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) 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 Profile associated with 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 with the Retransmit field set to Yes.
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 with the Retransmit field set to Yes, 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 with the Retransmit field set to Yes, 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.
C.1.9.1.r.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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.
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 The value entered in the State/Province 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.
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 value entered in the Study Name field 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 Date field on the Case Test Result.
F.r.2.1 Test Name (free text) The information entered in the 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 value entered in the Result (value) 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.3.3 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.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 The information entered in the Registration Number field on the Case Product record.
G.k.3.2 Country of Authorisation / Application The 2-letter country code for the country selected in the Registration Country field on the Case Product record.
G.k.3.3 Name of Holder / Applicant The information entered in the Registration Holder/Applicant field on the Case Product record.

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.
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:
  1. The system first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary.
  2. 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:
  1. The system first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary.
  2. 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:
  1. 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.
  2. The system otherwise attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary.
  3. 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 Sender Comments field on the Case, to a limit of 20,000 characters.

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.

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.

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 Profile associated with 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 with the Retransmit field set to Yes.
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 with the Retransmit field set to Yes, 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 with the Retransmit field set to Yes, 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.
C.1.9.1.r.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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.
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 the primary 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 The value entered in the State/Province 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.
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 value entered in the Study Name field 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 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 Date field on the Case Test Result.
F.r.2.1 Test Name (free text) The information entered in the 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 value entered in the Result (value) 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.3.3 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-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-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-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-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-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-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-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-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-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-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 The information entered in the Registration Number field on the Case Product record.
G.k.3.2 Country of Authorisation / Application The 2-letter country code for the country selected in the Registration Country field on the Case Product record.
G.k.3.3 Name of Holder / Applicant The information entered in the Registration Holder/Applicant field on the Case Product record.

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.
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:
  1. The system first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary.
  2. 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:
  1. The system first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary.
  2. 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:
  1. 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.
  2. The system otherwise attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary.
  3. 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 This element is populated with 1 (Yes) 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 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 The value selected on the Remedial Action field or the value entered in the Remedial Action - Other field on the Case object.

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 Sender Comments field on the Case, to a limit of 20,000 characters.

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.

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.

This information is separate from the data captured by H.2 Reporter's Comments.

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 Profile associated with 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 with the Retransmit field set to Yes.
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 with the Retransmit field set to Yes, 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 with the Retransmit field set to Yes, 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.
C.1.9.1.r.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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.
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 The value entered in the State/Province 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.
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 value entered in the Study Name field 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 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 Date field on the Case Test Result.
F.r.2.1 Test Name (free text) The information entered in the 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 value entered in the Result (value) 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.3.3 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.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 The information entered in the Registration Number field on the Case Product record.
G.k.3.2 Country of Authorisation / Application The 2-letter country code for the country selected in the Registration Country field on the Case Product record.
G.k.3.3 Name of Holder / Applicant The information entered in the Registration Holder/Applicant field on the Case Product record.

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.
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:
  1. The system first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary.
  2. 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:
  1. The system first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary.
  2. 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:
  1. 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.
  2. 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.
  3. 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 Sender Comments field on the Case, to a limit of 20,000 characters.

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.

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.

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 a Case Product Registration assigned PMDA Rank 1 (primary), 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 is 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 Profile associated with 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-case_number__v.name__v

For example: JP-VertBio-000001

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-case_number__v.name__v

For example: JP-VertBio-000001

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 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 with the Retransmit field set to Yes.
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 with the Retransmit field set to Yes. 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 with the Retransmit field set to Yes, 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.
localized_case_identifier__v.source__v
C.1.9.1.r.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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.
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 value entered in the Study Name field 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 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

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 Date field on the Case Test Result.
F.r.2.1 Test Name (free text) The information entered in the 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 value entered in the Result (value) 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.3.3 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.
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 Case Product Registrations under the Japan Localized Case that contain a value in the PMDA Rank field, ordered by rank. If there are no Case Product Registrations with a PMDA Rank, the system generates the entire PMDA E2B(R3) using ICH E2B(R3) mappings instead.

