) field on the Reported Case Cause of Death object.
D.9.3 Was Autopsy Done?	The value selected in the Autopsy field on the Case.
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Autopsy-Determined Case Cause of Death object.
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text)	The information entered in the Name (Reported) field on the Autopsy-Determined Case Cause of Death object.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
D.10.1 Parent Identification	The value entered in the Patient ID field on the associated Parental-type Case.
D.10.2.1 Date of Birth of Parent	The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case.
D.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
D.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
D.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
D.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
D.10.6 Sex of Parent	The value entered in the Gender field on the associated Parent-type Case.
D.10.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.3 Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.5 Comments	The text entered in the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters.
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text entered in the Medical History Text field on the associated Parental-type Case, to a limit of 10,000 characters.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1 Name of Drug as Reported	The text entered in the Name Reported field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.5 End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.7b Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.

E.I Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	The text entered in the Event (Reported) field on the Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	The text entered in the Event (Reported) - Language field on the Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	The text entered in the Event (Reported) - English (`event_reported_english__v`) field on the Case Adverse Event.
E.i.2.1a MedDRA Version for Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code)	The value entered in the Event (MedDRA) field on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value selected in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name

Populated Value

E.i.3.2a Results in Death

Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2b Life Threatening

Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2c Caused / Prolonged Hospitalisation

Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2d Disabling / Incapacitating

Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2e Congenital Anomaly / Birth Defect

Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2f Other Medically Important Condition

Set to True when Other medically important condition is selected in the Seriousness field on the Case Adverse Event.

E.i.4 Date of Start of Reaction / Event

The date entered in the Onset field on the Case Adverse Event.

E.i.5 Date of End of Reaction / Event

The date entered in the Resolved field on the Case Adverse Event.

E.i.6a Duration of Reaction / Event (number)

The value entered in the Duration field on the Case Adverse Event.

E.i.6b Duration of Reaction / Event (unit)

The unit entered in the Duration (unit) field on the Case Adverse Event.

E.i.7 Outcome of Reaction / Event at the Time of Last Observation

The value selected in the Outcome field on the Case Adverse Event.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Recovered/Resolved	1 - Recovered/Resolved
2 - Recovering/Resolving	2 - Recovering/Resolving
3 - Not Recovered/Not Resolved/Ongoing	3 - Not Recovered/Not Resolved.Ongoing
4 - Recovered/Resolved with Sequelae	4 - Recovered/Resolved with Sequelae
5 - Fatal	5 - Fatal
0 - Unknown	0 - Unknown

E.i.8 Medical Confirmation by Healthcare Professional

Populated based on the value in the HCP Confirmed field on the Case Adverse Event. This field is only transmitted when the Qualification field on the primary (Rank 1) Reporter-type Case Contact does not designate a health professional. That is, the Qualification Controlled Vocabulary does not correspond to E2B codes 1, 2, or 3.

E.i.9 Identification of the Country Where the Reaction / Event Occurred

The value entered in the Event Country field on the Case Adverse Event.

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

E2B Data Element Name	Populated Value
F.r.1 Test Date	The date entered in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The information entered in the Test Name (Reported) field on the Case Test Result.
F.r.2.2a MedDRA Version for Test Name	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code)	The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code)	The value selected in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.3 Test Result (unit)	The unit selected in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Case Test Result. In accordance with ICH guidelines, the system adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element.
F.r.4 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.5 Normal High Value	The unit and value entered in the Normal High Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.6 Comments (free text)	The information entered in the Comments field on the Case Test Result.
F.r.7 More Information Available	The value entered in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

E2B Data Element Name

Populated Value

G.k.1 Characterisation of Drug Role

The value entered in the Drug Role field on the Case Product record.

G.k.2.4 Identification of the Country Where the Drug Was Obtained

The value entered in the Country Obtained field on the Case Product record.

G.k.2.5 Investigational Product Blinded

The value entered in the Blinded field on the Case Product record.

G.k.5a Cumulative Dose to First Reaction (number)

The value entered in the Cumulative Dose field on the Case Product record.

G.k.5b Cumulative Dose to First Reaction (unit)

The unit selected in the Cumulative Dose (unit) field on the Case Product record.

G.k.6a Gestation Period at Time of Exposure (number)

The value entered in the Gestation Exposure field on the Case Product record.

G.k.6b Gestation Period at Time of Exposure (unit)

The unit selected in the Gestation Exposure (unit) field on the Case Product record.

G.k.8 Action(s) Taken with Drug

The value selected in the Action Taken field on the Case Product record.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Drug Withdrawn	1 - Drug Withdrawn
2 - Dose Reduced	2 - Dose Reduced
3 - Dose Increased	3 - Dose Increased
4 - Dose Not Changed	4 - Dose Not Changed
0 - Unknown	0 - Unknown
9 - Not Applicable	9 - Not Applicable

G.k.10.r Additional Information on Drug (coded)

The value selected in the Additional Information field on the Case Product record.

G.k.11 Additional Information on Drug (free text)

The information entered in the Additional Information (text) field on the Case Product record.

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.1.1a MPID Version Date / Number	The value entered in the MPID Version field on the Case Product record.
G.k.2.1.1b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Product record.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	The information entered in the Product (Reported) field on the Case Product record.

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name	The information entered in the Name (Reported) field on the Case Product Substance.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value entered in the TermID Version field on the Case Product Substance.
G.k.2.3.r.2b Substance / Specified Substance TermID	The value entered in the TermID field on the Case Product Substance.
G.k.2.3.r.3a Strength (number)	The value entered in the Strength (Number) field on the Case Product Substance.
G.k.2.3.r.3b Strength (unit)	The unit selected in the Strength (Unit) field on the Case Product Substance.

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name	Populated Value
G.k.3.1 Authorisation / Application Number	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
G.k.3.2 Country of Authorisation / Application	If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
G.k.3.3 Name of Holder / Applicant	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.1a Dose (number)	The value entered in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit selected in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value entered in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit selected in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The information entered in the First Administration field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The information entered in the Last Administration field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The value entered in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit selected in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
G.k.4.r.8 Dosage Text	The information entered in the Dose Text field on the Case Product Dosage.
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	The information entered in the Dose Form Text field on the Case Product Dosage.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	The information entered in the Dose Form TermID Version field on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	The information entered in the Dose Form TermID field on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration	The value in the Patient RoA field on the Case Product Dosage. This field is only included if structured data is not provided in G.k.4.r.10.2a/b.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	The information entered in the Patient RoA TermID Version field on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID	The value entered in the Patient RoA TermID field on the Case Product Dosage.
G.k.4.r.11.1 Parent Route of Administration (free text)	The value in the Parent RoA field on the Case Product Dosage.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	The information entered in the Parent RoA TermID Version field on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID	The value entered in the Parent RoA TermID field on the Case Product Dosage.

G.k.7.r Indication for Use in Case

E2B Data Element Name	Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source	The text from the Name (Reported) field on the Case Product Indication.
G.k.7.r.2a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code)	The MedDRA LLT coded on the Case Product Indication.

G.k.9.i Drug-reaction(s) / Event(s) Matrix

E2B Data Element Name	Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed	The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)	The value entered in the First Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)	The unit selected in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)	The value entered in the Last Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)	The unit selected in the Last Dose Latency (unit) field on the Case Assessment.
G.k.9.i.4 Did Reaction Recur on Re-administration?	The appropriate value is populated, based on the option selected in the Reaction Recurrence field on the Case Assessment: `1`: yes - yes (rechallenge was done, reaction reccurred) `2`: yes - no (rechallenge was done, reaction did not recur) `3`: yes - unk (rechallenge was done, outcome unknown) `4`: no - n/a (no rechallenge was done, recurrance is not applicable)

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1 Source of Assessment	The system maps this value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Source (text) field.
G.k.9.i.2.r.2 Method of Assessment	The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Method (text) field.
G.k.9.i.2.r.3 Result of Assessment	The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority: If enabled, the value is mapped from the Assessment Result (Override) field. Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault. The system otherwise attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Result (text) field.

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative Text field on the Case, to a limit of 100,000 characters.
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The information entered in the Company Comments field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

H.3.r Sender's Diagnosis

E2B Data Element Name	Populated Value
H.3.r.1a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)	The MedDRA LLT coded on the Case Diagnosis.

H.5.r Case Summary and Reporter's Comments in Native Language

E2B Data Element Name	Populated Value
H.5.r.1a Case Summary and Reporter's Comments Text	If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters. For Domestic Cases with Localization Scope set to “Narrative” or blank, the Localized Narrative document is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.
H.5.r.1b Case Summary and Reporter's Comments Language	The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative. For Domestic Cases with Localization Scope set to “Narrative” or blank, the language selected on the Localized Narrative document (Document field (`language_iso__v`) is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.

FDA VAERS E2B(R3) Mapping

The following tables define how each E2B data element is mapped for an FDA VAERS E2B(R3) file. Use the button below to toggle only regional FDA mappings that are different from the ICH mappings.

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
N.1.1 Types of Message in batch	This value is always `1` for ICH ICSR.
N.1.2 Batch Number	The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	The value entered in the UID field on the Case.
N.2.r.2 Message Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value

C.1.1 Sender's (case) Safety Report Unique Identifier The value from the UID field on the Case Number object.

C.1.2 Date of Creation The date entered in the Approval Date field if the Case is Approved or Closed.
If Approval Date is unavailable, the date of report generation or Transmission with a system warning.
Otherwise, the date and time when the report was generated or Transmitted, calculated with full precision down to the second.

C.1.3 Type of Report

The appropriate value is populated, based on the option selected in the Report Type field on the Case:

1: Spontaneous
2: Study
3: Other
4: Unknown

C.1.4 Date Report Was First Received from Source

For initial Cases, the date entered in the Receipt Date field on the Case.
For Follow-Up Cases, the date entered in the Initial Receipt Date field on the Case.

C.1.5 Date of Most Recent Information for This Report The date entered in the New Info Date field on the Case.

C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?

If the Local Expedited Criteria (case_expedited__v) field on the Transmission (Submission or Distribution) record has a value, the system uses this value. If this field is not specified on the Transmission, the system looks at the Expedited field on the Case.

If the value is Yes, this element is populated with 1 (expedited). Otherwise, this element is populated with 2 (non-expedited).

FDA.C.1.7.1 Local Criteria Report Type

If the primary product is set to Combination Product or if there are Vaccine Case Products, this field will auto-generate when the E2B file is created.

The system uses the following logic to populate this field:

Populated E2B Code	Conditions
-	FDA.C.1.12 Combination Product Report Flag	C.1.7 Expedited Report Flag	Device Report Type Field
`1`	No	Yes	N/A
`1`	Yes	Yes	Blank
`2`	No	No	N/A
`2`	Yes	No	Blank
`4`	Yes	Yes	Public Health Risk
`5`	Yes	No	Malfunction Only

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1 Are Additional Documents Available?	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender	The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank.
C.1.6.1.r.2 Included Documents	If any documents are attached to the Case with the document type of Case > Source > Attachment, they will be encoded.
FDA.C.1.6.1.r.3 Attachment File Name	The Case > Document > Filename for the attachment encoded in the transmission.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The value entered in the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case	The value entered in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case.
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value entered in the Source field on each Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.9.1.r.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment	The appropriate value is populated, based on the option selected in the Reason field on the Transmission: `1`: Nullification `2`: Amendment
C.1.11.2 Reason for Nullification/Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.
FDA.C.1.12 Combination Product Report Flag	Set as "True" when any Case Product is of the type Combination Product.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.1.1 Reporter's Title	The value entered in the Title field on a Reporter-type Case Contact.
C.2.r.1.2 Reporter's Given Name	The value entered in the First Name field on a Reporter-type Case Contact.
C.2.r.1.3 Reporter's Middle Name	The value entered in the Middle Name field on a Reporter-type Case Contact.
C.2.r.1.4 Reporter's Family Name	The value entered in the Last Name field on a Reporter-type Case Contact.
C.2.r.2.1 Reporter’s Organisation	The value entered in the Organization field on a Reporter-type Case Contact.
C.2.r.2.2 Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street	The value entered in the Street Name field on a Reporter-type Case Contact.
FDA.C.2.r.2.3 Reporter's Street Address - LINE 2	The value entered in the Street Name - Line 2 field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province	Populates the State/Province field on the Case Contact object for the primary reporter. For Domestic Cases, the system checks if the state or province is mapped to a domestic state code on a Country State/Province record. If a record exists, the Domestic State Code is exported to this field. This is useful for countries, such as Spain or Italy, where the state code is required in submissions to the EMA. If no mapping exists, the text value entered in the State/Province field is exported to this element. Contact Veeva Support to update the mapping logic, which includes for primary Reporters and non-primary Reporters on Global and Localized Cases. In 22R3 (December 2022), this enhancement will only require configuration enablement.
FDA.C.2.r.2.5.1 Reporter's County	The value populated in the County field on a Reporter-type Case Contact.
C.2.r.2.6 Reporter's Postcode	The value entered in the Zip/Postal Code field on a Reporter-type Case Contact.
C.2.r.2.7 Reporter's Telephone	The value entered in the Telephone field on a Reporter-type Case Contact.
FDA.C.2.r.2.8 Reporter’s Email	The value populated in the Reporter's Email Address field on a Reporter-type Case Contact.
C.2.r.3 Reporter’s Country Code	The ISO code populated in the Country field on a Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the FDA Concept Code (NCI Concept Identifier) is mapped.
C.2.r.5 Primary Source for Regulatory Purposes	Populated with `1` (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name	Populated Value
C.3.1 Sender Type	The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Sender Type from the Organization on the Case.
C.3.2 Sender's Organisation	The value entered in the Organisation field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Organization on the Case.
C.3.3.1 Sender's Department	The value entered in the Department field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.2 Sender's Title	The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode	The value entered in the Zip/Postal Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.8 Sender's E-mail Address	The value entered in the Email field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.
C.4.r.2 Included Documents	Any documents attached to the Case with the document type of Case > Source > Literature and the Retransmit field set to Yes are included with the transmission.

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value entered in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The values entered in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value entered in the Patient Initials / ID field on the Case.
FDA.D.1a Patient Name Prefix	The value entered in the Title field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1b Patient First Name	The value entered in the First Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1c Patient Middle Name	The value entered in the Middle Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1d Patient Last Name	The value entered in the Last Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1e Patient Address Line 1	The value entered in the Street field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1f Patient Address Line 2	The value entered in the Street Line 2 field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1g Patient Address City	The value entered in the City field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1h Patient Address State or Foreign Province Name	The value entered in the State/Province field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1i Patient Address County	The value entered in the County field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1i Patient Address Country	The ISO country code for the country selected in the Country field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1k Patient Address Postal Code	The value entered in the Zip/Postal Code field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1l Patient Telephone	The value entered in the Telephone field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `tel:None`.
FDA.D.1m Patient Email	The value entered in the Email Address field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `mailto:None`.

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name	Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)	The value entered in the MRN - GP field on the Case.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)	The value entered in the MRN - Specialist field on the Case.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)	The value entered in the MRN - Hospital field on the Case.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)	The value entered in the MRN - Investigation field on the Case.

D.2 Age Information

E2B Data Element Name	Populated Value
D.2.1 Date of Birth	The date entered in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
FDA.D.2.1a Age at Time of Vaccination (number)	The number value entered in the Age at Vaccination field on the Case.
FDA.D.2.1a Age at Time of Vaccination (unit)	The unit selected in the Age at Vaccination field on the Case.
D.2.2a Age at Time of Onset of Reaction / Event (number)	The value entered in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The value selected in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number)	The value entered in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit selected in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter)	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted.
D.3 Body Weight (kg)	The value entered in the Weight field on the Case.
D.4 Height (cm)	The value entered in the Height (normalized) field on the Case.
D.5 Sex	The option populated in the Gender field on the Case.
D.6 Last Menstrual Period Date	The date entered in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
D.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object.
D.7.1.r.5 Comments	The text entered in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
D.7.1.r.6 Family History	The value selected in the Family History field on the Case Medical History object.
FDA.D.7.4a Illness at Time of Vaccination MedDRA Version	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
FDA.D.7.4a Illness at Time of Vaccination MedDRA Code	If a Case Medical History record has the Illness at Vaccination? field set to True, then this value is mapped from the MedDRA LLT coded on the Case Medical History. If the LLT term is not available, the PT term is populated.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Case, to a limit of 10,000 characters. For a Case identified as Malfunction Only, if the Patient Initials (`case_version__v.patient_id_value__v`) field is populated with "NONE", then this data element is set to "None".
D.7.3 Concomitant Therapies	Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.1 Name of Drug as Reported	The value entered in the Drug (Reported) field on the Case Drug History record.
D.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History record.
D.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History record.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History record.
D.8.r.5 End Date	The value entered in the End Date field on the Case Drug History record.
D.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code)	The value entered in the Reaction MedDRA field on the Case Drug History record.
FDA.D.8.r.8a Patient Age at Vaccination (number)	The number entered in the Age at Vaccination field on the Case Drug History record.
FDA.D.8.r.8b Patient Age at Vaccination (unit)	The unit selected in the Age at Vaccination field on the Case Drug History record.

