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 in the E2B Message ID field on the ICSR Transmission.
N.1.3 Batch Sender Identifier	The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission.
N.1.4 Batch Receiver Identifier	If the FDA Batch Receiver Identifier field on the associated Transmission Profile contains a value, Vault exports this value. 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 ICSR Transmission.
N.1.5 Date of Batch Transmission	The value in the Transmission Date field on the ICSR Transmission. 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 in the UID field on the Case.
N.2.r.2 Message Sender Identifier	The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission.
N.2.r.3 Message Receiver Identifier	If the FDA Message Receiver Identifier field on the associated Transmission Profile contains a value, Vault exports this value. 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 ICSR Transmission.
N.2.r.4 Date of Message Creation	If the Case is Approved, Closed, or Superseded, the date in the Approval Date field.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 UID on the Case Version.

C.1.2 Date of Creation If the Case is Approved, Closed, or Superseded, the date in the Approval Date field. 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

Vault populates a code based on the Report Type of the Case:

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

C.1.4 Date Report Was First Received from Source For initial and follow-up Cases, the Receipt Date on the Case. When the Receipt Date includes a time and time zone, Vault truncates the value to YYYYMMDD.

C.1.5 Date of Most Recent Information for This Report The New Info Date on the Case. When the New Info Date includes a time and time zone, Vault truncates the value to YYYYMMDD.

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 ICSR Transmission 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, Vault populates this element with 1 (expedited). Otherwise, Vault populates this element 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-type Case Products, this field auto-generates upon E2B file creation.

Vault populates code 6 when the following Case criteria are met:

Any Case Adverse Event has a Seriousness that includes Death or Life Threatening
The associated Transmission Profile is CDER Study or CBER Study
The Study Type is Clinical Trial
The Report Type is Study or Literature (Study)

Otherwise, Vault uses the following logic to populate this data element:

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 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, they are encoded. If the Retransmit field is set to No or is blank, documents are not encoded. Depending on your Admin's configuration, Vault may exclude attachment contents on Transmissions for Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.

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 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, they are encoded. If the Retransmit field is set to No or is blank, documents are not encoded.

Depending on your Admin's configuration, Vault may exclude attachment contents on Transmissions for Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The Worldwide UID on the Case Version.
C.1.8.2 First Sender of This Case	The value 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 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 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 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 in the Reason Text field on the Transmission, to a limit of 2,000 characters.
FDA.C.1.12 Combination Product Report Indicator	If the Case includes a Combination Product, set to `true`. If there are no Combination Products on the Case, set to `false`.

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

E2B Data Element Name	Populated Value
C.2.r.1.1 Reporter's Title	The value in the Title field on a Reporter-type Case Contact.
C.2.r.1.2 Reporter's Given Name	The value in the First Name field on a Reporter-type Case Contact.
C.2.r.1.3 Reporter's Middle Name	The value in the Middle Name field on a Reporter-type Case Contact.
C.2.r.1.4 Reporter's Family Name	The value in the Last Name field on a Reporter-type Case Contact.
C.2.r.2.1 Reporter's Organisation	The value 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 in the Department field on a Reporter-type Case Contact.
C.2.r.2.3 Reporter's Street	The value in the Street Name field on a Reporter-type Case Contact.
C.2.r.2.4 Reporter's City	The value in the City field on a Reporter-type Case Contact.
C.2.r.2.5 Reporter's State or Province	The State/Province on the Case Contact record for the primary reporter.
C.2.r.2.6 Reporter's Postcode	The value in the Zip/Postal Code field on a Reporter-type Case Contact.
C.2.r.2.7 Reporter's Telephone	The value in the Telephone field on a Reporter-type Case Contact.
FDA.C.2.r.2.8 Reporter's Email	The value in the Reporter's Email Address field on a Reporter-type Case Contact.
C.2.r.3 Reporter's Country Code	The ISO code in the Country field on a Reporter-type Case Contact.
C.2.r.4 Qualification	The value 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 value in the Sender Type field in the Organization record associated with the Sender (User) on the ICSR Transmission. If the Sender (User) is not specified on the Transmission, Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization	The value in the Organization field in the User record associated with the Sender (User) on the ICSR Transmission. If the Sender (User) is not specified on the Transmission, 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 in the Department field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.2 Sender's Title	The value in the Title field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.3 Sender's Given Name	The value in the First Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.4 Sender's Middle Name	The value in the Middle Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.5 Sender's Family Name	The value in the Last Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.1 Sender's Street Address	The value in the Street field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.2 Sender's City	The value in the City field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.3 Sender's State or Province	The value in the State / Province field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.4 Sender's Postcode	The value in the Zip/Postal Code field in the User record associated with the Sender (User) on the ICSR Transmission.
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 ICSR Transmission.
C.3.4.6 Sender's Telephone	The value in the Telephone field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.7 Sender's Fax	The value in the Fax field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.8 Sender's E-mail Address	The value in the Email field in the User record associated with the Sender (User) on the ICSR Transmission.