If some Case Products does not have a PMDA Rank assigned, the system transmits Localized Case Products that meet the following requirements:

  • The Case Product object type is not Device. All other object types are considered.
  • The Drug Role field must be set to "Suspect", "Interacting", or "Concomitant"
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.
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 If the Japan Localized Case contains a Localized Case Comment for the primary PMDA product transmitted in the G.k section where the Comments Label (comments_label__v) field is set to Company Comments (companys_comments__v), this is mapped from the Comments Text field.
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 selected on the Case Product Registration for the primary PMDA product transmitted in the G.k section.
case_product_registration__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 Transmission for the Japan Localized Case.
transmission__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 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), this is mapped from the Comments Text field.
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 Case Product Registration for the primary PMDA product transmitted in the G.k section, this element is transmitted with 1.
case_product_registration__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__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 Case Product Registration corresponding to the primary PMDA product transmitted in the G.k section.
case_product_registration__v.completeness__v.e2b_code__v
J2.7.2 Comments on Incompletion If the Japan Localized Case contains a Localized Case Comment for the primary PMDA product transmitted in the G.k section where the Comments Label (comments_label__v) field is set to Comments on Completeness (comments_on_completeness__v), this is mapped from the Comments Text field.
localized_case_comment__v.comments_text__v
J2.8.1 Downgrade Report If the Downgraded field is set to Yes on the Transmission for the Japan Localized Case, 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, 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), this is mapped from the Comments Text field.
localized_case_comment__v.comments_text__v
J2.9 Retrospective analysis of infections If the Japan Localized Case contains a Localized Case Comment for the primary PMDA product transmitted in the G.k section where the Comments Label (comments_label__v) field is set to Retrospective analysis of infections (retrospective_analysis_of_infections__v), this 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 for the primary PMDA product transmitted in the G.k section where the Comments Label (comments_label__v) field is set to Future Actions (future_actions__v), this 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 for the primary PMDA product transmitted in the G.k section where the Comments Label (comments_label__v) field is set to Other References (other_references__v), this is mapped from the Comments Text field.
localized_case_comment__v.comments_text__v
J2.12 Clinical Compound Number (CCN) The Clinical Compound Number field on the Case Product Registration for the primary PMDA product transmitted in section G.k. This element is only transmitted if the Registration Type on the Case Product Registration is set to one of the following values:
  • Unapproved
  • Under Partial Change Trial
  • Approved (excluding investigational drugs)
  • Unapproved (excluding investigational drugs)
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 The value from the Report Overview field on the Case Product Registration for the primary PMDA product transmitted in section G.k.
case_product_registration__v.report_overview__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 following logic to find the appropriate Person record to map to elements J2.18.2 to J2.18.4:

  1. The system finds an Email Destination (email_destination__v) record where:
    1. The parent Transmission Profile is for the PMDA.
    2. The Recipient Type is To (recipient_type__v == to__v)
  2. The system uses the contact information on the Person referenced in the Destination Person (destination_person__v) field to map 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 Person related to the PMDA Email Destination record.
person__sys.title__v
J2.18.3 Recipient's family name The Last Name field on the Person related to the PMDA Email Destination record.
person__sys.last_name__sys
J2.18.4 Recipient's given name The First Name field on the Person related to the PMDA Email Destination record.
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.
A.1.11.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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 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 value entered in the Study Name field 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 field on the Case.

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:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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 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:
  1. If the Name MedDRA (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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 Result (value) field on the Case Test Result.
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 The value selected in the Result (code) field on the Case Test Result. The information entered in the Result (Text) field on the Case Test Result. The information entered in the Comments field on the Case Test Result.

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 The information entered in the Registration Number field on the Case Product.
B.4.k.4.2 Country of Authorisation / Application The value entered in the Registration Country field on the Case Product.
B.4.k.4.3 Name of Holder / Applicant The information entered in the Registration Holder/Applicant field on the Case Product.
B.4.k.5.1 Dose (number) The value entered in the Dose (number) field on the Case Product Dosage.
B.4.k.5.2 Dose (unit) The unit selected in the Dose (unit) field on the Case Product Dosage.
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.