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.1 Date of Death	The date entered in the Date of Death field on the Case.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text)	The text entered in the Name (Reported) field on the Reported Case Cause of Death object.
D.9.3 Was Autopsy Done?	The value selected in the Autopsy field on the Case.
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Autopsy-Determined Case Cause of Death object.
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text)	The information entered in the Name (Reported) field on the Autopsy-Determined Case Cause of Death object.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
D.10.1 Parent Identification	The value entered in the Patient ID field on the associated Parental-type Case.
D.10.2.1 Date of Birth of Parent	The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case.
D.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
FDA.D.10.2.2.1a Parent Age at Vaccination (number)	The number entered in the Age at Vaccination field on the associated Parental-type Case.
FDA.D.10.2.2.1b Parent Age at Vaccination (unit)	The unit selected in the Age at Vaccination field on the associated Parental-type Case.
D.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
D.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
D.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
D.10.6 Sex of Parent	The value entered in the Gender field on the associated Parent-type Case.
D.10.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.3 Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.5 Comments	The text entered in the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters.
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text entered in the Medical History Text field on the associated Parental-type Case, to a limit of 10,000 characters.
FDA.D.11 Patient Race Code	The appropriate NCI Concept Identifier is populated, based on the Race field on the Case.
FDA.D.12 Patient Ethnicity	The appropriate NCI Concept Identifier is populated, based on the Ethnicity field on the Case.
FDA.D.13 Pregnant at Time of Vaccination	The value from the Pregnant at Vaccination field on the Case.
FDA.D.14 Patient Military Status	The appropriate NCI Concept Identifier is populated, based on the Military Status field on the Case.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1 Name of Drug as Reported	The text entered in the Name Reported field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.5 End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.7b Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.

E.I Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	The text entered in the Event (Reported) field on the Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	The text entered in the Event (Reported) - Language field on the Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	The text entered in the Event (Reported) - English (`event_reported_english__v`) field on the Case Adverse Event.
FDA.E.i.1.3 Reaction Identifier	When G.k.9.i (Causality Assessment) is populated, this field is populated with the UUID/GUID Identifier to associate the event from the Case Adverse Event with the Causality Assessment.
E.i.2.1a MedDRA Version for Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code)	The value entered in the Event (MedDRA) field on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value selected in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name

Populated Value

E.i.3.2a Results in Death

Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2b Life Threatening

Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2c Caused / Prolonged Hospitalisation

Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.

FDA.E.i.3.2c.1 Hospitalization Required

Populated from the Hospitalization field on the Case Adverse Event.

FDA.E.i.3.2c.1a Number of days hospitalized

The value entered in the Days Hospitalized field on the Case Adverse Event.

FDA.E.i.3.2c.1b Hospital Name

The value entered in the Hospital Name field on the Case Adverse Event.

FDA.E.i.3.2c.1c City

The value entered in the Hospital City field on the Case Adverse Event.

FDA.E.i.3.2c.1d State

The value entered in the Hospital State field on the Case Adverse Event.

FDA.E.i.3.2c.2 Resulted in Prolongation of Hospitalization

Populated from the Hospitalization field on the Case Adverse Event.

E.i.3.2d Disabling / Incapacitating

Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2e Congenital Anomaly / Birth Defect

Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2f Other Medically Important Condition

Set to True when Other medically important condition is selected in the Seriousness field on the Case Adverse Event.

FDA.E.i.3.3a Emergency room/department or urgent care

Populated using the Evaluated/Treated At field on the Case Adverse Event.

FDA.E.i.3.3b Doctor or other HCP office/clinic visit

Populated using the Evaluated/Treated At field on the Case Adverse Event.

FDA.E.i.3.2g AE Outcome None of the Above

Populated as True when both the Seriousness and Evaluated/Treated At fields are blank on the Case Adverse Event.

FDA.E.i.3.4 Best doctor/healthcare professional title or prefix

The value entered in the Title field on the best doctor Health Care Professional Contact.

FDA.E.i.3.4a Best doctor/healthcare professional Last Name

The value entered in the Last Name field on the best doctor Health Care Professional Contact.

FDA.E.i.3.4b Best doctor/healthcare professional First Name

The value entered in the First Name field on the best doctor Health Care Professional Contact.

FDA.E.i.3.4c Best doctor/healthcare professional Middle Name

The value entered in the Middle Name field on the best doctor Health Care Professional Contact.

FDA.E.i.3.4d Best doctor/healthcare professional Telephone and extension

The value entered in the Telephone and Extension field on the best doctor Health Care Professional Contact.

FDA.E.i.3.4e Best doctor/healthcare professional Email

The value entered in the Email field on the best doctor Health Care Professional Contact.

E.i.4 Date of Start of Reaction / Event

The date entered in the Onset field on the Case Adverse Event.

E.i.5 Date of End of Reaction / Event

The date entered in the Resolved field on the Case Adverse Event.

E.i.6a Duration of Reaction / Event (number)

The value entered in the Duration field on the Case Adverse Event.

E.i.6b Duration of Reaction / Event (unit)

The unit entered in the Duration (unit) field on the Case Adverse Event.

E.i.7 Outcome of Reaction / Event at the Time of Last Observation

The value selected in the Outcome field on the Case Adverse Event.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Recovered/Resolved	1 - Recovered/Resolved
2 - Recovering/Resolving	2 - Recovering/Resolving
3 - Not Recovered/Not Resolved/Ongoing	3 - Not Recovered/Not Resolved.Ongoing
4 - Recovered/Resolved with Sequelae	4 - Recovered/Resolved with Sequelae
5 - Fatal	5 - Fatal
0 - Unknown	0 - Unknown

E.i.8 Medical Confirmation by Healthcare Professional

E.i.9 Identification of the Country Where the Reaction / Event Occurred

The value entered in the Event Country field on the Case Adverse Event.

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

E2B Data Element Name	Populated Value
F.r.1 Test Date	The date entered in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The information entered in the Test Name (Reported) field on the Case Test Result.
F.r.2.2a MedDRA Version for Test Name	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code)	The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code)	The value selected in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.3 Test Result (unit)	The unit selected in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Case Test Result. In accordance with ICH guidelines, the system adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided.
F.r.4 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.5 Normal High Value	The unit and value entered in the Normal High Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.6 Comments (free text)	The information entered in the Comments field on the Case Test Result.
F.r.7 More Information Available	The value entered in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

E2B Data Element Name Populated Value

G.k.1 Characterisation of Drug Role The value entered in the Drug Role field on the Case Product record.

G.k.1.a FDA Other Characterization of Drug Role Set to 1 when the Drug Role field on the Case Product record is set to Similar Device.

G.k.2.4 Identification of the Country Where the Drug Was Obtained The value entered in the Country Obtained field on the Case Product record.

G.k.2.5 Investigational Product Blinded The value entered in the Blinded field on the Case Product record.

G.k.5a Cumulative Dose to First Reaction (number) The value entered in the Cumulative Dose field on the Case Product record.

G.k.5b Cumulative Dose to First Reaction (unit) The unit selected in the Cumulative Dose (unit) field on the Case Product record.

G.k.6a Gestation Period at Time of Exposure (number) The value entered in the Gestation Exposure field on the Case Product record.

G.k.6b Gestation Period at Time of Exposure (unit) The unit selected in the Gestation Exposure (unit) field on the Case Product record.

G.k.8 Action(s) Taken with Drug

The value selected in the Action Taken field on the Case Product record.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Drug Withdrawn	1 - Drug Withdrawn
2 - Dose Reduced	2 - Dose Reduced
3 - Dose Increased	3 - Dose Increased
4 - Dose Not Changed	4 - Dose Not Changed
0 - Unknown	0 - Unknown
9 - Not Applicable	9 - Not Applicable

G.k.10.r Additional Information on Drug (coded) The value selected in the Additional Information field on the Case Product record.

FDA.G.k.10.r.1 FDA Specialized Product Category The value selected in the Combination Type field for the Combination Product record associated with the Case Product.

G.k.11 Additional Information on Drug (free text) The information entered in the Additional Information (text) field on the Case Product record.

G.k.4.r.14 Vaccination Facility

E2B Data Element Name	Populated Value
FDA.G.k.4.r.14 Vaccination Facility Name	Mapped from the Facility Name field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1a Vaccination Facility Address Line 1	Mapped from the Street field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1b Vaccination Facility Address Line 2	Mapped from the Street Line 2 field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.2 Vaccination Facility City	Mapped from the City field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.3 Vaccination Facility State	Mapped from the State/Province field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.4 Vaccination Facility Country	Mapped from the Country field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.5 Vaccination Facility Postal Code	Mapped from the Zip/Postal Code field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.6 Vaccination Facility Telephone	Mapped from the Telephone field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.7 Vaccination Facility Fax	Mapped from the Fax field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.8 Vaccination Facility Type	The appropriate NCI Concept Identifier is populated, based on the Facility Type on the Facility Case Contact selected in the Administration Facility field on the Case Product Dosage.
FDA.G.k.4.r.14.9 Vaccination Facility Military Flag	Mapped from the Facility Military Flag field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.1.1a MPID Version Date / Number	The value entered in the MPID Version field on the Case Product record.
G.k.2.1.1b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Product record.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	The information entered in the Product (Reported) field on the Case Product record.
FDA.G.k.2.2.1 U.S. Generic Name	The Generic Name field on the Product record associated with the Case Product record.

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name	The information entered in the Name (Reported) field on the Case Product Substance.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value entered in the TermID Version field on the Case Product Substance.
G.k.2.3.r.2b Substance / Specified Substance TermID	The value entered in the TermID field on the Case Product Substance.
G.k.2.3.r.3a Strength (number)	The value entered in the Strength (Number) field on the Case Product Substance.
G.k.2.3.r.3b Strength (unit)	The unit selected in the Strength (Unit) field on the Case Product Substance.

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name	Populated Value
G.k.3.1 Authorisation / Application Number	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
G.k.3.2 Country of Authorisation / Application	If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
G.k.3.3 Name of Holder / Applicant	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.1a Dose (number)	The value entered in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit selected in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value entered in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit selected in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The information entered in the First Administration field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The information entered in the Last Administration field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The value entered in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit selected in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
G.k.4.r.8 Dosage Text	The information entered in the Dose Text field on the Case Product Dosage.
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	The information entered in the Dose Form Text field on the Case Product Dosage.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	The information entered in the Dose Form TermID Version field on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	The information entered in the Dose Form TermID field on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration	The value in the Patient RoA field on the Case Product Dosage. This field is only included if structured data is not provided in G.k.4.r.10.2a/b.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	The information entered in the Patient RoA TermID Version field on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID	The value entered in the Patient RoA TermID field on the Case Product Dosage.
G.k.4.r.11.1 Parent Route of Administration (free text)	The value in the Parent RoA field on the Case Product Dosage.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	The information entered in the Parent RoA TermID Version field on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID	The value entered in the Parent RoA TermID field on the Case Product Dosage.
FDA.G.k.4.r.12 Vaccine Anatomical Approach Site	The appropriate NCI Concept Identifier is populated, based on the Anatomical Site field on the Case Product Dosage.
FDA.G.k.4.r.13 Dose Number in Series	The value selected in the Dose Number in Series field on the Case Product Dosage.

G.k.7.r Indication for Use in Case

E2B Data Element Name	Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source	The text from the Name (Reported) field on the Case Product Indication.
G.k.7.r.2a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code)	The MedDRA LLT coded on the Case Product Indication.

G.k.9.i Drug-reaction(s) / Event(s) Matrix

E2B Data Element Name	Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed	The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)	The value entered in the First Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)	The unit selected in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)	The value entered in the Last Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)	The unit selected in the Last Dose Latency (unit) field on the Case Assessment.
G.k.9.i.4 Did Reaction Recur on Re-administration?	The appropriate value is populated, based on the option selected in the Reaction Recurrence field on the Case Assessment: `1`: yes - yes (rechallenge was done, reaction reccurred) `2`: yes - no (rechallenge was done, reaction did not recur) `3`: yes - unk (rechallenge was done, outcome unknown) `4`: no - n/a (no rechallenge was done, recurrance is not applicable)

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1 Source of Assessment	The system maps this value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Source (text) field.
G.k.9.i.2.r.2 Method of Assessment	The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Method (text) field.
G.k.9.i.2.r.3 Result of Assessment	The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority: If enabled, the value is mapped from the Assessment Result (Override) field. Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault. The system otherwise attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Result (text) field.

G.k.12 Device Information

E2B Data Element Name	Populated Value
FDA.G.k.12.r.1 Malfunction	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Malfunction field on the Case Product is set to Yes. If the field is blank on the Case Product, the system populates this element when the Device Report Type field on the Case contains Malfunction.
FDA.G.k.12.r.2.r If follow-up, what type?	This element is populated with the value from the Device Follow-Up Type field on the Case
FDA.G.k.12.r.3.r Device Problem Code	For each Combination Product Device Constituent, this element is populated with the level 1, 2, or 3 harmonized FDA/IMDRF code that was entered on the Case. Otherwise, the value is mapped from the Device Problem field on the device-type Case Product.
FDA.G.k.12.r.4 Device Brand Name	The value entered in the Product Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.5 Common Device Name	The value entered in the Generic Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.6 Device Product Code	The value entered in the Product Code field on the Product Registration record associated with the device-type Case Product.
FDA.G.k.12.r.7.1a Device Manufacturer Name	The Name of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1b Device Manufacturer Address	The Address of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1c Device Manufacturer City	The City of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1d Device Manufacturer State	The State of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1e Device Manufacturer Country	The Country of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.8 Device Usage	The value selected on the Device Usage Type field on the Case Product record.
FDA.G.k.12.r.9 Device Lot Number	The value entered in the Lot Number field on the Case Product record.
FDA.G.k.12.r.10a Operator of the Device	The value entered in the device Operator of the Device field on the Case Product record.
FDA.G.k.12.r.11.r Remedial Action Initiated	For each Combination Product Device Constituent, for each remedial action selected in the Remedial Action field on the Case Product, the system populates the following values: `1` (Recall) `2` (Repair) `3` (Replacement) `4` (Relabeling) `5` (Notification) `6` (Inspection) `7` (Patient Monitoring) `8` (Modification/Adjustment) `9` (Other) If the field is blank on the Case Product, the system populates this element based on the Remedial Action field on the Case, if available.

FDA.G2 Vaccines Given Within 4 Weeks Organizer

E2B Data Element Name	Populated Value
FDA.G2.k.1 Vaccine Type	The value from the Vaccine Type field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.2a MPID Version Date / Number	The value from the MPID Version field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.2b Medicinal Product Identifier (MPID)	The value from the MPID field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.3 Date Given	The value for the First Admin Date field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4a Route of Administration TermID Version Date / Number	The FDA Concept Code Version from the Patient RoA Version field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4b Route of Administration TermID	The FDA Concept Code for the value selected in the Patient RoA field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.5 Vaccine Anatomical Approach Site	The FDA Concept Code for the value selected in the Anatomical Site field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.6 Dose Number in Series	The value from the Dose Number in Series field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.7 Lot Number	The value from the Batch/Lot Number field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.8 Manufacturer Name	The value from the Manufacturer field on the Product record for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative Text field on the Case, to a limit of 100,000 characters.
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The information entered in the Company Comments field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

H.3.r Sender's Diagnosis

E2B Data Element Name	Populated Value
H.3.r.1a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)	The MedDRA LLT coded on the Case Diagnosis.

H.5.r Case Summary and Reporter's Comments in Native Language

E2B Data Element Name	Populated Value
H.5.r.1a Case Summary and Reporter's Comments Text	If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters. For Domestic Cases with Localization Scope set to “Narrative” or blank, the Localized Narrative document is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.
H.5.r.1b Case Summary and Reporter's Comments Language	The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative. For Domestic Cases with Localization Scope set to “Narrative” or blank, the language selected on the Localized Narrative document (Document field (`language_iso__v`) is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value

FDA.C.1.7.1 Local Criteria Report Type

If the primary product is set to Combination Product or if there are Vaccine Case Products, this field will auto-generate when the E2B file is created.

The system uses the following logic to populate this field:

Populated E2B Code	Conditions
-	FDA.C.1.12 Combination Product Report Flag	C.1.7 Expedited Report Flag	Device Report Type Field
`1`	No	Yes	N/A
`1`	Yes	Yes	Blank
`2`	No	No	N/A
`2`	Yes	No	Blank
`4`	Yes	Yes	Public Health Risk
`5`	Yes	No	Malfunction Only

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
FDA.C.1.6.1.r.3 Attachment File Name	The Case > Document > Filename for the attachment encoded in the transmission.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
FDA.C.1.12 Combination Product Report Flag	Set as "True" when any Case Product is of the type Combination Product.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
FDA.C.2.r.2.3 Reporter's Street Address - LINE 2	The value entered in the Street Name - Line 2 field on a Reporter-type Case Contact.
FDA.C.2.r.2.5.1 Reporter's County	The value populated in the County field on a Reporter-type Case Contact.
FDA.C.2.r.2.8 Reporter’s Email	The value populated in the Reporter's Email Address field on a Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the FDA Concept Code (NCI Concept Identifier) is mapped.

D Patient Characteristics

E2B Data Element Name	Populated Value
FDA.D.1a Patient Name Prefix	The value entered in the Title field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1b Patient First Name	The value entered in the First Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1c Patient Middle Name	The value entered in the Middle Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1d Patient Last Name	The value entered in the Last Name field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1e Patient Address Line 1	The value entered in the Street field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1f Patient Address Line 2	The value entered in the Street Line 2 field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1g Patient Address City	The value entered in the City field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1h Patient Address State or Foreign Province Name	The value entered in the State/Province field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1i Patient Address County	The value entered in the County field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1i Patient Address Country	The ISO country code for the country selected in the Country field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1k Patient Address Postal Code	The value entered in the Zip/Postal Code field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `None`.
FDA.D.1l Patient Telephone	The value entered in the Telephone field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `tel:None`.
FDA.D.1m Patient Email	The value entered in the Email Address field on the Patient-type Case Contact. For Malfunction Only cases, if the Patient Initials (`patient_id_value__v`) field is populated with "NONE", this element is set to `mailto:None`.

D.2 Age Information

E2B Data Element Name	Populated Value
FDA.D.2.1a Age at Time of Vaccination (number)	The number value entered in the Age at Vaccination field on the Case.
FDA.D.2.1a Age at Time of Vaccination (unit)	The unit selected in the Age at Vaccination field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
FDA.D.7.4a Illness at Time of Vaccination MedDRA Version	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
FDA.D.7.4a Illness at Time of Vaccination MedDRA Code	If a Case Medical History record has the Illness at Vaccination? field set to True, then this value is mapped from the MedDRA LLT coded on the Case Medical History. If the LLT term is not available, the PT term is populated.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Case, to a limit of 10,000 characters. For a Case identified as Malfunction Only, if the Patient Initials (`case_version__v.patient_id_value__v`) field is populated with "NONE", then this data element is set to "None".