C.4.r Literature Reference(s)

E2B Data Element Name	Populated Value
C.4.r.1 Literature Reference(s)	The value in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters. When Vault generates a report for a Case linked to a Literature Article in your SafetyDocs Vault and if the document's Retransmit field value is Yes, Vault maps a value from the Literature Article using the following priority: Vancouver Citation (English) Vancouver Citation For Localized Case Documents, Vault overrides the Vancouver Citation with the Reference field value, if populated. Multiple literature source documents are encoded in separate C.4.r.1 blocks.
C.4.r.2 Included Documents	Case documents of the following classifications with the Retransmit field value of Yes are encoded in Transmissions: Case > Source > Literature Literature > Literature Article > Full-Text Literature > Literature Article > Summary Depending on your Admin's configuration, Vault may exclude the contents of literature articles on Transmissions for Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

E2B Data Element Name

Populated Value

C.4.r.1 Literature Reference(s)

The value in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.

When Vault generates a report for a Case linked to a Literature Article in your SafetyDocs Vault and if the document's Retransmit field value is Yes, Vault maps a value from the Literature Article using the following priority:

Vancouver Citation (English)
Vancouver Citation

For Localized Case Documents, Vault overrides the Vancouver Citation with the Reference field value, if populated.

Multiple literature source documents are encoded in separate C.4.r.1 blocks.

C.4.r.2 Included Documents

Case documents of the following classifications with the Retransmit field value of Yes are encoded in Transmissions:

Case > Source > Literature
Literature > Literature Article > Full-Text
Literature > Literature Article > Summary

