E2B Generation: FDA E2B(R3) Mapping

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. This article describes how Vault maps information to generate FDA E2B(R3) files.

See E2B Generation Data Mapping for details about all other E2B formats supported by Vault Safety.

Note: Vault Safety automatically validates E2B files. Case and Submission Validation provides more information. In addition, Vault Safety enables you to configure custom Validation Criteria for Case data through the user-friendly Vault Expression Engine. For more information, see Configure Custom Validation Criteria.

FDA E2B(R3) Mapping

The following tables define how each E2B data element is mapped for a FDA E2B(R3) file. Use the section below to review 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	If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports `ZZFDA_PREMKT`. If the associated Transmission Profile is CDER or CBER, Vault exports `ZZFDA`. Otherwise, Vault exports the value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

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

E2B Data Element Name	Populated Value
N.2.r.1 Message Identifier	The value entered in the UID field on the Case.
N.2.r.2 Message Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	If the associated Transmission Profile is CDER, Vault exports "CDER". Otherwise, Vault exports 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

If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, this data element is populated with 2.

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, Vault uses this value. If this field is not specified on the Transmission, Vault 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).

If both fields are blank, nullFlavor (NI) is exported.

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.

Vault populates code 6 when the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt and any Case Adverse Events have a Seriousness that includes Death or Life Threatening.

Otherwise, Vault uses the following logic to populate this field:

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

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name	Populated Value
C.1.6.1 Are Additional Documents Available?	Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
C.1.6.1.r.1 Documents Held by Sender	The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment. Text is populated 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 and the Retransmit field set to Yes or blank, they are encoded. If the Retransmit field is set to No, documents are not 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. If there are no Case Identifier objects associated with the Case, `NI` is exported.
C.1.9.1.r.1 Source(s) of the Case Identifier	Repeated for the value entered in the Source field on each Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.9.1.r.2 Case Identifier(s)	The value entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
C.1.11.1 Report Nullification/Amendment	The appropriate value is populated, based on the option selected in the Reason field on the Transmission: `1`: Nullification `2`: Amendment
C.1.11.2 Reason for Nullification/Amendment	The text entered in the Reason Text field on the Transmission, to a limit of 2,000 characters.
FDA.C.1.12 Combination Product Report Indicator	Populated as "True" if the Case includes a Combination Product. If there are no Combination Products on the Case, `NI` is exported.

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. Any text that exceeds the 60-character limit for this data element is truncated.
C.2.r.2.2 Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street	The value entered in the Street Name field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province	Populates the State/Province field on the Case Contact object for the primary reporter. For Domestic Cases, Vault checks if the state or province is mapped to a domestic state code on a Country State/Province record. If a record exists, the Domestic State Code is exported to this field. This is useful for countries, such as Spain or Italy, where the state code is required in submissions to the EMA. If no mapping exists, the text value entered in the State/Province field is exported to this element.
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 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 Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization	The value entered in the Organization field in the User 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 Vault maps the Organization on the Case. Any text that exceeds the 100-character limit for this data element is truncated.
C.3.3.1 Sender's Department	The value entered in the Department field in the User 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 User 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 User 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 User 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 User 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 User 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 User 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 User 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 User 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 User 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 User 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 User 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 User record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

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

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value entered in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The values entered in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number	The value entered in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type field on the Case.
FDA.C.5.5a IND Number where AE Occurred	The value entered in the Study Registration Number field if the following are both true: The Transmission Profile associated with the Transmission (Submission or Distribution) record is CDER Study or CBER Study Any Case Adverse Events have a Seriousness of Death or Life Threatening
FDA.C.5.5b Pre-ANDA Number where AE Occurred	The value entered in the Study Registration Number field if the Transmission Profile associated with the Transmission (Submission or Distribution) record is CDER IND Exempt.
FDA.C.5.6.r IND number of cross reported IND	If the suspect Product is included in multiple Studies, Study Registration Numbers are exported for all Study Registrations with a Registration Type of Investigational New Drug (IND).

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 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 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 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 in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit 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 in the Weight field on the Case, normalized to the accepted unit.
D.4 Height (cm)	The value in the Height field on the Case, normalized to the accepted unit.
D.5 Sex	The option populated in the Gender field on the Case.
D.6 Last Menstrual Period Date	The date 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. 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.

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.
FDA.D.11.r.1 Patient Race Code	The appropriate NCI Concept Identifier is populated, based on the Race field on the Case.
FDA.D.12 Patient Ethnicity Code	The appropriate NCI Concept Identifier is populated, based on the Ethnicity field on the Case.

E.I Reaction/Event as Reported by the Primary Source

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 or Required Intervention to Prevent Permanent Impairment/Damage (Devices) is selected in the Seriousness field on the Case Adverse Event.

FDA.E.i.3.2h Required Intervention

For postmarket reports, this is set to "True" when the following are both true:

The Transmission Profile associated with the Transmission (Submission or Distribution) record is not CDER Study, CBER Study, or CDER IND Exempt
Any Case Adverse Events have a Seriousness of Required Intervention to Prevent Permanent Impairment/Damage (Devices)

Otherwise, this data element is set to NI.