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.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.

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.
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.
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:
  1. Source Type
  2. 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:
  1. Method of Assessment
  2. 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:
  1. Assessment Result (Override)
    Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault.
  2. Assessment Result
  3. 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: no - n/a (no rechallenge was done, recurrance is not applicable) or yes - no (rechallenge was done, reaction did not recur)
  • 3: 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.

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.
Note 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 Sender Comments field on the Case, to a limit of 20,000 characters.

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. 1 (15-day): Populated when the expedited field value is Yes
    2. 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:
    1. 4 (5-day): Populated when the Device Report Type field contains Public Health Risk.
    2. 5 (malfunction-only): Populated when the Device Report Type field is set to only Malfunction.
    3. 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.
A.1.11.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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 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 value entered in the Study Name field 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 field on the Case.

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:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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 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:
  1. If the Name MedDRA (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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 Result (value) field on the Case Test Result.
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 The value selected in the Result (code) field on the Case Test Result. The information entered in the Result (Text) field on the Case Test Result. The information entered in the Comments field on the Case Test Result.

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 The information entered in the Registration Number field on the Case Product.
B.4.k.4.2 Country of Authorisation / Application The value entered in the Registration Country field on the Case Product.
B.4.k.4.3 Name of Holder / Applicant The information entered in the Registration Holder/Applicant field on the Case Product.
B.4.k.5.1 Dose (number) The value entered in the Dose (number) field on the Case Product Dosage.
B.4.k.5.2 Dose (unit) The unit selected in the Dose (unit) field on the Case Product Dosage.
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.

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.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.

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.
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.
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:
  1. Source Type
  2. 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:
  1. Method of Assessment
  2. 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:
  1. Assessment Result (Override)
    Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault.
  2. Assessment Result
  3. 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: no - n/a (no rechallenge was done, recurrance is not applicable) or yes - no (rechallenge was done, reaction did not recur)
  • 3: 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.

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.
Note 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 Sender Comments field on the Case, to a limit of 20,000 characters.