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
FDA.D.8.r.8a Patient Age at Vaccination (number)	The number entered in the Age at Vaccination field on the Case Drug History record.
FDA.D.8.r.8b Patient Age at Vaccination (unit)	The unit selected in the Age at Vaccination field on the Case Drug History record.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
FDA.D.10.2.2.1a Parent Age at Vaccination (number)	The number entered in the Age at Vaccination field on the associated Parental-type Case.
FDA.D.10.2.2.1b Parent Age at Vaccination (unit)	The unit selected in the Age at Vaccination field on the associated Parental-type Case.
FDA.D.11 Patient Race Code	The appropriate NCI Concept Identifier is populated, based on the Race field on the Case.
FDA.D.12 Patient Ethnicity	The appropriate NCI Concept Identifier is populated, based on the Ethnicity field on the Case.
FDA.D.13 Pregnant at Time of Vaccination	The value from the Pregnant at Vaccination field on the Case.
FDA.D.14 Patient Military Status	The appropriate NCI Concept Identifier is populated, based on the Military Status field on the Case.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name	Populated Value
FDA.E.i.3.2c.1 Hospitalization Required	Populated from the Hospitalization field on the Case Adverse Event.
FDA.E.i.3.2c.1a Number of days hospitalized	The value entered in the Days Hospitalized field on the Case Adverse Event.
FDA.E.i.3.2c.1b Hospital Name	The value entered in the Hospital Name field on the Case Adverse Event.
FDA.E.i.3.2c.1c City	The value entered in the Hospital City field on the Case Adverse Event.
FDA.E.i.3.2c.1d State	The value entered in the Hospital State field on the Case Adverse Event.
FDA.E.i.3.2c.2 Resulted in Prolongation of Hospitalization	Populated from the Hospitalization field on the Case Adverse Event.
FDA.E.i.3.3a Emergency room/department or urgent care	Populated using the Evaluated/Treated At field on the Case Adverse Event.
FDA.E.i.3.3b Doctor or other HCP office/clinic visit	Populated using the Evaluated/Treated At field on the Case Adverse Event.
FDA.E.i.3.2g AE Outcome None of the Above	Populated as True when both the Seriousness and Evaluated/Treated At fields are blank on the Case Adverse Event.
FDA.E.i.3.4 Best doctor/healthcare professional title or prefix	The value entered in the Title field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4a Best doctor/healthcare professional Last Name	The value entered in the Last Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4b Best doctor/healthcare professional First Name	The value entered in the First Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4c Best doctor/healthcare professional Middle Name	The value entered in the Middle Name field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4d Best doctor/healthcare professional Telephone and extension	The value entered in the Telephone and Extension field on the best doctor Health Care Professional Contact.
FDA.E.i.3.4e Best doctor/healthcare professional Email	The value entered in the Email field on the best doctor Health Care Professional Contact.

G.k Drug(s) Information

E2B Data Element Name	Populated Value
G.k.1.a FDA Other Characterization of Drug Role	Set to `1` when the Drug Role field on the Case Product record is set to Similar Device.
FDA.G.k.10.r.1 FDA Specialized Product Category	The value selected in the Combination Type field for the Combination Product record associated with the Case Product.

G.k.4.r.14 Vaccination Facility

E2B Data Element Name	Populated Value
FDA.G.k.4.r.14 Vaccination Facility Name	Mapped from the Facility Name field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1a Vaccination Facility Address Line 1	Mapped from the Street field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.1b Vaccination Facility Address Line 2	Mapped from the Street Line 2 field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.2 Vaccination Facility City	Mapped from the City field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.3 Vaccination Facility State	Mapped from the State/Province field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.4 Vaccination Facility Country	Mapped from the Country field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.5 Vaccination Facility Postal Code	Mapped from the Zip/Postal Code field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.6 Vaccination Facility Telephone	Mapped from the Telephone field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.7 Vaccination Facility Fax	Mapped from the Fax field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.
FDA.G.k.4.r.14.8 Vaccination Facility Type	The appropriate NCI Concept Identifier is populated, based on the Facility Type on the Facility Case Contact selected in the Administration Facility field on the Case Product Dosage.
FDA.G.k.4.r.14.9 Vaccination Facility Military Flag	Mapped from the Facility Military Flag field for the Facility selected in the Administration Facility field on the Case Product Dosage for the Vaccine- or Company Product-type Case Product.

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
FDA.G.k.2.2.1 U.S. Generic Name	The Generic Name field on the Product record associated with the Case Product record.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
FDA.G.k.4.r.12 Vaccine Anatomical Approach Site	The appropriate NCI Concept Identifier is populated, based on the Anatomical Site field on the Case Product Dosage.
FDA.G.k.4.r.13 Dose Number in Series	The value selected in the Dose Number in Series field on the Case Product Dosage.

G.k.12 Device Information

E2B Data Element Name	Populated Value
FDA.G.k.12.r.1 Malfunction	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Malfunction field on the Case Product is set to Yes. If the field is blank on the Case Product, the system populates this element when the Device Report Type field on the Case contains Malfunction.
FDA.G.k.12.r.2.r If follow-up, what type?	This element is populated with the value from the Device Follow-Up Type field on the Case
FDA.G.k.12.r.3.r Device Problem Code	For each Combination Product Device Constituent, this element is populated with the level 1, 2, or 3 harmonized FDA/IMDRF code that was entered on the Case. Otherwise, the value is mapped from the Device Problem field on the device-type Case Product.
FDA.G.k.12.r.4 Device Brand Name	The value entered in the Product Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.5 Common Device Name	The value entered in the Generic Name field on the Product record associated with the device-type Case Product.
FDA.G.k.12.r.6 Device Product Code	The value entered in the Product Code field on the Product Registration record associated with the device-type Case Product.
FDA.G.k.12.r.7.1a Device Manufacturer Name	The Name of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1b Device Manufacturer Address	The Address of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1c Device Manufacturer City	The City of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1d Device Manufacturer State	The State of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.7.1e Device Manufacturer Country	The Country of the Manufacturer selected on the associated Product record.
FDA.G.k.12.r.8 Device Usage	The value selected on the Device Usage Type field on the Case Product record.
FDA.G.k.12.r.9 Device Lot Number	The value entered in the Lot Number field on the Case Product record.
FDA.G.k.12.r.10a Operator of the Device	The value entered in the device Operator of the Device field on the Case Product record.
FDA.G.k.12.r.11.r Remedial Action Initiated	For each Combination Product Device Constituent, for each remedial action selected in the Remedial Action field on the Case Product, the system populates the following values: `1` (Recall) `2` (Repair) `3` (Replacement) `4` (Relabeling) `5` (Notification) `6` (Inspection) `7` (Patient Monitoring) `8` (Modification/Adjustment) `9` (Other) If the field is blank on the Case Product, the system populates this element based on the Remedial Action field on the Case, if available.

FDA.G2 Vaccines Given Within 4 Weeks Organizer

E2B Data Element Name	Populated Value
FDA.G2.k.1 Vaccine Type	The value from the Vaccine Type field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.2a MPID Version Date / Number	The value from the MPID Version field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.2b Medicinal Product Identifier (MPID)	The value from the MPID field on non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.3 Date Given	The value for the First Admin Date field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4a Route of Administration TermID Version Date / Number	The FDA Concept Code Version from the Patient RoA Version field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.4b Route of Administration TermID	The FDA Concept Code for the value selected in the Patient RoA field on the Case Product Dosage for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.5 Vaccine Anatomical Approach Site	The FDA Concept Code for the value selected in the Anatomical Site field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.6 Dose Number in Series	The value from the Dose Number in Series field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.7 Lot Number	The value from the Batch/Lot Number field on the earliest Case Product Dosages for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.
FDA.G2.k.8 Manufacturer Name	The value from the Manufacturer field on the Product record for non-primary Vaccine-type Case Products administered within 4 weeks of the primary Vaccine-type Case Product.

EMA E2B(R3) Mapping

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
N.1.1 Types of Message in batch	This value is always `1` for ICH ICSR.
N.1.2 Batch Number	The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	The value entered in the UID field on the Case.
N.2.r.2 Message Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

C.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier	The value from the UID field on the Case Number object.
C.1.2 Date of Creation	The date entered in the Approval Date field if the Case is Approved or Closed. If Approval Date is unavailable, the date of report generation or Transmission with a system warning. Otherwise, the date and time when the report was generated or Transmitted, calculated with full precision down to the second.
C.1.3 Type of Report	The appropriate value is populated, based on the option selected in the Report Type field on the Case: `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
C.1.4 Date Report Was First Received from Source	For initial Cases, the date entered in the Receipt Date field on the Case. For Follow-Up Cases, the date entered in the Initial Receipt Date field on the Case.
C.1.5 Date of Most Recent Information for This Report	The date entered in the New Info Date field on the Case.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?	If the Local Expedited Criteria (`case_expedited__v`) field on the Transmission (Submission or Distribution) record has a value, the system uses this value. If this field is not specified on the Transmission, the system looks at the Expedited field on the Case. If the value is Yes, this element is populated with `1` (expedited). Otherwise, this element is populated with `2` (non-expedited).

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1 Are Additional Documents Available?	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender	The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank.
C.1.6.1.r.2 Included Documents	If any documents are attached to the Case with the document type of Case > Source > Attachment, they will be encoded.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The value entered in the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case	The value entered in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case.
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value entered in the Source field on each Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.9.1.r.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment	The appropriate value is populated, based on the option selected in the Reason field on the Transmission: `1`: Nullification `2`: Amendment
C.1.11.2 Reason for Nullification/Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.1.1 Reporter's Title	The value entered in the Title field on a Reporter-type Case Contact.
C.2.r.1.2 Reporter's Given Name	The value entered in the First Name field on a Reporter-type Case Contact.
C.2.r.1.3 Reporter's Middle Name	The value entered in the Middle Name field on a Reporter-type Case Contact.
C.2.r.1.4 Reporter's Family Name	The value entered in the Last Name field on a Reporter-type Case Contact.
C.2.r.2.1 Reporter’s Organisation	The value entered in the Organization field on a Reporter-type Case Contact.
C.2.r.2.2 Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street	The value entered in the Street Name field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province	Populates the State/Province field on the Case Contact object for the primary reporter. For Domestic Cases, the system checks if the state or province is mapped to a domestic state code on a Country State/Province record. If a record exists, the Domestic State Code is exported to this field. This is useful for countries, such as Spain or Italy, where the state code is required in submissions to the EMA. If no mapping exists, the text value entered in the State/Province field is exported to this element. Contact Veeva Support to update the mapping logic, which includes for primary Reporters and non-primary Reporters on Global and Localized Cases. In 22R3 (December 2022), this enhancement will only require configuration enablement.
C.2.r.2.6 Reporter's Postcode	The value entered in the Zip/Postal Code field on a Reporter-type Case Contact.
C.2.r.2.7 Reporter's Telephone	The value entered in the Telephone field on a Reporter-type Case Contact.
C.2.r.3 Reporter’s Country Code	The ISO code populated in the Country field on a Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the E2B code of `5` is mapped.
C.2.r.5 Primary Source for Regulatory Purposes	Populated with `1` (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name	Populated Value
C.3.1 Sender Type	The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Sender Type from the Organization on the Case.
C.3.2 Sender's Organisation	The value entered in the Organisation field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Organization on the Case.
C.3.3.1 Sender's Department	The value entered in the Department field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.2 Sender's Title	The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode	The value entered in the Zip/Postal Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.8 Sender's E-mail Address	The value entered in the Email field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.
C.4.r.2 Included Documents	Any documents attached to the Case with the document type of Case > Source > Literature and the Retransmit field set to Yes are included with the transmission.

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value entered in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The values entered in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value entered in the Patient Initials / ID field on the Case.

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name	Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)	The value entered in the MRN - GP field on the Case.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)	The value entered in the MRN - Specialist field on the Case.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)	The value entered in the MRN - Hospital field on the Case.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)	The value entered in the MRN - Investigation field on the Case.

D.2 Age Information

E2B Data Element Name	Populated Value
D.2.1 Date of Birth	The date entered in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.2.2a Age at Time of Onset of Reaction / Event (number)	The value entered in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The value selected in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number)	The value entered in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit selected in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter)	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted.
D.3 Body Weight (kg)	The value entered in the Weight field on the Case.
D.4 Height (cm)	The value entered in the Height (normalized) field on the Case.
D.5 Sex	The option populated in the Gender field on the Case.
D.6 Last Menstrual Period Date	The date entered in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
D.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object.
D.7.1.r.5 Comments	The text entered in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
D.7.1.r.6 Family History	The value selected in the Family History field on the Case Medical History object.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Case, to a limit of 10,000 characters.
D.7.3 Concomitant Therapies	Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.1 Name of Drug as Reported	The value entered in the Drug (Reported) field on the Case Drug History record.
D.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History record.
D.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History record.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History record.
D.8.r.5 End Date	The value entered in the End Date field on the Case Drug History record.
D.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code)	The value entered in the Reaction MedDRA field on the Case Drug History record.

D.8.r.1 Name of Drug as Reported

E2B Data Element Name	Populated Value
D.8.r.1.EU.1 Name part - Invented name	The information entered in the Invented Name Part field on the Case Drug History object.
D.8.r.1.EU.2 Name part - Scientific name	The information entered in the Scientific Name Part field on the Case Drug History object.
D.8.r.1.EU.3 Name part - Trademark name	The information entered in the Trademark Name Part field on the Case Drug History object.
D.8.r.1.EU.4 Name part - Strength name	The information entered in the Strength Name Part field on the Case Drug History object.
D.8.r.1.EU.5 Name part - Form name	The information entered in the Form Name Part field on the Case Drug History object.
D.8.r.1.EU.6 Name part - Container name	The information entered in the Container Name Part field on the Case Drug History object.
D.8.r.1.EU.7 Name part - Device name	The information entered in the Device Name Part field on the Case Drug History object.
D.8.r.1.EU.8 Name part - Intended use name	The information entered in the Intended Use Name Part field on the Case Drug History object.

D.8.r.EU Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
D.8.r.EU.r.1 Substance / Specified Substance Name	The information entered in the Name (Reported) field on the Case Drug History Substance.
D.8.r.EU.r.2a Substance/Specified Substance TermID Version Date/Number	The value entered in the TermID Version field on the Case Drug History Substance.
D.8.r.EU.r.2b Substance/Specified Substance TermID	The value entered in the TermID field on the Case Drug History Substance.
D.8.r.EU.r.3a Strength (number)	The value entered in the Strength (Number) field on the Case Drug History Substance.
D.8.r.EU.r.3b Strength (unit)	The unit selected in the Strength (Unit) field on the Case Drug History Substance.

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.1 Date of Death	The date entered in the Date of Death field on the Case.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text)	The text entered in the Name (Reported) field on the Reported Case Cause of Death object.
D.9.3 Was Autopsy Done?	The value selected in the Autopsy field on the Case.
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Autopsy-Determined Case Cause of Death object.
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text)	The information entered in the Name (Reported) field on the Autopsy-Determined Case Cause of Death object.

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
D.10.1 Parent Identification	The value entered in the Patient ID field on the associated Parental-type Case.
D.10.2.1 Date of Birth of Parent	The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case.
D.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
D.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
D.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
D.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
D.10.6 Sex of Parent	The value entered in the Gender field on the associated Parent-type Case.
D.10.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.3 Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.5 Comments	The text entered in the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters.
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text entered in the Medical History Text field on the associated Parental-type Case, to a limit of 10,000 characters.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1 Name of Drug as Reported	The text entered in the Name Reported field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.5 End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.7b Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.

D.10.8.r.1 Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1.EU.1 Name part - Invented name	The information entered in the Invented Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.2 Name part - Scientific name	The information entered in the Scientific Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.3 Name part - Trademark name	The information entered in the Trademark Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.4 Name part - Strength name	The information entered in the Strength Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.5 Name part - Form name	The information entered in the Form Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.6 Name part - Container name	The information entered in the Container Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.7 Name part - Device name	The information entered in the Device Name Part field on the Case Drug History object on the associated Parental-Type Case.
D.10.8.r.1.EU.8 Name part - Intended use name	The information entered in the Intended Use Name Part field on the Case Drug History object on the associated Parental-Type Case.

D.10.8.r.EU Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
D.10.r.EU.r.1 Substance / Specified Substance Name	The information entered in the Name (Reported) field on the Case Drug History Substance object on the associated Parental-Type Case.
D.10.8.r.EU.r.2a Substance/Specified Substance TermID Version Date/Number	The value entered in the TermID Version field on the Case Drug History Substance object on the associated Parental-Type Case.
D.10.8.r.EU.r.2b Substance/Specified Substance TermID	The value entered in the TermID field on the Case Drug History Substance object on the associated Parental-Type Case.
D.10.8.r.EU.r.3a Strength (number)	The value entered in the Strength (Number) field on the Case Drug History Substance object on the associated Parental-Type Case.
D.10.8.r.EU.r.3b Strength (unit)	The unit selected in the Strength (Unit) field on the Case Drug History Substance object on the associated Parental-Type Case.

E.I Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	The text entered in the Event (Reported) field on the Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	The text entered in the Event (Reported) - Language field on the Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	The text entered in the Event (Reported) - English (`event_reported_english__v`) field on the Case Adverse Event.
E.i.2.1a MedDRA Version for Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code)	The value entered in the Event (MedDRA) field on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value selected in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name

Populated Value

E.i.3.2a Results in Death

Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2b Life Threatening

Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2c Caused / Prolonged Hospitalisation

Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2d Disabling / Incapacitating

Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2e Congenital Anomaly / Birth Defect

Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2f Other Medically Important Condition

Set to True when Other medically important condition is selected in the Seriousness field on the Case Adverse Event.

E.i.4 Date of Start of Reaction / Event

The date entered in the Onset field on the Case Adverse Event.