E.i.4 Date of Start of Reaction / Event The date entered in the Onset field on the Case Adverse Event.

E.i.5 Date of End of Reaction / Event The date entered in the Resolved field on the Case Adverse Event.

E.i.6a Duration of Reaction / Event (number) The value entered in the Duration field on the Case Adverse Event.

E.i.6b Duration of Reaction / Event (unit) The unit entered in the Duration (unit) field on the Case Adverse Event.

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

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

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

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

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

E.i.8 Medical Confirmation by Healthcare Professional Populated based on the value in the HCP Confirmed field on the Case Adverse Event. This field is only transmitted when the Qualification field on the primary (Rank 1) Reporter-type Case Contact does not designate a health professional. That is, the Qualification Controlled Vocabulary does not correspond to E2B codes 1, 2, or 3.

E.i.9 Identification of the Country Where the Reaction / Event Occurred The value entered in the Event Country field on the Case Adverse Event.

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

E2B Data Element Name	Populated Value
F.r.1 Test Date	The date entered in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The information entered in the Test Name (Reported) field on the Case Test Result.
F.r.2.2a MedDRA Version for Test Name	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
F.r.2.2b Test Name (MedDRA code)	The MedDRA LLT coded on the Case Test Result.
F.r.3.1 Test Result (code)	The value selected in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.3 Test Result (unit)	The unit selected in the Result (Unit) field on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Case Test Result. In accordance with ICH guidelines, Vault adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element.
F.r.4 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, Vault 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, Vault 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 Characterisation 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.10a FDA Additional Information on Drug (coded) If the associated Transmission Profile is CDER IND Exempt, this is populated based on the Compounding Type value on the Product Registration record.

FDA.G.k.10.1 FDA Specialized Product Category Populated based on the Combination Type value on the Product Registration record.

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

G.k.2 Drug Identification

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

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

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

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

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

E2B Data Element Name

Populated Value

G.k.3.1 Authorisation / Application Number

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

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

G.k.3.2 Country of Authorisation / Application

If the Registration Country is within the jurisdiction of the agency, this is populated with the 2-letter country code for the country selected in the Registration Country field on the Case Product record.

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

G.k.3.3 Name of Holder / Applicant

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

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

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.1a Dose (number)	The value entered in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit selected in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value entered in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit selected in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The information entered in the First Administration field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The information entered in the Last Administration field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The value entered in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit selected in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours are selected.
G.k.4.r.8 Dosage Text	The information entered in the Dosage Text field on the Case Product Dosage. When a custom value is entered in the Dose (Unit) field, the Dose and Dose (Unit) values are mapped to this element, preceded by the label "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	If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports "Sponsor". For all other Transmission Profiles, Vault maps this value from one of the following fields on the Case Assessment Result, ordered by priority: Vault first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary. If Vault cannot map the E2B code, Vault maps the free text value from the Source (text) field.
G.k.9.i.2.r.2 Method of Assessment	If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports "FDA". For all other Transmission Profiles, Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority: Vault first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary. If Vault cannot map the E2B code, Vault maps the free text value from the Method (text) field.
G.k.9.i.2.r.3 Result of Assessment	Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority: If enabled, the value is mapped from the Assessment Result (Override) field. Note: An Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your Vault. Vault otherwise attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary. If Vault cannot map the E2B code, Vault maps the free text value from the Result (text) field.

E2B Data Element Name

Populated Value

G.k.9.i.2.r.1 Source of Assessment

If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports "Sponsor".

For all other Transmission Profiles, Vault maps this value from one of the following fields on the Case Assessment Result, ordered by priority:

Vault first attempts to map the E2B Code corresponding to the Source Type Controlled Vocabulary.
If Vault cannot map the E2B code, Vault maps the free text value from the Source (text) field.

G.k.9.i.2.r.2 Method of Assessment

If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports "FDA".

For all other Transmission Profiles, Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:

Vault first attempts to map the E2B Code corresponding to the Method of Assessment Controlled Vocabulary.
If Vault cannot map the E2B code, Vault maps the free text value from the Method (text) field.

G.k.9.i.2.r.3 Result of Assessment

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

If enabled, the value is mapped from the Assessment Result (Override) field.

Note: An Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your Vault.

Vault otherwise attempts to map the E2B Code corresponding to the Assessment Result Controlled Vocabulary.
If Vault cannot map the E2B code, Vault maps the free text value from the Result (text) field.

G.k.12 Device Information

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

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 on the Case, to a limit of 100,000 characters.
H.2 Reporter's Comments	The text from the Reporter's Comments field on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The information entered in the Company Comments field on the Case, to a limit of 20,000 characters. For Domestic Cases with Localization Scope set to Company Comments or blank, the Localized Company Comments are populated to this element.