Depending on your Admin's configuration, Vault may exclude the contents of literature articles on Transmissions for Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The Registration Number on the Case Study Registration.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the Country on the Case Study Registration.
C.5.2 Study Name	The values 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 Study Number on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	Based on the Study Type on the Case, Vault populates an E2B code corresponding to the Study Type controlled vocabulary.
FDA.C.5.5a IND Number where AE Occurred	For study Cases with a Study Type of Clinical Trial or Individual Patient Use, Vault exports the Study Registration Number based on if the Study is registered with the United States: If the Study has one Study Registration for the United States, Vault exports the Study Registration Number on the Study Registration. If the Study has multiple Study Registrations for the United States, Vault exports the Study Registration Number from the record with the earliest creation date. When cross-reporting for a Study without any Study Registrations for the United States, Vault exports a Study Registration Number from the cross-reported studies associated with a Transmission Study on the Transmission. Vault exports the Study Registration Number from the earliest created Study Registration with Yes in the FDA Primary IND field. If no Study Registrations have Yes in the FDA Primary IND field, Vault exports the Study Registration Number from the cross-reported studies associated with a Transmission Study on the Transmission that includes a Study Registration Number with the earliest created date. For any of the above scenarios, if no Study Registrations include a Study Registration Number, Vault exports this data element as blank.
FDA.C.5.5b Pre-ANDA Number where AE Occurred	The value in the Study Registration Number field if the Transmission Profile associated with the ICSR Transmission is CDER IND Exempt.
FDA.C.5.6.r IND number of cross reported IND	If the suspect product is included in multiple studies, Vault exports Study Registration Numbers for all reportable Study Registrations with a Registration Type of Investigational New Drug (IND) when the Transmission Profile associated with the Transmission is not CDER, CBER, or CDER IND Exempt. Vault creates Transmission Study records for all reportable Study Registrations.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value 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 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 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 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 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 of Birth on the Case. For Vault to transmit this value, the full date is required with year, month, and day.
D.2.2a Age at Time of Onset of Reaction / Event (number)	The Age on the Case.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The Age (unit) on the Case.
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 value in the Age Group field on the Case. In accordance with ICH guidelines, this element is transmitted only 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 value in the Sex 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 record.
D.7.1.r.2 Start Date	The date in the Start Date field on the Case Medical History record.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History record.
D.7.1.r.4 End Date	The date in the End Date field on the Case Medical History record.
D.7.1.r.5 Comments	The text in the Comments field on the Case Medical History record, to a limit of 2,000 characters.
D.7.1.r.6 Family History	The value in the Family History field on the Case Medical History record.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text 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 in the Drug (Reported) field on the Case Drug History record.
D.8.r.2a MPID Version Date/Number	The MPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format.
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 PhPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date in the Start Date field on the Case Drug History record.
D.8.r.5 End Date	The date 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 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 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 in the Name (Reported) field on the Case Cause of Death record.
D.9.3 Was Autopsy Done?	The value 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 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 Patient ID on the associated Parent Information.
D.10.2.1 Date of Birth of Parent	The Date of Birth on the associated Parent Information. For Vault to transmit this value, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The Age on the associated Parent Information.
D.10.2.2b Age of Parent (unit)	The Age (unit) on the associated Parent Information.
D.10.3 Last Menstrual Period Date of Parent	The date in the Last Menstrual field on the associated Parent Information.
D.10.4 Body Weight (kg) of Parent	The value in the Weight field on the associated Parent Information.
D.10.5 Height (cm) of Parent	The value in the Height (normalized) field on the associated Parent Information.
D.10.6 Sex of Parent	The value in the Sex field on the associated Parent Information.
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 Parent Information.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.2 Start Date	The date in the Start Date field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.3 Continuing	The value in the Continuing field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.4 End Date	The date in the End Date field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.5 Comments	The text in the Comments field on the Case Medical History record on the associated Parent Information, to a limit of 2,000 characters.
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent	The text in the Medical History Text field on the associated Parent Information, 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 in the Name Reported field on the Case Drug History record on the associated Parent Information.
D.10.8.r.2a MPID Version Date/Number	The MPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value in the MPID field on the Case Drug History record on the associated Parent Information.
D.10.8.r.3a PhPID Version Date/Number	The PhPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value in the PhPID field on the Case Drug History record on the associated Parent Information.
D.10.8.r.4 Start Date	The date in the Start Date field on the Case Drug History record on the associated Parent Information.
D.10.8.r.5 End Date	The date in the End Date field on the Case Drug History record on the associated Parent Information.
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 Parent Information.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History record on the associated Parent Information.
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 Parent Information.
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 Parent Information.
FDA.D.11.r.1 Patient Race Code	Based on the Race on the Case, Vault populates an NCI Concept Identifier. If the FDA Summary Type in the Details section of the Case is Aggregate or Summary, Vault populates the nullFlavor `NA` in this data element.
FDA.D.12 Patient Ethnicity Code	Based on the Ethnicity on the Case, Vault populates an NCI Concept Identifier. If the FDA Summary Type in the Details section of the Case is Aggregate or Summary, Vault populates the nullFlavor `NA` in this data element.

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	Depending on your Vault's Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) field from either the global Case Adverse Event or the Localized Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language	Depending on your Vault's Deferred Domestic Processing: Localized Event Reported in Native Language setting, Vault exports the Event (Reported) - Language field from either the global Case Adverse Event or the Localized Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation	The text 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 Event (LLT) on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value 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 ICSR Transmission 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 in the Onset field on the Case Adverse Event.

