E2B Generation: FDA E2B(R2) 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(R2) 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(R2) Mapping

M.1 ICH ICSR Transmission Identification (batch wrapper)

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

ICH ICSR Message Header (message wrapper)

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

A Administrative and Identification Numbers

A.1 Identification of the Case Safety Report

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

A.2 Primary Source(s) of Information

E2B Data Element Name	Populated Value
A.2.1.1a Reporter's Title	The value entered in the Title field on a Reporter-type Case Contact.
A.2.1.1b Reporter's Given Name	The value entered in the First Name field on a Reporter-type Case Contact.
A.2.1.1c Reporter's Middle Name	The value entered in the Middle Name field on a Reporter-type Case Contact.
A.2.1.1d Reporter's Family Name	The value entered in the Last Name field on a Reporter-type Case Contact.
A.2.1.2a Reporter's Organisation	The value entered in the Organization field on a Reporter-type Case Contact. Any text that exceeds the 60-character limit for this data element is truncated.
A.2.1.2b Reporter's Department	The value entered in the Department field on a Reporter-type Case Contact.
A.2.1.2c Reporter's Street	The value entered in the Street field on a Reporter-type Case Contact.
A.2.1.2d Reporter's City	The value entered in the City field on a Reporter-type Case Contact.
A.2.1.2e Reporter's State or Province	The value entered in the State/Province field on a Reporter-type Case Contact.
A.2.1.2f Reporter's Postcode	The value entered in the Postal Code/Zip Code field on a Reporter-type Case Contact.
A.2.1.3 Reporter's Country Code	The ISO code populated in the Country field on a Reporter-type Case Contact.
A.2.1.4 Qualification	The option selected in the Qualification field on a Reporter-type Case Contact.

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

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

B Information on the Case

B.1 Patient Characteristics

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

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

E2B Data Element Name

Populated Value

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

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

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

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

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

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

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

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

Seriousness criteria at event level

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

B.4 Drug(s) Information

E2B Data Element Name Populated Value

B.4.k.1 Characterisation of Drug Role

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

Drug Role	E2B Code
Suspect	`1`
Concomitant	`2`
Interacting	`3`
Treatment	N/A: Does not map to an E2B code
Drug Not Administered	`1`
Similar Device	`5`

For Combination Products, this value is based on the non-Device Product constituent. When the Combination Product includes a Company Product, the non-Device Product constituent is determined based on Product Registrations, if possible. If the system cannot determine which Product constituent is not a device, both Product constituents are exported to <drug> blocks and the Drug Rule of each constituent is populated.

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

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

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

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

B.4.k.4.1 Authorisation / Application Number

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

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

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

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

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

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

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

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

B.4.k.5.1 Dose (number)

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

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

B.4.k.5.2 Dose (unit)

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

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

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

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

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

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

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

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

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

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

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

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

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

B.4.k.6 Dosage Text

The information entered in the 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:".

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

B.4.k.18.2 Source of Assessment

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

Source Type
Source (text)

B.4.k.18.3 Method of Assessment

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

Method of Assessment
Method (text)

B.4.k.18.4 Result of Assessment

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

Assessment Result (Override)

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

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

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

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

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

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

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

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

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

This field is populated with data from the following sources:

The text entered in the Additional Information (text) field on the Case Product.
The date entered in the Expiration Date field on the non-Combination Case Product. The format exported is "Expiration Date: YYYY-MM-DD". If a partial date was entered in the field, the format is YYYY-MM or YYYY.
If the Blinded field is set to "Yes" on the Case Product, the system appends 'INVESTIGATIONAL' to this element.
If the Drug Role field is set to "Drug not administered" on the Case Product, the system appends 'DRUG NOT ADMINISTERED' to this element.
If the B.4.k.5.6 Cumulative Dose (number) and B.4.k.5.7 Cumulative Dose (unit) values exceed data element character limits, additional text is mapped to this data element, preceded by the label "CUMULATIVE DOSAGE:".

B.5 Narrative Case Summary and Further Information

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

Combination Product Elements

For Combination Product elements, Case Product information is populated for the device-type Product Constituent only.