H.3.r Sender's Diagnosis

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

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

E2B Data Element Name Populated Value

H.5.r.1a Case Summary and Reporter's Comments Text

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

If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters.

For Domestic Cases with Localization Scope set to "Narrative" or blank, the Localized Narrative document is populated to this element.

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

H.5.r.1b Case Summary and Reporter's Comments Language

The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative.

For Domestic Cases with Localization Scope set to "Narrative" or blank, the language selected on the Localized Narrative document (Document field (language_iso__v) is populated to this element.

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

FDA E2B(R3) Mapping - FDA Regional Mappings

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name Populated Value

N.1.4 Batch Receiver Identifier

E2B Data Element Name	Populated Value
N.1.4 Batch Receiver Identifier	If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports `ZZFDA_PREMKT`. If the associated Transmission Profile is CDER or CBER, Vault exports `ZZFDA`. Otherwise, Vault exports the value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.

If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, Vault exports ZZFDA_PREMKT.

If the associated Transmission Profile is CDER or CBER, Vault exports ZZFDA.

Otherwise, Vault exports the value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.

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

E2B Data Element Name	Populated Value
N.2.r.3 Message Receiver Identifier	If the associated Transmission Profile is CDER, Vault exports "CDER". Otherwise, Vault exports the value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.

E2B Data Element Name

Populated Value

N.2.r.3 Message Receiver Identifier

If the associated Transmission Profile is CDER, Vault exports "CDER".

Otherwise, Vault exports the value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value

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

If the associated Transmission Profile is CDER Study, CBER Study, or CDER IND Exempt, this data element is populated with 2.

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.

Otherwise, Vault 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.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
FDA.C.1.12 Combination Product Report Indicator	Populated as "True" if the Case includes a Combination Product. If there are no Combination Products on the Case, `NI` is exported.

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

E2B Data Element Name	Populated Value
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.5 Study Identification

E2B Data Element Name	Populated Value
FDA.C.5.5a IND Number where AE Occurred	The value entered in the Study Registration Number field if the following are both true: The Transmission Profile associated with the Transmission (Submission or Distribution) record is CDER Study or CBER Study Any Case Adverse Events have a Seriousness of Death or Life Threatening
FDA.C.5.5b Pre-ANDA Number where AE Occurred	The value entered in the Study Registration Number field if the Transmission Profile associated with the Transmission (Submission or Distribution) record is CDER IND Exempt.
FDA.C.5.6.r IND number of cross reported IND	If the suspect Product is included in multiple Studies, Study Registration Numbers are exported for all Study Registrations with a Registration Type of Investigational New Drug (IND).

E2B Data Element Name

Populated Value

FDA.C.5.5a IND Number where AE Occurred

The value entered in the Study Registration Number field if the following are both true:

The Transmission Profile associated with the Transmission (Submission or Distribution) record is CDER Study or CBER Study
Any Case Adverse Events have a Seriousness of Death or Life Threatening

FDA.C.5.5b Pre-ANDA Number where AE Occurred

The value entered in the Study Registration Number field if the Transmission Profile associated with the Transmission (Submission or Distribution) record is CDER IND Exempt.

FDA.C.5.6.r IND number of cross reported IND

If the suspect Product is included in multiple Studies, Study Registration Numbers are exported for all Study Registrations with a Registration Type of Investigational New Drug (IND).

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name	Populated Value
FDA.D.11.r.1 Patient Race Code	The appropriate NCI Concept Identifier is populated, based on the Race field on the Case.
FDA.D.12 Patient Ethnicity Code	The appropriate NCI Concept Identifier is populated, based on the Ethnicity field on the Case.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name Populated Value

FDA.E.i.3.2h Required Intervention

E2B Data Element Name	Populated Value
FDA.E.i.3.2h Required Intervention	For postmarket reports, this is set to "True" when the following are both true: The Transmission Profile associated with the Transmission (Submission or Distribution) record is not CDER Study, CBER Study, or CDER IND Exempt Any Case Adverse Events have a Seriousness of Required Intervention to Prevent Permanent Impairment/Damage (Devices) Otherwise, this data element is set to `NI`.

For postmarket reports, this is set to "True" when the following are both true:

The Transmission Profile associated with the Transmission (Submission or Distribution) record is not CDER Study, CBER Study, or CDER IND Exempt
Any Case Adverse Events have a Seriousness of Required Intervention to Prevent Permanent Impairment/Damage (Devices)

Otherwise, this data element is set to NI.

G.k Drug(s) Information

E2B Data Element Name	Populated Value
G.k.1.a FDA Other Characterisation of Drug Role	Set to `1` when the Drug Role field on the Case Product record is set to Similar Device.
FDA.G.k.10a FDA Additional Information on Drug (coded)	If the associated Transmission Profile is CDER IND Exempt, this is populated based on the Compounding Type value on the Product Registration record.
FDA.G.k.10.1 FDA Specialized Product Category	Populated based on the Combination Type value on the Product Registration record.

G.k.12 Device Information

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