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

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

E.i.6b Duration of Reaction / Event (unit) The unit 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 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 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 or the Reason Omitted value in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The value 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 in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values 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 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 value 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 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 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 value in the Comments field on the Case Test Result.
F.r.7 More Information Available	The value 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

Vault populates 4 to indicate Drug Not Administered in the following instances:

For premarket Cases, meaning the Transmission Profile associated with the Transmission is not CDER, CBER, or CDER IND Exempt, the Drug Role of the Case Product is Drug Not Administered
For Cases with Combination Products, the Device Report Type includes Malfunction and the Drug Role of the Case Product is Similar Device

In all other instances, Vault populates the E2B code from the Drug Role controlled vocabulary corresponding to the value in the Drug Role of the Case Product.

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 in the Country Obtained field on the Case Product record.

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

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

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

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

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

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

The value 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 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 not CDER IND Exempt, Vault exports an E2B code based on the Compounding Type of the Case Product as follows:

For Bulk Ingredient, Vault exports 3.
For Bulk Ingredient For Human Prescription Compounding, Vault exports 4.
For Unapproved Drug Product Manufactured Exclusively for Private Label Distributer, Vault exports 5.
For any other value or blank, Vault exports nullFlavor NA.

If the associated Transmission Profile is CDER IND Exempt, Vault exports an E2B code based on the FDA Additional Information On Drug value of the Case Product as follows:

For Test, Vault exports 1.
For Reference, Vault exports 2.
For any other value or blank, Vault exports nullFlavor NA.

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 value 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 MPID Version on the Case Product. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format.
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 PhPID Version on the Case Product. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source	The value 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 Name (Reported) on the Case Product Substance.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The TermID Version on the Case Product Substance. When the value corresponds to a date, Vault converts it to `YYYYMMDD` format. Vault exports this value only if there is no MPID Version on the Case Product.
G.k.2.3.r.2b Substance / Specified Substance TermID	The TermID on the Case Product Substance. Vault exports this value only if there is no MPID on the Case Product.
G.k.2.3.r.3a Strength (number)	The Strength (Number) on the Case Product Substance.
G.k.2.3.r.3b Strength (unit)	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 in the Dose (number) field on the Case Product Dosage.
G.k.4.r.1b Dose (unit)	The unit in the Dose (unit) field on the Case Product Dosage.
G.k.4.r.2 Number of Units in the Interval	The value in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The value in the First Admin Date field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The value in the Last Admin Date field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The Duration (number) on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The value in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavors are selected.
G.k.4.r.8 Dosage Text	The Dosage Text on the Case Product Dosage. When the Dose (Unit) is a custom value, Vault maps the Dose and Dose (Unit) values to this element preceded by the label `DOSAGE:`.
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	For postmarket Cases, if the Dose Form Text on the Case Product Dosage maps to a current EDQM term, Vault exports the EDQM Name on the EDQM record. For clinical trial study Cases, or if the value does not map to a current EDQM term, Vault exports the Name on the Case Product Dosage.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	For postmarket Cases, if the Dose Form TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	For postmarket Cases, if the Dose Form TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.10.1 Route of Administration	For postmarket Cases, if the Patient RoA on the Case Product Dosage maps to a current EDQM term, Vault exports the EDQM Name on the EDQM record. For clinical trial study Cases, or if the value does not map to a current EDQM term, Vault exports the Name on the Case Product Dosage.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	For postmarket Cases, if the Patient RoA TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.10.2b Route of Administration TermID	For postmarket Cases, if the Patient RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.11.1 Parent Route of Administration (free text)	For postmarket Cases, if the Parent RoA on the Case Product Dosage maps to a current EDQM term, Vault exports the EDQM Name. For clinical trial study Cases, or if the value does not map to a current EDQM term, Vault exports the Name on the Case Product Dosage.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	For postmarket Cases, if the Parent RoA TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.11.2b Parent Route of Administration TermID	For postmarket Cases, if the Parent RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.

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

Vault does not export this section for device constituent assessments.

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 First Dose Latency (number) 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 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 Last Dose Latency (number) 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 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 value in the Reaction Recurrence field on the Case Assessment: `1`: yes - yes (rechallenge was done, reaction recurred) `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, recurrence is not applicable)

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

Vault does not export this section for device constituent assessments.