E.i.5 Date of End of Reaction / Event

The date entered in the Resolved field on the Case Adverse Event.

E.i.6a Duration of Reaction / Event (number)

The value entered in the Duration field on the Case Adverse Event.

E.i.6b Duration of Reaction / Event (unit)

The unit entered in the Duration (unit) field on the Case Adverse Event.

E.i.7 Outcome of Reaction / Event at the Time of Last Observation

The value selected in the Outcome field on the Case Adverse Event.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Recovered/Resolved	1 - Recovered/Resolved
2 - Recovering/Resolving	2 - Recovering/Resolving
3 - Not Recovered/Not Resolved/Ongoing	3 - Not Recovered/Not Resolved.Ongoing
4 - Recovered/Resolved with Sequelae	4 - Recovered/Resolved with Sequelae
5 - Fatal	5 - Fatal
0 - Unknown	0 - Unknown

E.i.8 Medical Confirmation by Healthcare Professional

E.i.9 Identification of the Country Where the Reaction / Event Occurred

The value entered in the Event Country field on the Case Adverse Event.

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

E2B Data Element Name	Populated Value
F.r.1 Test Date	The date entered in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The information entered in the Test Name (Reported) field on the Case Test Result.
F.r.2.2a MedDRA Version for Test Name	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code)	The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code)	The value selected in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.3 Test Result (unit)	The unit selected in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Case Test Result. In accordance with ICH guidelines, the system adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element.
F.r.4 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.5 Normal High Value	The unit and value entered in the Normal High Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.6 Comments (free text)	The information entered in the Comments field on the Case Test Result.
F.r.7 More Information Available	The value entered in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

E2B Data Element Name

Populated Value

G.k.1 Characterisation of Drug Role

The value entered in the Drug Role field on the Case Product record.

G.k.2.4 Identification of the Country Where the Drug Was Obtained

The value entered in the Country Obtained field on the Case Product record.

G.k.2.5 Investigational Product Blinded

The value entered in the Blinded field on the Case Product record.

G.k.5a Cumulative Dose to First Reaction (number)

The value entered in the Cumulative Dose field on the Case Product record.

G.k.5b Cumulative Dose to First Reaction (unit)

The unit selected in the Cumulative Dose (unit) field on the Case Product record.

G.k.6a Gestation Period at Time of Exposure (number)

The value entered in the Gestation Exposure field on the Case Product record.

G.k.6b Gestation Period at Time of Exposure (unit)

The unit selected in the Gestation Exposure (unit) field on the Case Product record.

G.k.8 Action(s) Taken with Drug

The value selected in the Action Taken field on the Case Product record.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Drug Withdrawn	1 - Drug Withdrawn
2 - Dose Reduced	2 - Dose Reduced
3 - Dose Increased	3 - Dose Increased
4 - Dose Not Changed	4 - Dose Not Changed
0 - Unknown	0 - Unknown
9 - Not Applicable	9 - Not Applicable

G.k.10.r Additional Information on Drug (coded)

The value selected in the Additional Information field on the Case Product record.

G.k.11 Additional Information on Drug (free text)

The information entered in the Additional Information (text) field on the Case Product record.

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.1.1a MPID Version Date / Number	The value entered in the MPID Version field on the Case Product record.
G.k.2.1.1b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Product record.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	The information entered in the Product (Reported) field on the Case Product record.
G.k.2.2.EU.9.r.1 Device Component Name	The information entered in the Product (Reported) field on the Case Product record for a device constituent in a Combination Product.
G.k.2.2.EU.9.r.4 Device Batch Lot Number	The information entered in the Lot Number field on the Case Product record for a device constituent in a Combination Product.

G.k.2.2 Medicinal Product Name as Reported by the Primary Source

E2B Data Element Name	Populated Value
G.k.2.2.EU.1 Name part - Invented name	The information entered in the Invented Name Part field on the Case Product record.
G.k.2.2.EU.2 Name part - Scientific name	The information entered in the Scientific Name Part field on the Case Product record.
G.k.2.2.EU.3 Name part - Trademark name	The information entered in the Trademark Name Part field on the Case Product record.
G.k.2.2.EU.4 Name part - Strength name	The information entered in the Strength Name Part field on the Case Product record.
G.k.2.2.EU.5 Name part - Form name	The information entered in the Form Name Part field on the Case Product record.
G.k.2.2.EU.6 Name part - Container name	The information entered in the Container Name Part field on the Case Product record.
G.k.2.2.EU.7 Name part - Device name	The information entered in the Device Name Part field on the Case Product record.
G.k.2.2.EU.8 Name part - Intended use name	The information entered in the Intended Use Name field on the Case Product record.

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name	The information entered in the Name (Reported) field on the Case Product Substance.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value entered in the TermID Version field on the Case Product Substance.
G.k.2.3.r.2b Substance / Specified Substance TermID	The value entered in the TermID field on the Case Product Substance.
G.k.2.3.r.3a Strength (number)	The value entered in the Strength (Number) field on the Case Product Substance.
G.k.2.3.r.3b Strength (unit)	The unit selected in the Strength (Unit) field on the Case Product Substance.

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name	Populated Value
G.k.3.1 Authorisation / Application Number	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
G.k.3.2 Country of Authorisation / Application	If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
G.k.3.3 Name of Holder / Applicant	If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product record. If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.1a Dose (number)	The value entered in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit selected in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value entered in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit selected in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The information entered in the First Administration field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The information entered in the Last Administration field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The value entered in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit selected in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is transmitted with nullFlavours when the following Reason Omitted values are set: Blank or Unknown: `UNK` Masked: `MSK` Asked But Unknown: `ASKU`
G.k.4.r.8 Dosage Text	The information entered in the Dose Text field on the Case Product Dosage.
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	If the Dose Form Text field value maps to a current EDQM Term, the EDQM Name field is exported. (`dose_form__v.edqm__v.edqmname__v`) If the field value does not map to a current EDQM Term, the Name field is exported. (`dose_form__v.name__v`)
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	If the Dose Form TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. (`dose_form__v.edqm__v.edqmversion__v`) If the field value does not map to a current EDQM Term, the field is not populated.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	If the Dose Form TermID field value maps to a current EDQM Term, the EDQM Code field is exported. (`dose_form__v.edqm__v.edqmcode__v`) If the field value does not map to a current EDQM Term, the field is not populated.
G.k.4.r.10.1 Route of Administration	If the Patient RoA field value maps to a current EDQM Term, the EDQM Name field is exported. (`patient_route_of_admin__v.edqm__v.edqmname__v`) If the field value does not map to a current EDQM Term, the Name field is exported. (`patient_route_of_admin__v.name__v`)
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	If the Patient RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. (`patient_route_of_admin__v.edqm__v.edqmversion__v`) If the field value does not map to a current EDQM Term, the field is not populated.
G.k.4.r.10.2b Route of Administration TermID	If the Patient RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. (`patient_route_of_admin__v.edqm__v.edqmcode__v`) If the field value does not map to a current EDQM Term, the field is not populated.
G.k.4.r.11.1 Parent Route of Administration (free text)	If the Parent RoA field value maps to a current EDQM Term, the EDQM Name field is exported. (`parent_route_of_admin__v.edqm__v.edqmname__v`) If the field value does not map to a current EDQM Term, the Name field is exported. (`parent_route_of_admin__v.name__v`)
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	If the Parent RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. (`parent_route_of_admin__v.edqm__v.edqmversion__v`) If the field value does not map to a current EDQM Term, the field is not populated.
G.k.4.r.11.2b Parent Route of Administration TermID	If the Parent RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. (`parent_route_of_admin__v.edqm__v.edqmcode__v`) If the field value does not map to a current EDQM Term, the field is not populated.

G.k.7.r Indication for Use in Case

E2B Data Element Name	Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source	The text from the Name (Reported) field on the Case Product Indication.
G.k.7.r.2a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code)	The MedDRA LLT coded on the Case Product Indication.

G.k.9.i Drug-reaction(s) / Event(s) Matrix

E2B Data Element Name	Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed	The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)	The value entered in the First Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)	The unit selected in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)	The value entered in the Last Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)	The unit selected in the Last Dose Latency (unit) field on the Case Assessment.
G.k.9.i.4 Did Reaction Recur on Re-administration?	The appropriate value is populated, based on the option selected in the Reaction Recurrence field on the Case Assessment: `1`: yes - yes (rechallenge was done, reaction reccurred) `2`: yes - no (rechallenge was done, reaction did not recur) `3`: yes - unk (rechallenge was done, outcome unknown) `4`: no - n/a (no rechallenge was done, recurrance is not applicable)

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1.EU.1 EU Source of Assessment	The system maps this value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Source (text) field.
G.k.9.i.2.r.2.EU.1 EU Method of Assessment	The system maps this value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary. If the system cannot map the E2B code, the system maps the free text value from the Method (text) field.
G.k.9.i.2.r.3.EU.1 EU Result of Assessment	The system maps the value from one of the following fields on the Case Assessment Result, ordered by priority: The system first attempts to map the E2B Code corresponding to the Assessment Result (Override) Controlled Vocabulary. If no E2B Code is specified, the system finds the record Name of the Assessment Result (Override) Controlled Vocabulary. Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault. If the Assessment Result (Override) is not available, the system attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary. If no E2B Code is specified, the system finds the record Name of the Assessment Result Controlled Vocabulary. If none of the above are available, the system maps the free text value from the Result (text) field.

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative Text field on the Case, to a limit of 100,000 characters.
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The information entered in the Company Comments field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

H.3.r Sender's Diagnosis

E2B Data Element Name	Populated Value
H.3.r.1a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)	The MedDRA LLT coded on the Case Diagnosis.

H.5.r Case Summary and Reporter's Comments in Native Language

E2B Data Element Name	Populated Value
H.5.r.1a Case Summary and Reporter's Comments Text	If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters. For Domestic Cases with Localization Scope set to “Narrative” or blank, the Localized Narrative document is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.
H.5.r.1b Case Summary and Reporter's Comments Language	The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative. For Domestic Cases with Localization Scope set to “Narrative” or blank, the language selected on the Localized Narrative document (Document field (`language_iso__v`) is populated to this element. This information is separate from the data captured by H.2 Reporter's Comments.

PMDA E2B(R3) Mapping

Note A Japan Localized Case must contain at least one Local Reporting Details record that includes a Case Product Registration assigned PMDA Rank 1 (primary) and a PMDA Transmission record. Otherwise, the system generates the entire PMDA E2B(R3) file using ICH E2B(R3) mappings instead.

Per PMDA guidance, certain data elements are transmitted only for specific PMDA Reporting Categories (J2.1a). The PMDA Reporting Categories for which each element is transmitted are outlined in the following Excel file: Data Transmitted by PMDA Reporting Category

The following tables define how each E2B data element is mapped for a PMDA E2B(R3) file. Use the button below to toggle only regional PMDA mappings that are different from the ICH mappings.

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
N.1.1 Types of Message in batch	This value is always `1` for ICH ICSR.
N.1.2 Batch Number	The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted. The time is converted to Japan Standard Time (JST) and transmitted in the format `CCYYMMDDhhmmss+0900`.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	For PMDA, the system generates this value during E2B generation using the following fields: `(case_version__v.reporter_country__v.abbreviation_2__v) (transmission_profile__v.origin_id__v) (local_reporting_details__v.report_uid__v)` For example: JP-VertBio-000001AB Note For the system to generate this value, all three fields must be populated. If any field is blank, this data element is not exported. PMDA requires that when multiple ICSRs are submitted from a single Case, N.2.r.1 and C.1.1 must be different for each ICSR. To achieve this, Vault Safety adds logic to append suffix (AA-ZZ) to the existing UID generation logic to make it unique per submission. The generated UID is stored in the Report UID field of the Local Reporting Details (`local_reporting_details__v.report_uid__v`) record.
N.2.r.2 Message Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation	The exact date and time when the report was generated, in the format `CCYYMMDDhhmmss+0900`. The time is converted to Japan Standard Time (JST).

C.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier	For PMDA, the system generates this value during E2B generation using the following fields: `(case_version__v.reporter_country__v.abbreviation_2__v) (transmission_profile__v.origin_id__v) (local_reporting_details__v.report_uid_v)` For example: JP-VertBio-000001AB Note For the system to generate this value, all three fields must be populated. If any field is blank, this data element is exported with no value populated. See N.2.r.1 for unique report UID generation.
C.1.2 Date of Creation	The exact date and time when the report was generated, in the format `CCYYMMDDhhmmss+0900`. The time is converted to Japan Standard Time (JST).
C.1.3 Type of Report	The appropriate value is populated, based on the option selected in the Report Type field on the Case: `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
C.1.4 Date Report Was First Received from Source	For initial Cases, the date entered in the Local Initial Receipt Date field on the Localized Case. If blank, the the date in the Receipt Date field on the Global Case is exported. For Follow-Up Cases, the date entered in the Local Initial Receipt Date field on the Localized Case. If blank, the date in the Initial Receipt Date field on the Global Case is exported.
C.1.5 Date of Most Recent Information for This Report	The date entered in the Local New Info Date field on the Localized Case. If blank, the date in the New Info Date field from the Global Case is exported.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report?	If the Local Expedited Criteria (`case_expedited__v`) field on the Transmission (Submission or Distribution) record has a value, the system uses this value. If this field is not specified on the Transmission, the system looks at the Expedited field on the Case. If the value is Yes, this element is populated with `1` (expedited). Otherwise, this element is populated with `2` (non-expedited).

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1 Are Additional Documents Available?	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender	The system first finds any file attached to the Case with the document type of Case > Source > Attachment. Then, the system retrieves the corresponding Japanese Localized Case Document and populates this element with the Attachment Description, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank. localized_case_document__v.attachment_description__v
C.1.6.1.r.2 Included Documents	If any documents are attached to the Case with the document type of Case > Source > Attachment, they will be encoded.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The value entered in the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case	The value entered in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case.
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value entered in the Source field on each Localized Case Identifier object under the Japanese Localized Case. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank. localized_case_identifier__v.source__v
C.1.9.1.r.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment	The appropriate value is populated, based on the option selected in the Reason field on the Transmission: `1`: Nullification `2`: Amendment
C.1.11.2 Reason for Nullification/Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.3 Reporter’s Country Code	The ISO code populated in the Country field on the primary Reporter-type Case Contact. This field is only transmitted if C.2.r.5 is set to `1` (Primary Source) for the corresponding Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the E2B code of `5` is mapped.
C.2.r.5 Primary Source for Regulatory Purposes	Populated with `1` (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name	Populated Value
C.3.1 Sender Type	The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Sender Type from the Organization on the Case.
C.3.2 Sender's Organisation	The Organization selected in the Origin field on the PMDA Transmission Profile. transmission_profile__v.origin_transmission_id__v
C.3.3.2 Sender's Title	The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode	The value entered in the Zip/Postal Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The system first finds any Case attachments with the document type of Case > Source > Literature. Then, the system retrieves the corresponding Japanese Localized Case Document and populates this element with the Reference, to a limit of 500 characters. localized_case_document__v.reference__v
C.4.r.2 Included Documents	Any documents attached to the Case with the document type of Case > Source > Literature and the Retransmit field set to Yes are included with the transmission.

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value entered in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The values entered in the Study Name and Study Name (Continued) fields on the associated Japanese Localized Case, to a limit of 2,000 characters. localized_study__v.study_name__v
C.5.3 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value entered in the Patient Initials / ID field on the Case.

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name	Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - GP (`mrn_gp_value__v`) field has any value or is set to any Reason Omitted (`mrn_gp_reason_omitted__v`). Otherwise, this element is not transmitted.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - Specialist (`mrn_specialist_value__v`) field has any value or is set to any Reason Omitted (`mrn_specialist_reason_omitted__v`). Otherwise, this element is not transmitted.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - Hospital (`mrn_hospital_value__v`) field has any value or is set to any Reason Omitted (`mrn_hospital_reason_omitted__v`). Otherwise, this element is not transmitted.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - Investigation (`mrn_investigation_value__v`) field has any value or is set to any Reason Omitted (`mrn_investigation_reason_omitted__v`). Otherwise, this element is not transmitted.

D.2 Age Information

E2B Data Element Name	Populated Value
D.2.1 Date of Birth	This element is transmitted with nullFlavour `MSK` when the Case Date of Birth (`dob_idate__v`) field has the full date with year, month, and day, or is set to any Reason Omitted (`dob_reason_omitted__v`). Otherwise, this element is not transmitted.
D.2.2a Age at Time of Onset of Reaction / Event (number)	The value entered in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The value selected in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number)	The value entered in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit selected in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter)	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted.
D.3 Body Weight (kg)	The value entered in the Weight field on the Case.
D.4 Height (cm)	The value entered in the Height (normalized) field on the Case.
D.5 Sex	The option populated in the Gender field on the Case.
D.6 Last Menstrual Period Date	The date entered in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
D.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object.
D.7.1.r.5 Comments	Repeated for each Localized Case Medical History record related to the Japanese Localized Case. Mapped from the Comments field (`localized_case_medical_history__v.comments__v`), to a limit of 2,000 characters.
D.7.1.r.6 Family History	The value selected in the Family History field on the Case Medical History object.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Japan Localized Case, to a limit of 10,000 characters. localized_case__v.medical_history_text__v
D.7.3 Concomitant Therapies	Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.1 Name of Drug as Reported	Repeated for each Localized Case Drug History under the Japan Localized Case. Mapped from one of the following sources: The system first attempts to map this value from the Drug (Reported) field. localized_case_drug_history__v.name_reported__v If the Drug (Reported) field is blank, the system maps the Drug (Coded) field. localized_case_drug_history__v.product_name__v
D.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History record.
D.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History record.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History record.
D.8.r.5 End Date	The value entered in the End Date field on the Case Drug History record.
D.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code)	The value entered in the Reaction MedDRA field on the Case Drug History record.