Combination Product Elements

E2B Data Element Name Populated Value
A.1.FDA.15 Combination Product Report Flag If the Combination Product field on the primary Case Product contains a value, this field is set to 1 (Yes).
A.2.1.3.FDA.4 Reporter's Email Address The value entered in the Email Address field on the Case Contact (Reporter).
B.4.k.2.4.FDA.1a Expiration Date Format The code for the appropriate format is specified, based on the date entered in the Expiration Date field on the Case Product.
B.4.k.2.4.FDA.1b Expiration Date The date entered in the Expiration Date field on the Case Product.
B.4.k.2.FDA.5 Product available for evaluation The value selected in the Device Available field on the device-type Case Product.
B.4.k.2.6.FDA.1a Product return date format The appropriate format is specified, based on the date entered in the Returned Date field on the device-type Case Product.
B.4.k.2.6.FDA.1b Product return date The date entered in the Returned Date field on the device-type Case Product.
B.4.k.20.FDA.1 Brand Name The value entered in the Product Name field on the Product record associated with the device-type Case Product.
B.4.k.20.FDA.2 Common Device Name The value entered in the Generic Name field on the Product record associated with the device-type Case Product.
B.4.k.20.FDA.3 Product Code The value entered in the Product Code field on the Product Registration record associated with the device-type Product Constituent.
B.4.k.20.FDA.4a Device Manufacturer Name
  • If there is an organization linked to in the Manufacturer field on the corresponding Product record, the name of that organization.
  • Otherwise, this value is mapped from the name of the organization linked to in the Organization field on the Product record.
B.4.k.20.FDA.4b Manufacturer Address
  • If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the Street field on that Organization record.
  • Otherwise, this value is mapped from the Street field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.4c Manufacturer City
  • If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the City field on that Organization record.
  • Otherwise, this value is mapped from the City field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.4d Manufacturer State
  • If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the State field on that Organization record.
  • Otherwise, this value is mapped from the State field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.4e Manufacturer Country
  • If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the Country field on that Organization record.
  • Otherwise, this value is mapped from the Country field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.5 Model Number The value entered in the Model Number field on the device-type Case Product.
B.4.k.20.FDA.6 Catalog Number The value entered in the Catalog Number field on the device-type Case Product.
B.4.k.20.FDA.7 Serial Number The value entered in the Serial Number field on the device-type Case Product.
B.4.k.20.FDA.8 Unique Identifier UDI# The value entered in the Unique Identifier field on the device-type Case Product.
B.4.k.20.FDA.9a Implant Date Format The appropriate format is specified, based on the date entered in the Date Implanted field on the device-type Case Product.
B.4.k.20.FDA.9b Implanted Date The value entered in the Date Implanted field on the device-type Case Product.
B.4.k.20.FDA.10a Explanted Date Format The appropriate format is specified, based on the date entered in the Date Explanted field on the device-type Case Product.
B.4.k.20.FDA.10b Explanted Date The value entered in the Date Explanted field on the device-type Case Product.
B.4.k.20.FDA.11a Approximate age of device/product The value entered in the Device Age - Number field on the device-type Case Product.
B.4.k.20.FDA.11b Approximate age unit of device/product The unit selected in the Device Age - Unit field on the device-type Case Product.
B.4.k.20.FDA.12 Single Use Device The value entered in the Single Use field on the device-type Case Product.
B.4.k.20.FDA.13a Device Manufacture Date Format The appropriate format is specified, based on the date entered in the Manufacture Date field on the device-type Case Product.
B.4.k.20.FDA.13b Device Manufacture Date The value entered in the Manufacture Date field on the device-type Case Product.
B.4.k.20.FDA.14.1a Recall This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Recall.
B.4.k.20.FDA.14.1b Repair This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Repair.
B.4.k.20.FDA.14.1c Replace This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Replace.
B.4.k.20.FDA.14.1d Relabeling This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Relabeling.
B.4.k.20.FDA.14.1e Notification This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Notification.
B.4.k.20.FDA.14.1f Inspection This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Inspection.
B.4.k.20.FDA.14.1g Patient monitoring This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Patient Monitoring.
B.4.k.20.FDA.14.1h Modification/Adjustment This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Modification/Adjustment.
B.4.k.20.FDA.14.1i Other This element is populated with 1 (Yes) when the Remedial Action field on the Case is set to Other.
B.4.k.20.FDA.15 Device Usage The value entered in the Device Usage Type field on the device-type Case Product.
B.4.k.20.FDA.16 Device Lot Number The value selected in the Lot Number field on the Product record associated with the device-type Case Product.
B.4.k.20.FDA.17 Malfunction This element is populated with 1 (Yes) when the Device Report Type field on the Case contains Malfunction.
B.4.k.20.FDA.18.1a Correction This element is populated with 1 (Yes) when the Device Follow-Up Type field on the Case is set to Correction.
B.4.k.20.FDA.18.1b Additional Information This element is populated with 1 (Yes) when the Device Follow-Up Type field on the Case is set to Additional Information.
B.4.k.20.FDA.18.1c Response to FDA request This element is populated with 1 (Yes) when the Device Follow-Up Type field on the Case is set to Response to FDA Request.
B.4.k.20.FDA.18.1d Device Evaluation This element is populated with 1 (Yes) when the Device Evaluation field on the Case is set to Response to FDA Request.
B.4.k.20.FDA.19.1a Evaluation Type The value selected in the Evaluation Type field on the Product record associated with the device-type Case Product.
B.4.k.20.FDA.19.1b Evaluation Value The value is mapped from the Device Code object, using various fields on the device-type Case Product, namely:
  • Device Problem
  • Evaluation Conclusion
  • Evaluation Method
  • Evaluation Result
B.4.k.20.FDA.20 Operator of the Device The value selected in the Operator of Device field on the Product record associated with the device-type Case Product.