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1 Source of Assessment	If the associated Transmission Profile is not CDER, CBER, or CDER IND Exempt, Vault maps values from Case Assessment Results with Sponsor as the Source Type. If there are no Case Assessment Results with Sponsor as the Source Type or if the Transmission Profile is CDER, CBER, or CDER IND Exempt, Vault maps values from all Case Assessment Results, regardless of the Source Type. For both scenarios, Vault maps values using the following priority: The E2B code corresponding to the Source Type controlled vocabulary The Source (text)
G.k.9.i.2.r.2 Method of Assessment	If the associated Transmission Profile is not CDER, CBER, or CDER IND Exempt, for Case Assessment Results with Sponsor as the Source Type, Vault populates `FDA`. If there are no Case Assessment Results with Sponsor as the Source Type or if the Transmission Profile is CDER, CBER, or CDER IND Exempt, Vault maps values from all Case Assessment Results, regardless of the Source Type, using the following priority: The value corresponding to the Method of Assessment controlled vocabulary The Method (text)
G.k.9.i.2.r.3 Result of Assessment	If the associated Transmission Profile is not CDER, CBER, or CDER IND Exempt, Vault maps values from Case Assessment Results with Sponsor as the Source Type. If there are no Case Assessment Results with Sponsor as the Source Type or if the Transmission Profile is CDER, CBER, or CDER IND Exempt, Vault maps values from all Case Assessment Results, regardless of the Source Type. For both scenarios, Vault maps values using the following priority: If enabled, Assessment Result (Override) Note: Your Admin must add the Assessment Result (Override) field to the Case Assessment Result layout and Veeva Support must enable this usage in your Vault. The Assessment Result picklist value corresponding to the Case Assessment Result controlled vocabulary For clinical trial study Cases, Vault exports Case Assessment Results set to Related as `Suspected` and set to Not Related as `Not Suspected`. The Result (text)

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	Vault populates a value using the following priority order: The Product Code on the Case Product The Product Code on the Product Registration of the constituent of the Case Product The Product Code on the Product Registration of the associated Combination 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 Reporter's Comments on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments	The value 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 as Case > Summary > Narrative, Vault populates the contents of that document in this element, to a limit of 100,000 characters. For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the localized narrative document 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 as Case > Summary > Narrative. For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the language selected on the localized narrative document field (`language_iso__v`) to this element. This information is separate from the data captured by H.2 Reporter's Comments.

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

For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the localized narrative document 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 as Case > Summary > Narrative.

For Localized Cases with Localization Scope set to Narrative or blank, Vault populates the language selected on the localized narrative document field (language_iso__v) to this element.

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

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 FDA Batch Receiver Identifier field on the associated Transmission Profile contains a value, Vault exports this value. 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 ICSR Transmission.

If the FDA Batch Receiver Identifier field on the associated Transmission Profile contains a value, Vault exports this value.

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 ICSR Transmission.

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

E2B Data Element Name Populated Value

N.2.r.3 Message Receiver Identifier

E2B Data Element Name	Populated Value
N.2.r.3 Message Receiver Identifier	If the FDA Message Receiver Identifier field on the associated Transmission Profile contains a value, Vault exports this value. 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 ICSR Transmission.

If the FDA Message Receiver Identifier field on the associated Transmission Profile contains a value, Vault exports this value.

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 ICSR Transmission.

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value

FDA.C.1.7.1 Local Criteria Report Type

If the primary Product is set to Combination Product or if there are Vaccine-type Case Products, this field auto-generates upon E2B file creation.

Vault populates code 6 when the following Case criteria are met:

Any Case Adverse Event has a Seriousness that includes Death or Life Threatening
The associated Transmission Profile is CDER Study or CBER Study
The Study Type is Clinical Trial
The Report Type is Study or Literature (Study)

Otherwise, Vault uses the following logic to populate this data element:

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	If the Case includes a Combination Product, set to `true`. If there are no Combination Products on the Case, set to `false`.