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.1 Date of Death	The date entered in the Date of Death field on the Case.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text)	Repeated for each Localized Case Cause of Death under the Japan Localized Case. Mapped from the text entered in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v
D.9.3 Was Autopsy Done?	The value selected in the Autopsy field on the Case.
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code)	The MedDRA LLT coded on the Autopsy-Determined Case Cause of Death object.
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text)	Repeated for each Autopsy-Determined Localized Case Cause of Death under the Japan Localized Case. Mapped from the value in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
D.10.2.1 Date of Birth of Parent	The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case.
D.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
D.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
D.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
D.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
D.10.6 Sex of Parent	The value entered in the Gender field on the associated Parent-type Case.
D.10.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.3 Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.5 Comments	Repeated for each Localized Case Medical History from the Localized Case for the associated Parental-type Case. Mapped from the Comments field, to a limit of 2,000 characters. localized_case_medical_history__v.comments__v
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text entered in the Medical History Text field, to a limit of 10,000 characters, from the Localized Case for the associated Parental-type Case.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1 Name of Drug as Reported	Repeated for each Localized Case Drug History under a Parental-type Case related to the Japan Localized Case. Mapped from the value entered in the Name Reported field. localized_case_drug_history__v.name_reported__v
D.10.8.r.2a MPID Version Date/Number	The value entered in the MPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.5 End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.7b Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.

E.I Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) field on the Case Adverse Event. case_adverse_event__v.event_reported__v
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) - Language field on the Case Adverse Event. case_adverse_event__v.event_reported_language__v
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	Repeated for each Localized Case Adverse Event under the Japan Localized Case. Mapped from the text entered in the Event (Reported) field on the Case Adverse Event. localized_case_adverse_event__v.event_reported__v
E.i.2.1a MedDRA Version for Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code)	The value entered in the Event (MedDRA) field on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value selected in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name

Populated Value

E.i.3.2a Results in Death

Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2b Life Threatening

Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2c Caused / Prolonged Hospitalisation

Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2d Disabling / Incapacitating

Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2e Congenital Anomaly / Birth Defect

Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.

E.i.3.2f Other Medically Important Condition

Set to True when Other medically important condition is selected in the Seriousness field on the Case Adverse Event.

E.i.4 Date of Start of Reaction / Event

The date entered in the Onset field on the Case Adverse Event.

E.i.5 Date of End of Reaction / Event

The date entered in the Resolved field on the Case Adverse Event.

E.i.6a Duration of Reaction / Event (number)

The value entered in the Duration field on the Case Adverse Event.

E.i.6b Duration of Reaction / Event (unit)

The unit entered in the Duration (unit) field on the Case Adverse Event.

E.i.7 Outcome of Reaction / Event at the Time of Last Observation

The value selected in the Outcome field on the Case Adverse Event.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Recovered/Resolved	1 - Recovered/Resolved
2 - Recovering/Resolving	2 - Recovering/Resolving
3 - Not Recovered/Not Resolved/Ongoing	3 - Not Recovered/Not Resolved.Ongoing
4 - Recovered/Resolved with Sequelae	4 - Recovered/Resolved with Sequelae
5 - Fatal	5 - Fatal
0 - Unknown	0 - Unknown

E.i.8 Medical Confirmation by Healthcare Professional

E.i.9 Identification of the Country Where the Reaction / Event Occurred

The value entered in the Event Country field on the Case Adverse Event.

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

For PMDA, section F.r is repeated for each Case Test Result, in ascending order by date.

E2B Data Element Name	Populated Value
F.r.1 Test Date	The date entered in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The information entered in the Test Name (Reported) field on the Japan Localized Case Test Result. localized_case_test_result__v.name_reported__v
F.r.2.2a MedDRA Version for Test Name	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code)	The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code)	The value selected in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.3 Test Result (unit)	The unit selected in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Japan Localized Case Test Result. In accordance with ICH guidelines, the system adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element. localized_case_test_result__v.result_text__v
F.r.4 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.5 Normal High Value	The unit and value entered in the Normal High Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
F.r.6 Comments (free text)	The information entered in the Comments field on the Japan Localized Case Test Result. localized_case_test_result__v.comments__v
F.r.7 More Information Available	The value entered in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

The system transmits section G.k for all Local Reporting Details / Product Joins under the Local Reporting Details associated with the Transmission, ordered by Rank. If there are no Case Product Registrations (CPR) with a PMDA Rank, the system generates the entire PMDA E2B(R3) using ICH E2B(R3) mappings instead.

If some Local Reporting Details / Product Joins do not have a Rank assigned, the system transmits Local Reporting Details / Product Joins in the following order:

CPR with Drug Role = "Suspect"
Product with no CPR specified and Drug Role = "Suspect" – Company Products not registered in Japan
Product with no CPR specified and Drug Role = " Suspect" – External Product
CPR with Drug Role = "Interacting"
CPR with Drug Role = "Concomitant"
CPR without Drug Role
Product with no CPR specified – Company Products not registered in Japan
Product with no CPR specified – External Products

E2B Data Element Name

Populated Value

G.k.1 Characterisation of Drug Role

The value entered in the Drug Role field on the Case Product record.

G.k.2.4 Identification of the Country Where the Drug Was Obtained

The value entered in the Country Obtained field on the Case Product record.

G.k.2.5 Investigational Product Blinded

The value entered in the Blinded field on the Case Product record.

G.k.5a Cumulative Dose to First Reaction (number)

The value entered in the Cumulative Dose field on the Case Product record.

G.k.5b Cumulative Dose to First Reaction (unit)

The unit selected in the Cumulative Dose (unit) field on the Case Product record.

G.k.6a Gestation Period at Time of Exposure (number)

The value entered in the Gestation Exposure field on the Case Product record.

G.k.6b Gestation Period at Time of Exposure (unit)

The unit selected in the Gestation Exposure (unit) field on the Case Product record.

G.k.8 Action(s) Taken with Drug

The value selected in the Action Taken field on the Case Product record.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B R3 Code values.

Vault E2B Code	E2B R3 Code
1 - Drug Withdrawn	1 - Drug Withdrawn
2 - Dose Reduced	2 - Dose Reduced
3 - Dose Increased	3 - Dose Increased
4 - Dose Not Changed	4 - Dose Not Changed
0 - Unknown	0 - Unknown
9 - Not Applicable	9 - Not Applicable

G.k.10.r Additional Information on Drug (coded)

The value selected in the Additional Information field on the Case Product record.

G.k.11 Additional Information on Drug (free text)

The information entered in the Additional Information (text) field on the Localized Case Product record.

localized_case_product__v.additional_information_on_text__v

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.1.1a MPID Version Date / Number	The value entered in the MPID Version field on the Case Product record.
G.k.2.1.1b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Product record.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	For products assigned a PMDA Rank, the system maps data from the Case Product Registration: The system first attempts to map this value from the Local Product Code. case_product_registration__v.case_local_product_code__v If the Local Product Code is blank, the system then attempts to map the Clinical Compound Number. case_product_registration__v.clinical_compound_number__v If the Clinical Compound Number is also blank the system maps the Name. case_product_registration__v.name__v For Company and External Products without a PMDA Rank, the system maps data from the Localized Case Product: The system first attempts to map this value from the Local MPID. localized_case_product__v.local_mpid__v If the Local MPID is blank, the system then attempts to map the Product Name. localized_case_product__v.product_name__v If the Local MPID is also blank the system maps the Product (Reported). localized_case_product__v.product_reported__v

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name	For each Case Product Substance that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Substance, and then maps the substance name using the following logic: The system first attempts to map this value from the Local Product Code field. localized_case_product_substance__v.local_product_code__v If the Local Product Code is blank, the system then attempts to map the Name (Reported) field. localized_case_product_substance__v.name_reported__v If the Name (Reported) is also blank, then the system maps the Name (Reported) field on the Case Product Substance from the global Case. case_product_substance__v.name_reported__v
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value entered in the TermID Version field on the Case Product Substance.
G.k.2.3.r.2b Substance / Specified Substance TermID	The value entered in the TermID field on the Case Product Substance.
G.k.2.3.r.3a Strength (number)	The value entered in the Strength (Number) field on the Case Product Substance.
G.k.2.3.r.3b Strength (unit)	The unit selected in the Strength (Unit) field on the Case Product Substance.

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name	Populated Value
G.k.3.1 Authorisation / Application Number	This element is only transmitted for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Number field on the Case Product Registration. case_product_registration__v.registration_number__v
G.k.3.2 Country of Authorisation / Application	This element is only transmitted for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the 2-letter country code for the country selected in the Registration Country on the Case Product Registration. case_product_registration__v.registration_country__vr.abbreviation_2__v
G.k.3.3 Name of Holder / Applicant	This element is only transmitted for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Holder/Applicant on the Case Product Registration. case_product_registration__v.registration_mah__v

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.1a Dose (number)	The value entered in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit selected in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value entered in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit selected in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The information entered in the First Administration field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The information entered in the Last Administration field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The value entered in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit selected in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
G.k.4.r.8 Dosage Text	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Dosage, and then maps the Dose Text field. localized_case_product_dosage__v.dose_text__v
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system maps the Japan Localized Dose Form corresponding to the value selected in the Dose Form field. case_product_dosage__v.dose_form__v.localized_dose_form__v.e2b_code__v
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	The information entered in the Dose Form TermID Version field on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	The information entered in the Dose Form TermID field on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Dosage, and then maps the value from the Patient RoA field. localized_case_product_dosage__v.patient_adminroute_text__v
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	The information entered in the Patient RoA TermID Version field on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system maps the E2B code corresponding to the value selected in the Patient RoA field. case_product_dosage__v.patient_adminroute__vr.e2b_code__v
G.k.4.r.11.1 Parent Route of Administration (free text)	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Dosage, and then maps the Patient RoA Text field. localized_case_product_dosage__v.parent_adminroute_text__v
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	The information entered in the Parent RoA TermID Version field on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID	This element is transmitted for parent-child/fetus cases only. For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system maps the E2B code corresponding to the value selected the Parent RoA field. case_product_dosage__v.parent_adminroute__vr.e2b_code__v

G.k.7.r Indication for Use in Case

E2B Data Element Name	Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source	The text from the Name (Reported) field on the Japan Localized Case Product Indication. localized_case_product_indication__v.name_reported__v
G.k.7.r.2a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code)	The MedDRA LLT coded on the Case Product Indication.

G.k.9.i Drug-reaction(s) / Event(s) Matrix

E2B Data Element Name	Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed	The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)	The value entered in the First Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)	The unit selected in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)	The value entered in the Last Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)	The unit selected in the Last Dose Latency (unit) field on the Case Assessment.
G.k.9.i.4 Did Reaction Recur on Re-administration?	The appropriate value is populated, based on the option selected in the Reaction Recurrence field on the Case Assessment: `1`: yes - yes (rechallenge was done, reaction reccurred) `2`: yes - no (rechallenge was done, reaction did not recur) `3`: yes - unk (rechallenge was done, outcome unknown) `4`: no - n/a (no rechallenge was done, recurrance is not applicable)

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1 Source of Assessment	For the option selected in the Source Type on the Case Assessment, the system finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name. source_type__v.localized_controlled_vocabulary__v.name__v
G.k.9.i.2.r.2 Method of Assessment	For the option selected in the Method of Assessment on the Case Assessment, the system finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name. method_of_assessment__v.localized_controlled_vocabulary__v.name__v
G.k.9.i.2.r.3 Result of Assessment	The system finds the record Name of the Assessment Result (Override) Controlled Vocabulary. `assessment_result_override__v.localized_controlled_vocabulary__v.name__v` Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault. Note There is a limitation with the Assessment Result (Override) Controlled Vocabulary where the system will find the English record Name instead of the Japan Localized record. This limitation will be addressed in a future release. If the Assessment Result (Override) is not available, the system finds the corresponding Japan Localized Controlled Vocabulary for the Assessment Result value on the Case Assessment and maps the record Name. `assessment_result__v.localized_controlled_vocabulary__v.name__v`

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative Text field on the Japan Localized Case, to a limit of 100,000 characters. localized_case__v.narrative_document__v
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Japan Localized Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The system selects the Case Comment that matches the Local Reporting Details of the Transmission if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Company Comments (`companys_comments_v`) The Case Comment has Local Reporting Details specified If there is no match but there is a Comment with no Local Reporting Details specified, the system selects that Comment. The H.4 Sender’s Comments field is then mapped to the Comments Text of the selected Case Comment. localized_case_comment__v.comments_text__v

H.3.r Sender's Diagnosis

E2B Data Element Name	Populated Value
H.3.r.1a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
H.3.r.1b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)	The MedDRA LLT coded on the Case Diagnosis.

Section J

E2B Data Element Name	Populated Value
J2.1a PMDA Reporting Category	The E2B code corresponding to the PMDA Reporting Category of the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v. pmda_reporting_category__v.controlled_vocabulary__v.e2b_code__v
J2.1b PMDA Identification Number	The value from the Destination Case ID field from the Local Reporting Details for the Transmission. transmission__v.local_reporting_details__v.destination_case_id__v
J2.2.1 Day 0 of Reporting Timeframe	The date from the Local Awareness Date on the Japan Localized Case, in the format `YYYYMMDD`. localized_case__v.local_awareness_date__v
J2.2.2 Comments on Initial Date for Reporting	This field is mapped from the Comments Text field if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Receipt Date Comments (`receipt_date_comments__v`) The Local Reporting Details matches those of the Transmission Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment’s Label matches the Receipt Date Comments. localized_case_comment__v.comments_text__v
J2.3 Flag for Immediate Report	If the Immediate Report Type field is set to System (E2B) (`system_e2b__v`) on the Local Reporting Details related to the Transmission, this element is transmitted with `1`. transmission__v.local_reporting_details__v.immediate_report_type__v
J2.4.k License Category of New Drug	Repeated with the E2B Code for the Registration Type on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.registration_type_cv__v.e2b_code__v
J2.5.k Classification of OTC drugs	Repeated with the E2B Code for the OTC Drug Classification on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_classification__v.e2b_code__v
J2.6.k Obtaining channels for OTC drugs	Repeated with the E2B Code or nullflavor for the OTC Drug Channel on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_channel__v.e2b_code__v
J2.7.1 Completion flag	The E2B Code for the Completeness on the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v.completeness__v.e2b_code__v
J2.7.2 Comments on Incompletion	This field is mapped from the Comments Text field if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Comments on Completeness (`comments_on_completeness_v`) The Local Reporting Details matches those of the Transmission Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment’s Label matches the Receipt Date Comments. localized_case_comment__v.comments_text__v
J2.8.1 Downgrade Report	If the Downgraded field is set to Yes on this Transmission, this element is transmitted with `1`. transmission__v.downgraded__v
J2.8.2 Reason for Downgrading Report	When J2.8.1 is transmitted with `1`, this field is mapped from the Comments Text field if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Downgrade Reason (`downgrade_reason__v`) The Local Reporting Details matches those of the Transmission localized_case_comment__v.comments_text__v
J2.9 Retrospective analysis of infections	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Retrospective analysis of infections (`retrospective_analysis_of_infections__v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.10 Action to be taken	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Action to be Taken (`future_actions_v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.11 Other references	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Other References (`other_references__v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.12 Clinical Compound Number (CCN)	For investigational products only. This field is mapped to the Clinical Compound Number of the Primary Case Product Registration of the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v. primary_case_product_registration_v.clinical_compound_number_v
J2.14.i Expectedness	This is mapped from the value in the Expected field on each Localized Case Assessment related to the primary PMDA product under the Japan Localized Case: If Yes, `2` is transmitted If No, `1` is transmitted Otherwise, this element is not transmitted This element is repeated and placed under the appropriate E.i section, based on product and adverse event combination. If there are multiple products assigned a PMDA Rank and transmitted in section G.k, this element is only transmitted if the primary (Rank 1) PMDA product is the only suspect product (Drug Role = Suspect). localized_case_assessment__v.expected__v
J2.15.r Country of publication	The 2-letter country code for the Publication Country on each document attached to the Case with the document type of Case > Source > Literature. publication_country__v.abbreviation_2__v
J2.16 Overview of the report	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Report Overview (`report_overview__v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.17.r Classification of trial/research	For each document identified in J2.15.r, mapped from the E2B Code for the Literature Classification on each document. literature_classification__v.e2b_code__v

Section J2.13.r

This section is only populated when element J2.12 is transmitted.

This section is repeated for each Study with an associated Case Product Registration that has the same Clinical Compound Number as the CCN transmitted in J2.12. For each matching Study, the system maps elements J2.13.r.1 to J2.13.r.4 using the corresponding Japan Localized Study.

E2B Data Element Name	Populated Value
J2.13.r.1 Number of CTN	The value from the Number of Clinical Trial Notifications field on the Japan Localized Study. localized_study__v.number_of_clinical_trial_notifications__v
J2.13.r.2 Study indications	The value from the Target Disease field on the Japan Localized Study. localized_study__v.target_disease__v
J2.13.r.3 Development phase	The E2B Code corresponding to the value from the Development Phase field on the global Study related to the Japan Localized Study. localized_study__v.study__v.development_phase__v.e2b_code__v
J2.13.r.4 Existence of subjects	The value from the Existence of Subjects field on the Japan Localized Study: If Yes, `true` is transmitted If No, `false` is transmitted Otherwise, this element is not transmitted localized_study__v.existence_of_subjects__v

Section J2.18

Vault Safety uses the Receiver Person from the Transmission Profile to map to elements J2.18.2 to J2.18.4.

E2B Data Element Name	Populated Value
J2.18.1 Recipient organization name	Mapped using the Transmission for the Japan Localized Case. The system finds the Japan Localized Organization corresponding to the Destination on the Transmission Profile used for the Transmission. From the Japan Localized Organization, the system maps the Official Name. localized_organization__v.official_name__v
J2.18.2 Recipient title	The Title field on the Receiver Person of the Transmission Profile. person__sys.title__v
J2.18.3 Recipient's family name	The Last Name field on the Receiver Person of the Transmission Profile. If “Last Name” is selected in the `exclude_from_receiver_block__v` field on the associated Receiver Person, this element is omitted. person__sys.last_name__sys
J2.18.4 Recipient's given name	The First Name field on the Receiver Person of the Transmission Profile. If “First Name” is selected in the `exclude_from_receiver_block__v` field on the associated Receiver Person, this element is omitted. person__sys.first_name__sys

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted. The time is converted to Japan Standard Time (JST) and transmitted in the format `CCYYMMDDhhmmss+0900`.