Health Canada 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 Health Canada E2B R2 exports, the system maps this element from the Message Type (HC) field on the Transmission.

If the Message Type (HC) field is blank, a default value is assigned using the following logic:

  • 1 (ichicsr): For all non-clinical trial cases.
  • 2 (cticsr): For clinical trial cases, defined by the following conditions:
    • The Case Report Type field is set to a Study report type. That is, the E2B Code on the Report Type Controlled Vocabulary is set to 2.
    • The Case Study Type field meets either of the following conditions:
      1. Set to a Clinical Trial study type. That is, the E2B Code on the Study Type Controlled Vocabulary is set to 1.
      2. The Study Type field on the Case is left blank.
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 Health Canada E2B R2 exports, this element is set to 2.
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.
A.1.11.2 Case Identifier(s) The value entered in the Name field on the Case Identifier object.
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 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.3.2.1 Receiver type For Health Canada E2B R2 exports, this element is mapped from the option selected in the Sender Type field in the Organization selected in the Destination field on the associated Submission record.
A.3.2.2b-f Receiver identifier For Health Canada E2B R2 exports, this element is mapped from the value entered in the Destination ID field on the Transmission Profile associated with the Submission 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 When the Study Type (A.2.3.3) is Clinical Trial or blank, the system populates this element using the following format:

(CTA Number)#(Study Name)

  • CTA Number: If there is an associated Study Registration with a Registration Type of CTA and the Country is set to Canada, the value in the Registration Number field is populated as the CTA number. In all other cases, this element is populated with Unknown.
  • Study Name: The value entered in the Study Name field on the associated Study, to a limit of 2,000 characters. If the Study Name is blank, this element is populated with Unknown.

When the Study Type (A.2.3.3) is any other value, this element is populated with the value entered in the Study Name field on the associated Study, to a limit of 2,000 characters. If the Study Name is blank, this element is populated with Unknown.

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 field on the Case.

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:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. 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 Date field on the Case Test Result.
B.3.1c Test Name For Health Canada E2B R2, if the Case Test Result record contains a coded value in the Name MedDRA (LLT) (name_meddra__v) field, the MedDRA code is exported.
If a coded term is not available but a reported term is, the Test Name (Reported) (name_reported__v) field is exported to B.3.2.
B.3.1d Result The value entered in the Result (value) field on the Case Test Result.
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 The value selected in the Result (code) field on the Case Test Result. The information entered in the Result (Text) field on the Case Test Result. The information entered in the Comments field on the Case Test Result.
If a coded term is not available for B.3.1c but a reported term is, the Test Name (Reported) (name_reported__v) field is also exported to B.3.2.

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 The information entered in the Registration Number field on the Case Product.
B.4.k.4.2 Country of Authorisation / Application The value entered in the Registration Country field on the Case Product.
B.4.k.4.3 Name of Holder / Applicant The information entered in the Registration Holder/Applicant field on the Case Product.
B.4.k.5.1 Dose (number) The value entered in the Dose (number) field on the Case Product Dosage.
B.4.k.5.2 Dose (unit) The unit selected in the Dose (unit) field on the Case Product Dosage.
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.
B.4.k.5.5 Definition of the Time Interval Unit The appropriate Health Canada 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.
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. For Health Canada E2B R2, the default value is 065 for Unknown when the Patient RoA field is blank.
B.4.k.9 Parent Route of Administration The information entered in the Parent RoA TermID 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.
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.
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.11b Indication (MedDRA code) For Health Canada E2B R2, this element is populated with the MedDRA LLT coded on the Case Product Indication.
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:
  1. Source Type
  2. 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:
  1. Method of Assessment
  2. 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:
  1. Assessment Result (Override)
    Note An administrator must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your vault.
  2. Assessment Result
  3. 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: no - n/a (no rechallenge was done, recurrance is not applicable) or yes - no (rechallenge was done, reaction did not recur)
  • 3: 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.

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.
Note 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 Sender Comments field on the Case, to a limit of 20,000 characters.

CIOMS I Generation Data Mapping
Case and Submission Validation
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