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 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	For study Cases with a Study Type of Clinical Trial or Individual Patient Use, Vault exports the Study Registration Number based on if the Study is registered with the United States: If the Study has one Study Registration for the United States, Vault exports the Study Registration Number on the Study Registration. If the Study has multiple Study Registrations for the United States, Vault exports the Study Registration Number from the record with the earliest creation date. When cross-reporting for a Study without any Study Registrations for the United States, Vault exports a Study Registration Number from the cross-reported studies associated with a Transmission Study on the Transmission. Vault exports the Study Registration Number from the earliest created Study Registration with Yes in the FDA Primary IND field. If no Study Registrations have Yes in the FDA Primary IND field, Vault exports the Study Registration Number from the cross-reported studies associated with a Transmission Study on the Transmission that includes a Study Registration Number with the earliest created date. For any of the above scenarios, if no Study Registrations include a Study Registration Number, Vault exports this data element as blank.
FDA.C.5.5b Pre-ANDA Number where AE Occurred	The value in the Study Registration Number field if the Transmission Profile associated with the ICSR Transmission is CDER IND Exempt.
FDA.C.5.6.r IND number of cross reported IND	If the suspect product is included in multiple studies, Vault exports Study Registration Numbers for all reportable Study Registrations with a Registration Type of Investigational New Drug (IND) when the Transmission Profile associated with the Transmission is not CDER, CBER, or CDER IND Exempt. Vault creates Transmission Study records for all reportable Study Registrations.

E2B Data Element Name

Populated Value

FDA.C.5.5a IND Number where AE Occurred

For study Cases with a Study Type of Clinical Trial or Individual Patient Use, Vault exports the Study Registration Number based on if the Study is registered with the United States:

If the Study has one Study Registration for the United States, Vault exports the Study Registration Number on the Study Registration.
If the Study has multiple Study Registrations for the United States, Vault exports the Study Registration Number from the record with the earliest creation date.
When cross-reporting for a Study without any Study Registrations for the United States, Vault exports a Study Registration Number from the cross-reported studies associated with a Transmission Study on the Transmission. Vault exports the Study Registration Number from the earliest created Study Registration with Yes in the FDA Primary IND field.
- If no Study Registrations have Yes in the FDA Primary IND field, Vault exports the Study Registration Number from the cross-reported studies associated with a Transmission Study on the Transmission that includes a Study Registration Number with the earliest created date.

For any of the above scenarios, if no Study Registrations include a Study Registration Number, Vault exports this data element as blank.

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

The value in the Study Registration Number field if the Transmission Profile associated with the ICSR Transmission is CDER IND Exempt.

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

If the suspect product is included in multiple studies, Vault exports Study Registration Numbers for all reportable Study Registrations with a Registration Type of Investigational New Drug (IND) when the Transmission Profile associated with the Transmission is not CDER, CBER, or CDER IND Exempt.

Vault creates Transmission Study records for all reportable Study Registrations.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name Populated Value

FDA.D.11.r.1 Patient Race Code

E2B Data Element Name	Populated Value
FDA.D.11.r.1 Patient Race Code	Based on the Race on the Case, Vault populates an NCI Concept Identifier. If the FDA Summary Type in the Details section of the Case is Aggregate or Summary, Vault populates the nullFlavor `NA` in this data element.
FDA.D.12 Patient Ethnicity Code	Based on the Ethnicity on the Case, Vault populates an NCI Concept Identifier. If the FDA Summary Type in the Details section of the Case is Aggregate or Summary, Vault populates the nullFlavor `NA` in this data element.

Based on the Race on the Case, Vault populates an NCI Concept Identifier.

If the FDA Summary Type in the Details section of the Case is Aggregate or Summary, Vault populates the nullFlavor NA in this data element.

FDA.D.12 Patient Ethnicity Code

Based on the Ethnicity on the Case, Vault populates an NCI Concept Identifier.

If the FDA Summary Type in the Details section of the Case is Aggregate or Summary, Vault populates the nullFlavor NA in this data element.