N.2.r ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	For PMDA, the system generates this value during E2B generation using the following fields: `(case_version__v.reporter_country__v.abbreviation_2__v) (transmission_profile__v.origin_id__v) (local_reporting_details__v.report_uid__v)` For example: JP-VertBio-000001AB Note For the system to generate this value, all three fields must be populated. If any field is blank, this data element is not exported. PMDA requires that when multiple ICSRs are submitted from a single Case, N.2.r.1 and C.1.1 must be different for each ICSR. To achieve this, Vault Safety adds logic to append suffix (AA-ZZ) to the existing UID generation logic to make it unique per submission. The generated UID is stored in the Report UID field of the Local Reporting Details (`local_reporting_details__v.report_uid__v`) record.
N.2.r.4 Date of Message Creation	The exact date and time when the report was generated, in the format `CCYYMMDDhhmmss+0900`. The time is converted to Japan Standard Time (JST).

C.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier	For PMDA, the system generates this value during E2B generation using the following fields: `(case_version__v.reporter_country__v.abbreviation_2__v) (transmission_profile__v.origin_id__v) (local_reporting_details__v.report_uid_v)` For example: JP-VertBio-000001AB Note For the system to generate this value, all three fields must be populated. If any field is blank, this data element is exported with no value populated. See N.2.r.1 for unique report UID generation.
C.1.2 Date of Creation	The exact date and time when the report was generated, in the format `CCYYMMDDhhmmss+0900`. The time is converted to Japan Standard Time (JST).
C.1.4 Date Report Was First Received from Source	For initial Cases, the date entered in the Local Initial Receipt Date field on the Localized Case. If blank, the the date in the Receipt Date field on the Global Case is exported. For Follow-Up Cases, the date entered in the Local Initial Receipt Date field on the Localized Case. If blank, the date in the Initial Receipt Date field on the Global Case is exported.
C.1.5 Date of Most Recent Information for This Report	The date entered in the Local New Info Date field on the Localized Case. If blank, the date in the New Info Date field from the Global Case is exported.

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1.r.1 Documents Held by Sender	The system first finds any file attached to the Case with the document type of Case > Source > Attachment. Then, the system retrieves the corresponding Japanese Localized Case Document and populates this element with the Attachment Description, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank. localized_case_document__v.attachment_description__v
C.1.6.1.r.2 Included Documents	If any documents are attached to the Case with the document type of Case > Source > Attachment, they will be encoded.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value entered in the Source field on each Localized Case Identifier object under the Japanese Localized Case. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank. localized_case_identifier__v.source__v

C.2.r Primary Source(s) of Information

E2B Data Element Name	Populated Value
C.2.r.3 Reporter’s Country Code	The ISO code populated in the Country field on the primary Reporter-type Case Contact. This field is only transmitted if C.2.r.5 is set to `1` (Primary Source) for the corresponding Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the E2B code of `5` is mapped.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name	Populated Value
C.3.2 Sender's Organisation	The Organization selected in the Origin field on the PMDA Transmission Profile. transmission_profile__v.origin_transmission_id__v

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The system first finds any Case attachments with the document type of Case > Source > Literature. Then, the system retrieves the corresponding Japanese Localized Case Document and populates this element with the Reference, to a limit of 500 characters. localized_case_document__v.reference__v

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.2 Study Name	The values entered in the Study Name and Study Name (Continued) fields on the associated Japanese Localized Case, to a limit of 2,000 characters. localized_study__v.study_name__v

D.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number

E2B Data Element Name	Populated Value
D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - GP (`mrn_gp_value__v`) field has any value or is set to any Reason Omitted (`mrn_gp_reason_omitted__v`). Otherwise, this element is not transmitted.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - Specialist (`mrn_specialist_value__v`) field has any value or is set to any Reason Omitted (`mrn_specialist_reason_omitted__v`). Otherwise, this element is not transmitted.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - Hospital (`mrn_hospital_value__v`) field has any value or is set to any Reason Omitted (`mrn_hospital_reason_omitted__v`). Otherwise, this element is not transmitted.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)	This element is transmitted with nullFlavour `MSK` when the Case MRN - Investigation (`mrn_investigation_value__v`) field has any value or is set to any Reason Omitted (`mrn_investigation_reason_omitted__v`). Otherwise, this element is not transmitted.

D.2 Age Information

E2B Data Element Name	Populated Value
D.2.1 Date of Birth	This element is transmitted with nullFlavour `MSK` when the Case Date of Birth (`dob_idate__v`) field has the full date with year, month, and day, or is set to any Reason Omitted (`dob_reason_omitted__v`). Otherwise, this element is not transmitted.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.5 Comments	Repeated for each Localized Case Medical History record related to the Japanese Localized Case. Mapped from the Comments field (`localized_case_medical_history__v.comments__v`), to a limit of 2,000 characters.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Japan Localized Case, to a limit of 10,000 characters. localized_case__v.medical_history_text__v

D.8.r Relevant Past Drug History

E2B Data Element Name	Populated Value
D.8.r.1 Name of Drug as Reported	Repeated for each Localized Case Drug History under the Japan Localized Case. Mapped from one of the following sources: The system first attempts to map this value from the Drug (Reported) field. localized_case_drug_history__v.name_reported__v If the Drug (Reported) field is blank, the system maps the Drug (Coded) field. localized_case_drug_history__v.product_name__v

D.9 In case of Death

E2B Data Element Name	Populated Value
D.9.2.r.2 Reported Cause(s) of Death (free text)	Repeated for each Localized Case Cause of Death under the Japan Localized Case. Mapped from the text entered in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text)	Repeated for each Autopsy-Determined Localized Case Cause of Death under the Japan Localized Case. Mapped from the value in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v

D.10 For a Parent-child / Foetus Report, Information Concerning the Parent

E2B Data Element Name	Populated Value
D.10.7.1.r.5 Comments	Repeated for each Localized Case Medical History from the Localized Case for the associated Parental-type Case. Mapped from the Comments field, to a limit of 2,000 characters. localized_case_medical_history__v.comments__v
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text entered in the Medical History Text field, to a limit of 10,000 characters, from the Localized Case for the associated Parental-type Case.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
D.10.8.r.1 Name of Drug as Reported	Repeated for each Localized Case Drug History under a Parental-type Case related to the Japan Localized Case. Mapped from the value entered in the Name Reported field. localized_case_drug_history__v.name_reported__v

E.I Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) field on the Case Adverse Event. case_adverse_event__v.event_reported__v
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) - Language field on the Case Adverse Event. case_adverse_event__v.event_reported_language__v
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	Repeated for each Localized Case Adverse Event under the Japan Localized Case. Mapped from the text entered in the Event (Reported) field on the Case Adverse Event. localized_case_adverse_event__v.event_reported__v

F.r Results of Tests and Procedures Relevant to the Investigation of the Patient

For PMDA, section F.r is repeated for each Case Test Result, in ascending order by date.

E2B Data Element Name	Populated Value
F.r.2.1 Test Name (free text)	The information entered in the Test Name (Reported) field on the Japan Localized Case Test Result. localized_case_test_result__v.name_reported__v
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Japan Localized Case Test Result. In accordance with ICH guidelines, the system adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element. localized_case_test_result__v.result_text__v
F.r.6 Comments (free text)	The information entered in the Comments field on the Japan Localized Case Test Result. localized_case_test_result__v.comments__v

G.k Drug(s) Information

If some Local Reporting Details / Product Joins do not have a Rank assigned, the system transmits Local Reporting Details / Product Joins in the following order:

CPR with Drug Role = "Suspect"
Product with no CPR specified and Drug Role = "Suspect" – Company Products not registered in Japan
Product with no CPR specified and Drug Role = " Suspect" – External Product
CPR with Drug Role = "Interacting"
CPR with Drug Role = "Concomitant"
CPR without Drug Role
Product with no CPR specified – Company Products not registered in Japan
Product with no CPR specified – External Products

E2B Data Element Name	Populated Value
G.k.11 Additional Information on Drug (free text)	The information entered in the Additional Information (text) field on the Localized Case Product record. localized_case_product__v.additional_information_on_text__v

G.k.2 Drug Identification

E2B Data Element Name	Populated Value
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	For products assigned a PMDA Rank, the system maps data from the Case Product Registration: The system first attempts to map this value from the Local Product Code. case_product_registration__v.case_local_product_code__v If the Local Product Code is blank, the system then attempts to map the Clinical Compound Number. case_product_registration__v.clinical_compound_number__v If the Clinical Compound Number is also blank the system maps the Name. case_product_registration__v.name__v For Company and External Products without a PMDA Rank, the system maps data from the Localized Case Product: The system first attempts to map this value from the Local MPID. localized_case_product__v.local_mpid__v If the Local MPID is blank, the system then attempts to map the Product Name. localized_case_product__v.product_name__v If the Local MPID is also blank the system maps the Product (Reported). localized_case_product__v.product_reported__v

G.k.2.3.r Substance / Specified Substance Identifier and Strength

E2B Data Element Name	Populated Value
G.k.2.3.r.1 Substance / Specified Substance Name	For each Case Product Substance that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Substance, and then maps the substance name using the following logic: The system first attempts to map this value from the Local Product Code field. localized_case_product_substance__v.local_product_code__v If the Local Product Code is blank, the system then attempts to map the Name (Reported) field. localized_case_product_substance__v.name_reported__v If the Name (Reported) is also blank, then the system maps the Name (Reported) field on the Case Product Substance from the global Case. case_product_substance__v.name_reported__v

G.k.3 Holder and Authorisation / Application Number of Drug

E2B Data Element Name	Populated Value
G.k.3.1 Authorisation / Application Number	This element is only transmitted for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Number field on the Case Product Registration. case_product_registration__v.registration_number__v
G.k.3.2 Country of Authorisation / Application	This element is only transmitted for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the 2-letter country code for the country selected in the Registration Country on the Case Product Registration. case_product_registration__v.registration_country__vr.abbreviation_2__v
G.k.3.3 Name of Holder / Applicant	This element is only transmitted for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Holder/Applicant on the Case Product Registration. case_product_registration__v.registration_mah__v

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
G.k.4.r.8 Dosage Text	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Dosage, and then maps the Dose Text field. localized_case_product_dosage__v.dose_text__v
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system maps the Japan Localized Dose Form corresponding to the value selected in the Dose Form field. case_product_dosage__v.dose_form__v.localized_dose_form__v.e2b_code__v
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	The information entered in the Dose Form TermID Version field on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	The information entered in the Dose Form TermID field on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Dosage, and then maps the value from the Patient RoA field. localized_case_product_dosage__v.patient_adminroute_text__v
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	The information entered in the Patient RoA TermID Version field on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system maps the E2B code corresponding to the value selected in the Patient RoA field. case_product_dosage__v.patient_adminroute__vr.e2b_code__v
G.k.4.r.11.1 Parent Route of Administration (free text)	For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system finds the corresponding Japan Localized Case Product Dosage, and then maps the Patient RoA Text field. localized_case_product_dosage__v.parent_adminroute_text__v
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	The information entered in the Parent RoA TermID Version field on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID	This element is transmitted for parent-child/fetus cases only. For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, the system maps the E2B code corresponding to the value selected the Parent RoA field. case_product_dosage__v.parent_adminroute__vr.e2b_code__v

G.k.7.r Indication for Use in Case

E2B Data Element Name	Populated Value
G.k.7.r.1 Indication as Reported by the Primary Source	The text from the Name (Reported) field on the Japan Localized Case Product Indication. localized_case_product_indication__v.name_reported__v

G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) / Event(s)

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1 Source of Assessment	For the option selected in the Source Type on the Case Assessment, the system finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name. source_type__v.localized_controlled_vocabulary__v.name__v
G.k.9.i.2.r.2 Method of Assessment	For the option selected in the Method of Assessment on the Case Assessment, the system finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name. method_of_assessment__v.localized_controlled_vocabulary__v.name__v
G.k.9.i.2.r.3 Result of Assessment	The system finds the record Name of the Assessment Result (Override) Controlled Vocabulary. `assessment_result_override__v.localized_controlled_vocabulary__v.name__v` Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault. Note There is a limitation with the Assessment Result (Override) Controlled Vocabulary where the system will find the English record Name instead of the Japan Localized record. This limitation will be addressed in a future release. If the Assessment Result (Override) is not available, the system finds the corresponding Japan Localized Controlled Vocabulary for the Assessment Result value on the Case Assessment and maps the record Name. `assessment_result__v.localized_controlled_vocabulary__v.name__v`

H Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text from the Narrative Text field on the Japan Localized Case, to a limit of 100,000 characters. localized_case__v.narrative_document__v
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Japan Localized Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The system selects the Case Comment that matches the Local Reporting Details of the Transmission if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Company Comments (`companys_comments_v`) The Case Comment has Local Reporting Details specified If there is no match but there is a Comment with no Local Reporting Details specified, the system selects that Comment. The H.4 Sender’s Comments field is then mapped to the Comments Text of the selected Case Comment. localized_case_comment__v.comments_text__v

Section J

E2B Data Element Name	Populated Value
J2.1a PMDA Reporting Category	The E2B code corresponding to the PMDA Reporting Category of the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v. pmda_reporting_category__v.controlled_vocabulary__v.e2b_code__v
J2.1b PMDA Identification Number	The value from the Destination Case ID field from the Local Reporting Details for the Transmission. transmission__v.local_reporting_details__v.destination_case_id__v
J2.2.1 Day 0 of Reporting Timeframe	The date from the Local Awareness Date on the Japan Localized Case, in the format `YYYYMMDD`. localized_case__v.local_awareness_date__v
J2.2.2 Comments on Initial Date for Reporting	This field is mapped from the Comments Text field if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Receipt Date Comments (`receipt_date_comments__v`) The Local Reporting Details matches those of the Transmission Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment’s Label matches the Receipt Date Comments. localized_case_comment__v.comments_text__v
J2.3 Flag for Immediate Report	If the Immediate Report Type field is set to System (E2B) (`system_e2b__v`) on the Local Reporting Details related to the Transmission, this element is transmitted with `1`. transmission__v.local_reporting_details__v.immediate_report_type__v
J2.4.k License Category of New Drug	Repeated with the E2B Code for the Registration Type on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.registration_type_cv__v.e2b_code__v
J2.5.k Classification of OTC drugs	Repeated with the E2B Code for the OTC Drug Classification on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_classification__v.e2b_code__v
J2.6.k Obtaining channels for OTC drugs	Repeated with the E2B Code or nullflavor for the OTC Drug Channel on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_channel__v.e2b_code__v
J2.7.1 Completion flag	The E2B Code for the Completeness on the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v.completeness__v.e2b_code__v
J2.7.2 Comments on Incompletion	This field is mapped from the Comments Text field if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Comments on Completeness (`comments_on_completeness_v`) The Local Reporting Details matches those of the Transmission Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment’s Label matches the Receipt Date Comments. localized_case_comment__v.comments_text__v
J2.8.1 Downgrade Report	If the Downgraded field is set to Yes on this Transmission, this element is transmitted with `1`. transmission__v.downgraded__v
J2.8.2 Reason for Downgrading Report	When J2.8.1 is transmitted with `1`, this field is mapped from the Comments Text field if: The Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Downgrade Reason (`downgrade_reason__v`) The Local Reporting Details matches those of the Transmission localized_case_comment__v.comments_text__v
J2.9 Retrospective analysis of infections	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Retrospective analysis of infections (`retrospective_analysis_of_infections__v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.10 Action to be taken	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Action to be Taken (`future_actions_v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.11 Other references	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Other References (`other_references__v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.12 Clinical Compound Number (CCN)	For investigational products only. This field is mapped to the Clinical Compound Number of the Primary Case Product Registration of the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v. primary_case_product_registration_v.clinical_compound_number_v
J2.14.i Expectedness	This is mapped from the value in the Expected field on each Localized Case Assessment related to the primary PMDA product under the Japan Localized Case: If Yes, `2` is transmitted If No, `1` is transmitted Otherwise, this element is not transmitted This element is repeated and placed under the appropriate E.i section, based on product and adverse event combination. If there are multiple products assigned a PMDA Rank and transmitted in section G.k, this element is only transmitted if the primary (Rank 1) PMDA product is the only suspect product (Drug Role = Suspect). localized_case_assessment__v.expected__v
J2.15.r Country of publication	The 2-letter country code for the Publication Country on each document attached to the Case with the document type of Case > Source > Literature. publication_country__v.abbreviation_2__v
J2.16 Overview of the report	If the Japan Localized Case contains a Localized Case Comment where the Comments Label (`comments_label__v`) field is set to Report Overview (`report_overview__v`) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.17.r Classification of trial/research	For each document identified in J2.15.r, mapped from the E2B Code for the Literature Classification on each document. literature_classification__v.e2b_code__v

Section J2.13.r

This section is only populated when element J2.12 is transmitted.

E2B Data Element Name	Populated Value
J2.13.r.1 Number of CTN	The value from the Number of Clinical Trial Notifications field on the Japan Localized Study. localized_study__v.number_of_clinical_trial_notifications__v
J2.13.r.2 Study indications	The value from the Target Disease field on the Japan Localized Study. localized_study__v.target_disease__v
J2.13.r.3 Development phase	The E2B Code corresponding to the value from the Development Phase field on the global Study related to the Japan Localized Study. localized_study__v.study__v.development_phase__v.e2b_code__v
J2.13.r.4 Existence of subjects	The value from the Existence of Subjects field on the Japan Localized Study: If Yes, `true` is transmitted If No, `false` is transmitted Otherwise, this element is not transmitted localized_study__v.existence_of_subjects__v

Section J2.18

Vault Safety uses the Receiver Person from the Transmission Profile to map to elements J2.18.2 to J2.18.4.