E2B Data Element Name	Populated Value
A.1.FDA.15 Combination Product Report Flag	If the Combination Product field on the primary Case Product contains a value, this field is set to `1` (Yes).
A.2.1.3.FDA.4 Reporter's Email Address	The value entered in the Email Address field on the Case Contact (Reporter).
B.4.k.2.4.FDA.1a Expiration Date Format	The code for the appropriate format is specified, based on the date entered in the Expiration Date field on the device-type Case Product.
B.4.k.2.4.FDA.1b Expiration Date	The date entered in the Expiration Date field on the device-type Case Product.
B.4.k.2.FDA.5 Product available for evaluation	The value selected in the Device Available field on the device-type Case Product.
B.4.k.2.6.FDA.1a Product return date format	The appropriate format is specified, based on the date entered in the Returned Date field on the device-type Case Product.
B.4.k.2.6.FDA.1b Product return date	The date entered in the Returned Date field on the device-type Case Product.
B.4.k.20.FDA.1 Brand Name	The value entered in the Trade Name field on the Product record associated with the device-type Case Product, to a limit of 80 characters. If the Trade Name is not on the Case Product, it is populated from the Product Registration, if available.
B.4.k.20.FDA.2 Common Device Name	The value entered in the Generic Name field on the Product record associated with the device-type Case Product.
B.4.k.20.FDA.3 Product Code	The value entered in the Product Code field on the Product Registration record associated with the device-type Product Constituent.
B.4.k.20.FDA.4a Device Manufacturer Name	If there is an organization linked to in the Manufacturer field on the corresponding Product record, the name of that organization. Otherwise, this value is mapped from the name of the organization linked to in the Organization field on the Product record.
B.4.k.20.FDA.4b Manufacturer Address	If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the Street field on that Organization record. Otherwise, this value is mapped from the Street field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.4c Manufacturer City	If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the City field on that Organization record. Otherwise, this value is mapped from the City field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.4d Manufacturer State	If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the State field on that Organization record. Otherwise, this value is mapped from the State field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.4e Manufacturer Country	If there is an organization linked to in the Manufacturer field on the corresponding Product record, this value is mapped from the Country field on that Organization record. Otherwise, this value is mapped from the Country field on the Organization record linked to in the Organization field on the Product record.
B.4.k.20.FDA.5 Model Number	The value entered in the Model Number field on the device-type Case Product.
B.4.k.20.FDA.6 Catalog Number	The value entered in the Catalog Number field on the device-type Case Product.
B.4.k.20.FDA.7 Serial Number	The value entered in the Serial Number field on the device-type Case Product.
B.4.k.20.FDA.8 Unique Identifier UDI#	The value entered in the Unique Identifier field on the device-type Case Product.
B.4.k.20.FDA.9a Implant Date Format	The appropriate format is specified, based on the date entered in the Date Implanted field on the device-type Case Product.
B.4.k.20.FDA.9b Implanted Date	The value entered in the Date Implanted field on the device-type Case Product.
B.4.k.20.FDA.10a Explanted Date Format	The appropriate format is specified, based on the date entered in the Date Explanted field on the device-type Case Product.
B.4.k.20.FDA.10b Explanted Date	The value entered in the Date Explanted field on the device-type Case Product.
B.4.k.20.FDA.11a Approximate age of device/product	The value entered in the Device Age - Number field on the device-type Case Product.
B.4.k.20.FDA.11b Approximate age unit of device/product	The unit selected in the Device Age - Unit field on the device-type Case Product.
B.4.k.20.FDA.12 Single Use Device	The value entered in the Single Use field on the device-type Case Product.
B.4.k.20.FDA.13a Device Manufacture Date Format	The appropriate format is specified, based on the date entered in the Manufacture Date field on the device-type Case Product.
B.4.k.20.FDA.13b Device Manufacture Date	The value entered in the Manufacture Date field on the device-type Case Product.
B.4.k.20.FDA.14.1a Recall	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Recall. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Recall.
B.4.k.20.FDA.14.1b Repair	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Repair. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Repair.
B.4.k.20.FDA.14.1c Replace	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Replace. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Replace.
B.4.k.20.FDA.14.1d Relabeling	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Relabeling. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Relabeling.
B.4.k.20.FDA.14.1e Notification	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Notification. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Notification.
B.4.k.20.FDA.14.1f Inspection	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Inspection. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Inspection.
B.4.k.20.FDA.14.1g Patient monitoring	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Patient monitoring. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Patient monitoring.
B.4.k.20.FDA.14.1h Modification/Adjustment	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Remedial Action field on the Case Product is set to Modification/Adjustment. If the field is blank on the Case Product, the system populates this element when the Remedial Action field on the Case is set to Modification/Adjustment.
B.4.k.20.FDA.14.1i Other	For each Combination Product Device Constituent, when the Remedial Action field on the Case Product is set to Other, this element is populated with the text in the associated Remedial Action Other field. If the Remedial Action field is blank on the Case Product, if the Remedial Action field on the Case is set to Other, this element is populated with the text in the associated Remedial Action - Other field.
B.4.k.20.FDA.15 Device Usage	The value entered in the Device Usage Type field on the device-type Case Product.
B.4.k.20.FDA.16 Device Lot Number	The value selected in the Lot Number field on the Product record associated with the device-type Case Product.
B.4.k.20.FDA.17 Malfunction	For each Combination Product Device Constituent, this element is populated with `1` (Yes) when the Malfunction field on the Case Product is set to Yes. If the field is blank on the Case Product, the system populates this element when the Device Report Type field on the Case contains Malfunction.
B.4.k.20.FDA.18.1a Correction	This element is populated with `1` (Yes) when the Device Follow-Up Type field on the Case is set to Correction.
B.4.k.20.FDA.18.1b Additional Information	This element is populated with `1` (Yes) when the Device Follow-Up Type field on the Case is set to Additional Information.
B.4.k.20.FDA.18.1c Response to FDA request	This element is populated with `1` (Yes) when the Device Follow-Up Type field on the Case is set to Response to FDA Request.
B.4.k.20.FDA.18.1d Device Evaluation	This element is populated with `1` (Yes) when the Device Follow-Up Type field on the Case is set to Device Evaluation.
B.4.k.20.FDA.19.1a Evaluation Type	For each Combination Product Device Constituent, the value is mapped from the Case Product Device Code object and populates the following harmonized FDA/IMDRF codes when found: Medical Device Problem Type of Investigation Investigation Finding Investigation Conclusion
B.4.k.20.FDA.19.1b Evaluation Value	This element is populated with the level 1, 2, or 3 harmonized FDA/IMDRF code that was entered on the device-type Case Product.
B.4.k.20.FDA.20 Operator of the Device	The value selected in the Operator of Device field on the Product record associated with the device-type Case Product.