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 ICSR Transmission 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 ICSR Transmission 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 Characterisation of Drug Role	Vault populates `4` to indicate Drug Not Administered in the following instances: For premarket Cases, meaning the Transmission Profile associated with the Transmission is not CDER, CBER, or CDER IND Exempt, the Drug Role of the Case Product is Drug Not Administered For Cases with Combination Products, the Device Report Type includes Malfunction and the Drug Role of the Case Product is Similar Device In all other instances, Vault populates the E2B code from the Drug Role controlled vocabulary corresponding to the value in the Drug Role of the Case Product.
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 not CDER IND Exempt, Vault exports an E2B code based on the Compounding Type of the Case Product as follows: For Bulk Ingredient, Vault exports `3`. For Bulk Ingredient For Human Prescription Compounding, Vault exports `4`. For Unapproved Drug Product Manufactured Exclusively for Private Label Distributer, Vault exports `5`. For any other value or blank, Vault exports nullFlavor `NA`. If the associated Transmission Profile is CDER IND Exempt, Vault exports an E2B code based on the FDA Additional Information On Drug value of the Case Product as follows: For Test, Vault exports `1`. For Reference, Vault exports `2`. For any other value or blank, Vault exports nullFlavor `NA`.
FDA.G.k.10.1 FDA Specialized Product Category	Populated based on the Combination Type value on the Product Registration record.

G.k.4.r Dosage and Relevant Information

E2B Data Element Name	Populated Value
G.k.4.r.7 Batch / Lot Number	The value in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavors are selected.
G.k.4.r.9.1 Pharmaceutical Dose Form (free text)	For postmarket Cases, if the Dose Form Text on the Case Product Dosage maps to a current EDQM term, Vault exports the EDQM Name on the EDQM record. For clinical trial study Cases, or if the value does not map to a current EDQM term, Vault exports the Name on the Case Product Dosage.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	For postmarket Cases, if the Dose Form TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	For postmarket Cases, if the Dose Form TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.10.1 Route of Administration	For postmarket Cases, if the Patient RoA on the Case Product Dosage maps to a current EDQM term, Vault exports the EDQM Name on the EDQM record. For clinical trial study Cases, or if the value does not map to a current EDQM term, Vault exports the Name on the Case Product Dosage.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	For postmarket Cases, if the Patient RoA TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.10.2b Route of Administration TermID	For postmarket Cases, if the Patient RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.11.1 Parent Route of Administration (free text)	For postmarket Cases, if the Parent RoA on the Case Product Dosage maps to a current EDQM term, Vault exports the EDQM Name. For clinical trial study Cases, or if the value does not map to a current EDQM term, Vault exports the Name on the Case Product Dosage.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	For postmarket Cases, if the Parent RoA TermID Version on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Version from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.
G.k.4.r.11.2b Parent Route of Administration TermID	For postmarket Cases, if the Parent RoA TermID on the Case Product Dosage maps to an EDQM term, Vault exports an EDQM Code from an EDQM record using the following priority order: A current EDQM term The most recent, non-current EDQM term For clinical trial study Cases, Vault does not populate this data element.

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	Vault populates a value using the following priority order: The Product Code on the Case Product The Product Code on the Product Registration of the constituent of the Case Product The Product Code on the Product Registration of the associated Combination 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.

N.1 ICH ICSR Transmission Identification (batch wrapper)

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

C.1 Identification of the Case Safety Report

C.1.6 Additional Available Documents Held by Sender

C.1.8 Worldwide Unique Case Identification

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

C.3 Information on Sender of Case Safety Report

C.4.r Literature Reference(s)

C.5 Study Identification

D Patient Characteristics

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

D.2 Age Information

D.7 Relevant Medical History and Concurrent Conditions

D.8.r Relevant Past Drug History

D.9 In case of Death

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

D.10.8.r Relevant Past Drug History of Parent

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

E.i.3.2 Seriousness Criteria at Event Level

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

G.k Drug(s) Information

G.k.2 Drug Identification

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

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

G.k.4.r Dosage and Relevant Information

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

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

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

G.k.12 Device Information

H Narrative Case Summary and Further Information

H.3.r Sender's Diagnosis

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

FDA E2B(R3) Mapping - FDA Regional Mappings

N.1 ICH ICSR Transmission Identification (batch wrapper)

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

C.1 Identification of the Case Safety Report

C.1.8 Worldwide Unique Case Identification

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

C.5 Study Identification

D.10.8.r Relevant Past Drug History of Parent

E.i.3.2 Seriousness Criteria at Event Level

G.k Drug(s) Information

G.k.4.r Dosage and Relevant Information

G.k.12 Device Information