E2B Data Element Name	Populated Value
J2.18.1 Recipient organization name	Mapped using the Transmission for the Japan Localized Case. The system finds the Japan Localized Organization corresponding to the Destination on the Transmission Profile used for the Transmission. From the Japan Localized Organization, the system maps the Official Name. localized_organization__v.official_name__v
J2.18.2 Recipient title	The Title field on the Receiver Person of the Transmission Profile. person__sys.title__v
J2.18.3 Recipient's family name	The Last Name field on the Receiver Person of the Transmission Profile. If “Last Name” is selected in the `exclude_from_receiver_block__v` field on the associated Receiver Person, this element is omitted. person__sys.last_name__sys
J2.18.4 Recipient's given name	The First Name field on the Receiver Person of the Transmission Profile. If “First Name” is selected in the `exclude_from_receiver_block__v` field on the associated Receiver Person, this element is omitted. person__sys.first_name__sys

ICH E2B(R2) Mapping

M.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
M.1.1 Types of Message in Batch	For FDA and ICH E2B R2 exports, this element is always set to `1` for ICH ICSR.
M.1.2 Message Format Version	Set to default value `2.1` for an ICSR, or `1.0` for an acknowledgment.
M.1.3 Message Format Release	For FDA and ICH E2B R2 exports, this element is set to `1`.
M.1.4 Batch Number	The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
M.1.5 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
M.1.6 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
M.1.7b Date of Batch Transmission	Date and time when the report was generated or Transmitted, calculated with full precision down to the second.

ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.4 Date of Message Creation	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

A Administrative and Identification Numbers

A.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
A.1.0.1 Sender's (case) Safety Report Unique Identifier	The value entered in the UID field on the Case Number object is populated in this element. Also, if the Safety Report Version field is populated on the Transmission (Submission or Distribution), then the <`safetyreportversion`> tag is populated with the text entered in the field.
A.1.1 Reporter's Country Code	The ISO code populated in the Country field on the Reporter-type Case Contact.
A.1.2 Identification of the Country Where the Reaction / Event Occurred	The value entered in the Event Country field on the primary Case Adverse Event.
A.1.3b Date of Transmission	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.
A.1.4 Type of Report	The appropriate value is populated, based on the option selected in the Report Type field on the Case `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
A.1.5.1 Serious	Set to `1` (Yes) if there is at least one Case Adverse Event with seriousness criteria.
A.1.5.2 Seriousness Criteria	Populated with seriousness tags corresponding to the criteria selected in the Seriousness field across all Case Adverse Events. A seriousness criteria tag is set to `1` (Yes) if there is at least one Case Adverse Event with that seriousness criteria.
A.1.6 Date Report Was First Received from Source	For initial Cases, the date entered in the Receipt Date field on the Case. For Follow-Up Cases, the date entered in the Initial Receipt Date field on the Case.
A.1.7 Date of Most Recent Information for This Report	The date entered in the New Info Date field on the Case.
A.1.8.1 Are Additional Documents Available	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment with the Retransmit field set to Yes.
A.1.8.2 Documents Held by Sender	The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment, to a limit of 2,000 characters.
A.1.9 Does this case fulfill the local criteria for an expedited report	If the Local Expedited Criteria (`case_expedited__v`) field on the Transmission (Submission or Distribution) record has a value, the system uses this value. If this field is not specified on the Transmission, the system looks at the Expedited field on the Case. If the value is Yes, this element is populated with `1` (expedited). Otherwise, this element is populated with `2` (non-expedited).
A.1.10.1 Regulatory authority's case report number	The value entered in the Worldwide UID field on the Case Number object.
A.1.10.2 Other sender's case report number	The value entered in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
A.1.11 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case.
A.1.11.1 Source(s) of the Case Identifier	The value entered in the Source field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
A.1.11.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
A.1.12 Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
A.1.12 Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
A.1.13 Report Nullification / Amendment	Set to `1` when Nullification is selected in the Reason field on the Transmission.
A.1.13.1 Reason for Nullification / Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.
A.1.14 Medical Confirmation by Healthcare Professional	Populated based on the value in the HCP Confirmed field on the Case Adverse Event. This field is only transmitted when the Qualification field on the primary (Rank 1) Reporter-type Case Contact does not designate a health professional. That is, the Qualification Controlled Vocabulary does not correspond to E2B codes 1, 2, or 3.

A.2 Primary Source(s) of Information

E2B Data Element Name	Populated Value
A.2.1.1a Reporter's Title	The value entered in the Title field on a Reporter-type Case Contact.
A.2.1.1b Reporter's Given Name	The value entered in the First Name field on a Reporter-type Case Contact.
A.2.1.1c Reporter's Middle Name	The value entered in the Middle Name field on a Reporter-type Case Contact.
A.2.1.1d Reporter's Family Name	The value entered in the Last Name field on a Reporter-type Case Contact.
A.2.1.2a Reporter's Organisation	The value entered in the Organization field on a Reporter-type Case Contact.
A.2.1.2b Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
A.2.1.2c Reporter's Street	The value entered in the Street field on a Reporter-type Case Contact.
A.2.1.2d Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
A.2.1.2e Reporter's State or Province	The value entered in the State/Province field on a Reporter-type Case Contact.
A.2.1.2f Reporter's Postcode	The value entered in the Postal Code/Zip Code field on a Reporter-type Case Contact.
A.2.1.3 Reporter's Country Code	The ISO code populated in the Country field on a Reporter-type Case Contact.
A.2.1.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact.

A.3 Information on Sender and Reciever of Case Safety Report

E2B Data Element Name	Populated Value
A.3.1.1 Sender Type	The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Sender Type from the Organization on the Case.
A.3.1.2 Sender's Organisation	The value entered in the Organisation field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Organization on the Case.
A.3.1.3a Sender's Department	The value entered in the Department field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3b Sender's Title	The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3c Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3d Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3e Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4a Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4b Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4c Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4d Sender's Postcode	The value entered in the Postal Code / Zip Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4e Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4f Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4i Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4 Sender's E-mail Address	The value entered in the Email field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.2.2 Literature Reference(s)	The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.
A.2.3.1 Study Name	For FDA and ICH E2B R2, the values entered in the Study Name and Study Name (Continued) fields on the associated Study, to a limit of 2,000 characters.
A.2.3.2 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
A.2.3.3 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type (`product_usage_reason__v`) field on the Case.
A.3.2.1 Receiver Type	The option selected in the Receiver Type field of the Receiver Person record on the Transmission Profile record. If a Receiver Person is not specified, the system maps the Sender Type from the Destination Organization on the Transmission Profile. Per E2B(R2) guidelines, only the following values are mapped: `1`: Pharmaceutical company `2`: Regulatory authority `4`: Regional pharmacovigilance center `5`: WHO collaborating center for international drug monitoring
A.3.2.2a Receiver's Organisation	The value entered in the Organization field of the Receiver Person record on the Transmission Profile record. If a Receiver Person is not specified on the Transmission Profile, the system maps the value in the Destination ID field on the Transmission Profile.
A.3.2.2b Receiver's Department	The value entered in the Department field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2c Receiver's Title	The value entered in the Title field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2d Receiver's Given Name	The value entered in the First Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2e Receiver's Middle Name	The value entered in the Middle Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2f Receiver's Family Name	The value entered in the Last Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3a Receiver's Street Address	The value entered in the Street field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3b Receiver's City	The value entered in the City field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3c Receiver's State or Province	The value entered in the State / Province field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3d Receiver's Postcode	The value entered in the Postal Code / Zip Code field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3e Receiver's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3f Receiver's Telephone	The value entered in the Telephone field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3g Receiver's Telephone Extension	The value entered in the Telephone Extension field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3h Receiver's Telephone Country	The value entered in the Telephone Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3i Receiver's Fax	The value entered in the Fax field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3j Receiver's Fax Extension	The value entered in the Fax Extension field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3k Receiver's Fax Country	The value entered in the Fax Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3l Receiver's E-mail Address	The value entered in the Email field in the Person record associated with the Receiver Person on the Transmission Profile record.

B Information on the Case

B.1 Patient Characteristics

E2B Data Element Name	Populated Value
B.1.1 Patient initials	The value entered in the Patient Initials / ID field on the Case.
B.1.1.1a GP medical record number	The value entered in the MRN - GP field on the Case.
B.1.1.1b Specialist record number	The value entered in the MRN - Specialist field on the Case.
B.1.1.1c Hospital record number	The value entered in the MRN - Hospital field on the Case.
B.1.1.1d Investigation number	The value entered in the MRN - Investigation field on the Case.
B.1.2.1 Date of birth	The date entered in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
B.1.2.2a Age at time of onset of reaction/event (number)	The value entered in the Age field on the Case. In accordance with ICH guidelines, this element is only transmitted when the Patient Date of Birth (B.1.2.1) is not transmitted.
B.1.2.2b Age at time of onset of reaction/event (unit)	The value selected in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is only transmitted when the Patient Date of Birth (B.1.2.1) is not transmitted.
B.1.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (value)	The value entered in the Gestation field on the Case.
B.1.2.2.1b Gestation Period When Reaction / Event Was Observed in the Foetus (unit)	The unit selected in the Gestation (unit) field on the Case.
B.1.2.3 Patient age group	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (B.1.2.1) and Age at Onset (B.1.2.2) are not transmitted.
B.1.3 Body Weight (kg)	The value entered in the Weight field on the Case.
B.1.4 Height (cm)	The value entered in the Height (normalized) field on the Case.
B.1.5 Sex	The option populated in the Gender field on the Case.
B.1.6 Last menstrual period date	The date entered in the Last Menstrual field on the Case.
B.1.7.1a.1 MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.7.1a.2 Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
B.1.7.1c Start Date	The date entered in the Start Date field on the Case Medical History object.
B.1.7.1d Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
B.1.7.1f End Date	The date entered in the End Date field on the Case Medical History object.
B.1.7.1g Comments	The text entered in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
Family history	The value selected in the Family History field on the Case Medical History object.
B.1.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Case, to a limit of 10,000 characters.
B.1.8a Name of Drug as Reported	The value entered in the Name Reported field on the Case Drug History Object.
B.1.8c Start date	The date entered in the Start Date field on the Case Drug History Object.
B.1.8e End Date	The value entered in the End Date field on the Case Drug History Object.
B.1.8f.1 MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.8f.2 Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History Object.
B.1.8g.1 MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.8g.2 Reaction (MedDRA code)	The value entered in the Reaction MedDRA field on the Case Drug History Object.
B.1.9.1 Date of Death	The date entered in the Date of Death field on the Case.
B.1.9.2a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.9.2b Reported Cause(s) of Death (MedDRA code)	This field is exported from one of the following sources from the Reported Case Cause of Death record, ordered by priority: If the Cause of Death (LLT) (`name_meddra__v`) field is coded, the MedDRA code is exported. If a coded term is unavailable, the Cause of Death (Reported) (`name_reported__v`) field is exported.
B.1.9.3 Was Autopsy Done?	The value selected in the Autopsy field on the Case.
B.1.9.4a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.9.4b Autopsy-determined Cause(s) of Death (MedDRA code)	This field is exported from one of the following sources from the Autopsy-Determined Case Cause of Death record, ordered by priority: If the Cause of Death (LLT) (`name_meddra__v`) field is coded, the MedDRA code is exported. If a coded term is unavailable, the Cause of Death (Reported) (`name_reported__v`) field is exported.
B.1.10.1 Parent Identification	The value entered in the Patient ID field on the associated Parent-type Case.
B.1.10.2.1 Date of Birth of Parent	The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
B.1.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case. Note Ages above 100 are not exported.
B.1.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
B.1.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
B.1.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
B.1.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
B.1.10.6 Sex of Parent	The value entered in the Gender field on the associated Parent-type Case.
B.1.10.7.1a.1 MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
B.1.10.7.1a.2 Medical History (disease / surgical procedure/ etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1c Start Date (value)	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1d Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1f End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1g Comments	The text entered in the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters.
B.1.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The information entered in the Medical History Text field on the associated Parental-type Case, to a limit of 10,000 characters.
B.1.10.8a Name of Drug as Reported	The text entered in the Name Reported field on the Case Drug History object on the associated Parental-type Case.
B.1.10.8c Start date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
B.1.10.8e End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
B.1.10.8f.1 MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
B.1.10.8f.2 Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
B.1.10.8g.1 MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
B.1.10.8g.2 Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.

B.2 Reaction(s)/Event(s)

E2B Data Element Name

Populated Value

B.2.i.0 Reaction / Event as Reported by the Primary Source in Native Language

The text entered in the Event (Reported) field on the Case Adverse Event.

B.2.i.1a MedDRA Version for Reaction / Event (LLT)

Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.2.i.1b Reaction / Event (MedDRA code)

The value entered in the Event (MedDRA) field on the Case Adverse Event.

B.2.i.3 Term highlighted by the reporter

The value selected in the Highlighted Term field on the Case Adverse Event.

Seriousness criteria at event level

The appropriate seriousness is populated, based on the Seriousness field on the Case Adverse Event.

B.2.i.4b Date of start of reaction/event (value)

The date entered in the Onset field on the Case Adverse Event.

B.2.i.5b Date of end of reaction/event (value)

The date entered in the Resolved field on the Case Adverse Event.

B.2.i.6a Duration of reaction/event (value)

The value entered in the Duration field on the Case Adverse Event.

B.2.i.6b Duration of reaction/event (unit)

The unit entered in the Duration (unit) field on the Case Adverse Event.

B.2.i.7.1a Time interval between beginning of suspect drug administration and start of reaction/event

The value entered in the First Dose Latency (number) field on the Case Assessment.

B.2.i.7.1b Time interval unit between suspect drug administration and start of reaction/event

The unit selected in the First Dose Latency (unit) field on the Case Assessment.

B.2.i.7.2a Time interval between last dose and start of reaction/event

The value entered in the Last Dose Latency (number) field on the Case Assessment.

B.2.i.7.2b Time interval unit between last dose and start of reaction/event

The unit selected in the Last Dose Latency (unit) field on the Case Assessment.

B.2.i.8 Outcome of reaction/event at the time of last observation

The value selected in the Outcome field on the Case Adverse Event.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B(R2) Code values.

Vault E2B Code	E2B(R2) Code
1 - Recovered/Resolved	1 - Recovered/Resolved
2 - Recovering/Resolving	2 - Recovering/Resolving
3 - Not Recovered/Not Resolved/Ongoing	3 - Not Recovered/Not Resolved
4 - Recovered/Resolved with Sequelae	4 - Recovered/Resolved with Sequelae
5 - Fatal	5 - Fatal
0 - Unknown	6 - Unknown

B.3 Results of Tests and Procedures Relevant to the Investigation of the Patient

E2B Data Element Name	Populated Value
B.3.1 Test Date	The date entered in the Test Date field on the Case Test Result.
B.3.1c Test Name	For FDA and ICH E2B R2 exports, this field is exported from one of the following sources from the Case Test Result record, ordered by priority: If the Name MedDRA (LLT) (`name_meddra__v`) field is coded, the MedDRA code is exported. If a coded term is unavailable, the Test Name (Reported) (`name_reported__v`) field is exported.
B.3.1d Result	The value entered in the Test Result (Qualifier) and Test Result (Number) fields on the Case Test Result. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to B.3.2.
B.3.1e Test Result (unit)	The unit selected in the Result (Unit) field on the Case Test Result.
B.3.1.1 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
B.3.1.2 Normal High Value	The unit and value entered in the Normal High Value field on the Case Test Result. If the result does not have a unit, the system will map any text entered instead.
B.3.1.3 More Information Available	The value entered in the More Information Available field on the Case Test Result.
B.3.2 Results of tests and procedures relevant to the investigation of the patient	This data element is mapped from the following fields from a Case Test Result: Test Name (Code) If Test Name (Code) is blank, the Test Name (Reported) field is mapped instead. Test Date Result (Code) Result (Text) Comments Where these values are populated, they are exported to a limit of 2,000 characters. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element.

B.4 Drug(s) Information

E2B Data Element Name Populated Value

B.4.k.1 Characterisation of Drug Role

This value is mapped from the Drug Role option selected on the Case Product:

Drug Role	E2B Code
Suspect	`1`
Concomitant	`2`
Interacting	`3`
Treatment	N/A: Does not map to an E2B code
Drug Not Administered	`1`

B.4.k.2.1 Medicinal Product Name as Reported by the Primary Source The information entered in the Product (Reported) field on the Case Product.

B.4.k.2.2 Substance / Specified Substance Name The information entered in the Name (Reported) field on the Case Product Substance.

B.4.k.2.3 Identification of the Country Where the Drug Was Obtained The value entered in the Country Obtained field on the Case Product.

Investigational Product Blinded The value entered in the Blinded field on the Case Product.

B.4.k.4.1 Authorisation / Application Number

If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Number field on the Case Product.

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

B.4.k.4.2 Country of Authorisation / Application

If the Registration Country is within the jurisdiction of the agency, this is populated with the value entered in the Registration Country field on the Case Product.

If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.

B.4.k.4.3 Name of Holder / Applicant

If the Registration Country is within the jurisdiction of the agency or is blank, this is populated with the information entered in the Registration Holder/Applicant field on the Case Product.

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.

B.4.k.5.1 Dose (number)

The value entered in the Dose (number) field on the Case Product Dosage.

If the value exceeds character limits, additional text is mapped to B.4.k.6 Dosage Text.

B.4.k.5.2 Dose (unit)

The unit selected in the Dose (unit) field on the Case Product Dosage.

If the value exceeds character limits, additional text is mapped to B.4.k.6 Dosage Text.

B.4.k.5.3 Number of separate dosages Set to the number of individual Case Product Dosage records associated with the Case.

B.4.k.5.4 Number of Units in the Interval

The value entered in the Frequency field on the Case Product Dosage.

For FDA and ICH E2B R2 only, when a non-standard frequency measurement (cyclical, as necessary, or total) is specified in the Frequency field, this element is left blank and the non-standard unit is populated in data element B.4.k.6.

B.4.k.5.5 Definition of the Time Interval Unit

The appropriate E2B(R2) code is mapped based on the unit selected in the Frequency field on the Case Product Dosage.

B.4.k.12 Date and Time of Start of Drug The information entered in the First Administration field on the Case Product Dosage.

B.4.k.14 Date and Time of Last Administration The information entered in the Last Administration field on the Case Product Dosage.

B.4.k.15a Duration of Drug Administration (number) The value entered in the Duration (number) field on the Case Product Dosage.

B.4.k.15b Duration of Drug Administration (unit) The unit selected in the Duration (unit) field on the Case Product Dosage.

B.4.k.3 Batch / Lot Number The information entered in the Batch/Lot Number field on the Case Product Dosage.

B.4.k.6 Dosage Text

The information entered in the Dose Text field on the Case Product Dosage.

If the B.4.k.5.1 Dose (number) and B.4.k.5.2 Dose (unit) values exceed data element character limits, additional text is mapped to this data element, preceded by the label "DOSAGE:".

For FDA and ICH E2B R2 only, when a non-standard frequency measurement (cyclical, as necessary, or total) is specified in the Frequency field, the frequency value and unit are also mapped to this element.

B.4.k.7 Pharmaceutical Dose Form The information entered in the Dose Form Text field on the Case Product Dosage.

B.4.k.8 Route of Administration The Route of Administration E2B code or custom value in the Patient RoA field on the Case Product Dosage.

B.4.k.9 Parent Route of Administration The Route of Administration E2B code or custom value in the Parent RoA field on the Case Product Dosage.

B.4.k.5.6 Cumulative Dose to First Reaction (number)

The value entered in the Cumulative Dose field on the Case Product object.

If the value exceeds character limits, additional text is mapped to B.4.k.19 Additional Information on Drug (free text).

B.4.k.5.7 Cumulative Dose to First Reaction (unit)

The unit selected in the Cumulative Dose (unit) field on the Case Product object.

If the value exceeds character limits, additional text is mapped to B.4.k.19 Additional Information on Drug (free text).

B.4.k.10a Gestation Period at Time of Exposure (number) The value entered in the Gestation Exposure field on the Case Product object.

B.4.k.10b Gestation Period at Time of Exposure (unit) The unit selected in the Gestation Exposure (unit) field on the Case Product object.

B.4.k.11a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.4.k.16 Action(s) Taken with Drug

The value selected in the Action Taken field on the Case Product object.

You must select a Vault E2B Code value for this section.

See the following table for the E2B Code values and their corresponding E2B(R2) Code values.

Vault E2B Code	E2B(R2) Code
1 - Drug Withdrawn	1 - Drug Withdrawn
2 - Dose Reduced	2 - Dose Reduced
3 - Dose Increased	3 - Dose Increased
4 - Dose Not Changed	4 - Dose Not Changed
0 - Unknown	5 - Unknown
9 - Not Applicable	6 - Not Applicable

B.4.k.18.1a MedDRA version for reaction(s)/event(s) assessed Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.

B.4.k.18.1b Reaction(s) / Event(s) Assessed The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.

B.4.k.18.2 Source of Assessment

The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:

Source Type
Source (text)

B.4.k.18.3 Method of Assessment

The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:

Method of Assessment
Method (text)

B.4.k.18.4 Result of Assessment

The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:

Assessment Result (Override)
Note Your Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault.
Assessment Result
Result (text)

B.4.k.13.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) The value entered in the First Dose Latency (number) field on the Case Assessment.

B.4.k.13.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit) The unit selected in the First Dose Latency (unit) field on the Case Assessment.

B.4.k.13.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number) The value entered in the Last Dose Latency (number) field on the Case Assessment.

B.4.k.13.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit) The unit selected in the Last Dose Latency (unit) field on the Case Assessment.

B.4.k.17.1 Did Reaction Recur on Re-administration?

The appropriate value is populated, based on the option selected in the Reaction Recurrence field on the Case Assessment:

1: yes - yes (rechallenge was done, reaction reccurred)
2: yes - no (rechallenge was done, reaction did not recur)
3: no - n/a (no rechallenge was done, recurrance is not applicable) or yes - unk (rechallenge was done, outcome unknown)

B.4.k.19 Additional Information on Drug (free text)

This field is populated with data from the following sources:

The text entered in the Additional Information (text) field on the Case Product.
If the Blinded field is set to "Yes" on the Case Product, the system appends 'INVESTIGATIONAL' to this element.
If the Drug Role field is set to "Drug not administered" on the Case Product, the system appends 'DRUG NOT ADMINISTERED' to this element.
If the B.4.k.5.6 Cumulative Dose (number) and B.4.k.5.7 Cumulative Dose (unit) values exceed data element character limits, additional text is mapped to this data element, preceded by the label "CUMULATIVE DOSAGE:".

B.5 Narrative Case Summary and Further Information

E2B Data Element Name	Populated Value
B.5.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information	The text entered in the Narrative Text field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to “Narrative” or blank, the Localized Narrative document is populated to this element. For any other setup, only the primary narrative is exported. Any additional translated narratives and/or language tags are not exported.
B.5.2 Reporter's Comments	The text entered in the Reporter's Comments field on the Case, to a limit of 20,000 characters.
B.5.3a MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.5.3b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)	The MedDRA LLT coded on the Case Diagnosis.
B.5.4 Sender's Comments	The information entered in the Company Comments field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

FDA E2B(R2) Mapping

M.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name	Populated Value
M.1.1 Types of Message in Batch	For FDA and ICH E2B R2 exports, this element is always set to `1` for ICH ICSR.
M.1.2 Message Format Version	Set to default value `2.1` for an ICSR, or `1.0` for an acknowledgment.
M.1.3 Message Format Release	For FDA and ICH E2B R2 exports, this element is set to `1`.
M.1.4 Batch Number	The value entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
M.1.5 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
M.1.6 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
M.1.7b Date of Batch Transmission	Date and time when the report was generated or Transmitted, calculated with full precision down to the second.

ICH ICSR Message Header (message wrapper)

E2B Data Element Name	Populated Value
N.2.r.4 Date of Message Creation	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

A Administrative and Identification Numbers

A.1 Identification of the Case Safety Report

E2B Data Element Name	Populated Value
A.1.0.1 Sender's (case) Safety Report Unique Identifier	The value entered in the UID field on the Case Number object is populated in this element. Also, if the Safety Report Version field is populated on the Transmission (Submission or Distribution), then the <`safetyreportversion`> tag is populated with the text entered in the field.
A.1.1 Reporter's Country Code	The ISO code populated in the Country field on the Reporter-type Case Contact.
A.1.2 Identification of the Country Where the Reaction / Event Occurred	The value entered in the Event Country field on the primary Case Adverse Event.
A.1.3b Date of Transmission	If the Case is Approved or Closed, the date entered in the Approval Date field. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.
A.1.4 Type of Report	The appropriate value is populated, based on the option selected in the Report Type field on the Case `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
A.1.5.1 Serious	Set to `1` (Yes) if there is at least one Case Adverse Event with seriousness criteria.
A.1.5.2 Seriousness Criteria	Populated with seriousness tags corresponding to the criteria selected in the Seriousness field across all Case Adverse Events. A seriousness criteria tag is set to `1` (Yes) if there is at least one Case Adverse Event with that seriousness criteria.
A.1.6 Date Report Was First Received from Source	For initial Cases, the date entered in the Receipt Date field on the Case. For Follow-Up Cases, the date entered in the Initial Receipt Date field on the Case.
A.1.7 Date of Most Recent Information for This Report	The date entered in the New Info Date field on the Case.
A.1.8.1 Are Additional Documents Available	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment with the Retransmit field set to Yes.
A.1.8.2 Documents Held by Sender	The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment, to a limit of 2,000 characters.
A.1.9 Does this case fulfill the local criteria for an expedited report	For non-combination product reports, the system first attempts to use the Local Expedited Criteria (`case_expedited__v`) field on the Transmission (Submission or Distribution). If this field is not available on the Transmission, the system then looks at the Expedited field on the Case. With either field, the following logic applies: `1` (15-day): Populated when the expedited field value is Yes `2` (non-expedited): Populated when the expedited field value is No or both expedited fields are blank For combination product reports, the following logic applies: `4` (5-day): Populated when the Device Report Type field contains Public Health Risk. `5` (malfunction-only): Populated when the Device Report Type field is set to only Malfunction. If neither condition is met, the system uses the same logic as non-combination product reports to populate `1` or `2`.
A.1.10.1 Regulatory authority's case report number	The value entered in the Worldwide UID field on the Case Number object.
A.1.10.2 Other sender's case report number	The value entered in the First Sender field on the original inbound Transmission. The Transmission Date is used to find the original Transmission.
A.1.11 Other Case Identifiers in Previous Transmissions	Populated as True if there are any Case Identifier objects associated with the Case.
A.1.11.1 Source(s) of the Case Identifier	The value entered in the Source field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
A.1.11.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
A.1.12 Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
A.1.12 Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
A.1.13 Report Nullification / Amendment	Set to `1` when Nullification is selected in the Reason field on the Transmission.
A.1.13.1 Reason for Nullification / Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.
A.1.14 Medical Confirmation by Healthcare Professional	Populated based on the value in the HCP Confirmed field on the Case Adverse Event. This field is only transmitted when the Qualification field on the primary (Rank 1) Reporter-type Case Contact does not designate a health professional. That is, the Qualification Controlled Vocabulary does not correspond to E2B codes 1, 2, or 3.

A.2 Primary Source(s) of Information

E2B Data Element Name	Populated Value
A.2.1.1a Reporter's Title	The value entered in the Title field on a Reporter-type Case Contact.
A.2.1.1b Reporter's Given Name	The value entered in the First Name field on a Reporter-type Case Contact.
A.2.1.1c Reporter's Middle Name	The value entered in the Middle Name field on a Reporter-type Case Contact.
A.2.1.1d Reporter's Family Name	The value entered in the Last Name field on a Reporter-type Case Contact.
A.2.1.2a Reporter's Organisation	The value entered in the Organization field on a Reporter-type Case Contact.
A.2.1.2b Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
A.2.1.2c Reporter's Street	The value entered in the Street field on a Reporter-type Case Contact.
A.2.1.2d Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
A.2.1.2e Reporter's State or Province	The value entered in the State/Province field on a Reporter-type Case Contact.
A.2.1.2f Reporter's Postcode	The value entered in the Postal Code/Zip Code field on a Reporter-type Case Contact.
A.2.1.3 Reporter's Country Code	The ISO code populated in the Country field on a Reporter-type Case Contact.
A.2.1.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact.

A.3 Information on Sender and Reciever of Case Safety Report

E2B Data Element Name	Populated Value
A.3.1.1 Sender Type	The option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Sender Type from the Organization on the Case.
A.3.1.2 Sender's Organisation	The value entered in the Organisation field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default the system maps the Organization on the Case.
A.3.1.3a Sender's Department	The value entered in the Department field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3b Sender's Title	The value entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3c Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3d Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3e Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4a Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4b Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4c Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4d Sender's Postcode	The value entered in the Postal Code / Zip Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4e Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4f Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4i Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4 Sender's E-mail Address	The value entered in the Email field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.2.2 Literature Reference(s)	The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.
A.2.3.1 Study Name	For FDA and ICH E2B R2, the values entered in the Study Name and Study Name (Continued) fields on the associated Study, to a limit of 2,000 characters.
A.2.3.2 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
A.2.3.3 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type (`product_usage_reason__v`) field on the Case.
A.3.2.1 Receiver Type	The option selected in the Receiver Type field of the Receiver Person record on the Transmission Profile record. If a Receiver Person is not specified, the system maps the Sender Type from the Destination Organization on the Transmission Profile. Per E2B(R2) guidelines, only the following values are mapped: `1`: Pharmaceutical company `2`: Regulatory authority `4`: Regional pharmacovigilance center `5`: WHO collaborating center for international drug monitoring
A.3.2.2a Receiver's Organisation	The value entered in the Organization field of the Receiver Person record on the Transmission Profile record.
A.3.2.2b Receiver's Department	The value entered in the Department field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2c Receiver's Title	The value entered in the Title field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2d Receiver's Given Name	The value entered in the First Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2e Receiver's Middle Name	The value entered in the Middle Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2f Receiver's Family Name	The value entered in the Last Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3a Receiver's Street Address	The value entered in the Street field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3b Receiver's City	The value entered in the City field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3c Receiver's State or Province	The value entered in the State / Province field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3d Receiver's Postcode	The value entered in the Postal Code / Zip Code field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3e Receiver's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3f Receiver's Telephone	The value entered in the Telephone field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3g Receiver's Telephone Extension	The value entered in the Telephone Extension field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3h Receiver's Telephone Country	The value entered in the Telephone Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3i Receiver's Fax	The value entered in the Fax field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3j Receiver's Fax Extension	The value entered in the Fax Extension field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3k Receiver's Fax Country	The value entered in the Fax Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3l Receiver's E-mail Address	The value entered in the Email field in the Person record associated with the Receiver Person on the Transmission Profile record.

B Information on the Case

B.1 Patient Characteristics

E2B Data Element Name	Populated Value
B.1.1 Patient initials	The value entered in the Patient Initials / ID field on the Case.
B.1.1.1a GP medical record number	The value entered in the MRN - GP field on the Case.
B.1.1.1b Specialist record number	The value entered in the MRN - Specialist field on the Case.
B.1.1.1c Hospital record number	The value entered in the MRN - Hospital field on the Case.
B.1.1.1d Investigation number	The value entered in the MRN - Investigation field on the Case.
B.1.2.1 Date of birth	The date entered in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
B.1.2.2a Age at time of onset of reaction/event (number)	The value entered in the Age field on the Case. In accordance with ICH guidelines, this element is only transmitted when the Patient Date of Birth (B.1.2.1) is not transmitted.
B.1.2.2b Age at time of onset of reaction/event (unit)	The value selected in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is only transmitted when the Patient Date of Birth (B.1.2.1) is not transmitted.
B.1.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (value)	The value entered in the Gestation field on the Case.
B.1.2.2.1b Gestation Period When Reaction / Event Was Observed in the Foetus (unit)	The unit selected in the Gestation (unit) field on the Case.
B.1.2.3 Patient age group	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (B.1.2.1) and Age at Onset (B.1.2.2) are not transmitted.
B.1.3 Body Weight (kg)	The value entered in the Weight field on the Case.
B.1.4 Height (cm)	The value entered in the Height (normalized) field on the Case.
B.1.5 Sex	The option populated in the Gender field on the Case.
B.1.6 Last menstrual period date	The date entered in the Last Menstrual field on the Case.
B.1.7.1a.1 MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.7.1a.2 Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
B.1.7.1c Start Date	The date entered in the Start Date field on the Case Medical History object.
B.1.7.1d Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
B.1.7.1f End Date	The date entered in the End Date field on the Case Medical History object.
B.1.7.1g Comments	The text entered in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
Family history	The value selected in the Family History field on the Case Medical History object.
B.1.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered in the Medical History Text field on the Case, to a limit of 10,000 characters.
B.1.8a Name of Drug as Reported	The value entered in the Name Reported field on the Case Drug History Object.
B.1.8c Start date	The date entered in the Start Date field on the Case Drug History Object.
B.1.8e End Date	The value entered in the End Date field on the Case Drug History Object.
B.1.8f.1 MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.8f.2 Indication (MedDRA code)	The MedDRA LLT coded for the indication on the Case Drug History Object.
B.1.8g.1 MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.8g.2 Reaction (MedDRA code)	The value entered in the Reaction MedDRA field on the Case Drug History Object.
B.1.9.1 Date of Death	The date entered in the Date of Death field on the Case.
B.1.9.2a MedDRA Version for Reported Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.9.2b Reported Cause(s) of Death (MedDRA code)	This field is exported from one of the following sources from the Reported Case Cause of Death record, ordered by priority: If the Cause of Death (LLT) (`name_meddra__v`) field is coded, the MedDRA code is exported. If a coded term is unavailable, the Cause of Death (Reported) (`name_reported__v`) field is exported.
B.1.9.3 Was Autopsy Done?	The value selected in the Autopsy field on the Case.
B.1.9.4a MedDRA Version for Autopsy-determined Cause(s) of Death	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.9.4b Autopsy-determined Cause(s) of Death (MedDRA code)	This field is exported from one of the following sources from the Autopsy-Determined Case Cause of Death record, ordered by priority: If the Cause of Death (LLT) (`name_meddra__v`) field is coded, the MedDRA code is exported. If a coded term is unavailable, the Cause of Death (Reported) (`name_reported__v`) field is exported.
B.1.10.1 Parent Identification	The value entered in the Patient ID field on the associated Parent-type Case.
B.1.10.2.1 Date of Birth of Parent	The date entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
B.1.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case. Note Ages above 100 are not exported.
B.1.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
B.1.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
B.1.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
B.1.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
B.1.10.6 Sex of Parent	The value entered in the Gender field on the associated Parent-type Case.
B.1.10.7.1a.1 MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
B.1.10.7.1a.2 Medical History (disease / surgical procedure/ etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1c Start Date (value)	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1d Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1f End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
B.1.10.7.1g Comments	The text entered in the Comments field on the Case Medical History object on the associated Parental-type Case, to a limit of 2,000 characters.
B.1.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The information entered in the Medical History Text field on the associated Parental-type Case, to a limit of 10,000 characters.
B.1.10.8a Name of Drug as Reported	The text entered in the Name Reported field on the Case Drug History object on the associated Parental-type Case.
B.1.10.8c Start date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
B.1.10.8e End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
B.1.10.8f.1 MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
B.1.10.8f.2 Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
B.1.10.8g.1 MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
B.1.10.8g.2 Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.