E2B Generation Data Mapping: ICH E2B(R2)

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 ICH E2B(R2) files.

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

ICH E2B(R2) Mapping

M.1 ICH ICSR Transmission Identification (batch wrapper)

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

ICH ICSR Message Header (message wrapper)

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

A Administrative and Identification Numbers

A.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value
A.1.0.1 Sender's (case) Safety Report Unique Identifier The value entered in the UID field on the Case Number object is populated in this element. Also, if the Safety Report Version field is populated on the Transmission (Submission or Distribution), then the <safetyreportversion> tag is populated with the text entered in the field.
A.1.1 Reporter's Country Code The ISO code populated in the Country field on the Reporter-type Case Contact.
A.1.2 Identification of the Country Where the Reaction / Event Occurred The value entered in the Event Country field on the primary Case Adverse Event.
A.1.3b Date of Transmission If the Case is Approved or Closed, the date entered in the Approval Date field.
Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.
A.1.4 Type of Report The appropriate value is populated, based on the option selected in the Report Type field on the Case
  • 1: Spontaneous
  • 2: Study
  • 3: Other
  • 4: Unknown
A.1.5.1 Serious Set to 1 (Yes) if there is at least one Case Adverse Event with seriousness criteria.
A.1.5.2 Seriousness Criteria Populated with seriousness tags corresponding to the criteria selected in the Seriousness field across all Case Adverse Events. A seriousness criteria tag is set to 1 (Yes) if there is at least one Case Adverse Event with that seriousness criteria.
A.1.6 Date Report Was First Received from Source
  • For initial Cases, the date entered in the Receipt Date field on the Case.
  • For Follow-Up Cases, the date entered in the Initial Receipt Date field on the Case.
A.1.7 Date of Most Recent Information for This Report The date entered in the New Info Date field on the Case.
A.1.8.1 Are Additional Documents Available Populated as True if there are documents attached to the Case with the document type of Case > Source > Attachment.
A.1.8.2 Documents Held by Sender The text entered in the Attachment Description and Attachment Description Continued fields on any documents attached to the Case with the document type of Case > Source > Attachment, to a limit of 2,000 characters.
A.1.9 Does this case fulfill the local criteria for an expedited report If the Local Expedited Criteria (case_expedited__v) field on the Transmission (Submission or Distribution) record has a value, the system uses this value. If this field is not specified on the Transmission, the system looks at the Expedited field on the Case.

If the value is Yes, this element is populated with 1 (expedited). Otherwise, this element is populated with 2 (non-expedited).
A.1.10.1 Regulatory authority's case report number The value entered in the Worldwide UID field on the Case Number object.
A.1.10.2 Other sender's case report number The value entered in the First Sender field on the original inbound Transmission.

The Transmission Date is used to find the original Transmission.
A.1.11 Other Case Identifiers in Previous Transmissions Populated as True if there are any Case Identifier objects associated with the Case.
A.1.11.1 Source(s) of the Case Identifier The value entered in the Source field on the Case Identifier object.

This element is transmitted only when the Case Identifier Type (type__v) is set to Re-Transmittable or is blank.
A.1.11.2 Case Identifier(s) The value entered in the Case Identifier field on the Case Identifier object.

This element is transmitted only when the Case Identifier Type (type__v) is set to Re-Transmittable or is blank.
A.1.12 Identification Number of the Report Which Is Linked to This Report The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
A.1.13 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 User record associated with the Sender User on the Transmission (Submission or Distribution) record.
If the Sender User is not specified on the Transmission, by default the system maps the Organization on the Case.
A.3.1.3a Sender's Department The value entered in the Department field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3b Sender's Title The value entered in the Title field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3c Sender's Given Name The value entered in the First Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3d Sender's Middle Name The value entered in the Middle Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.3e Sender's Family Name The value entered in the Last Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4a Sender's Street Address The value entered in the Street field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4b Sender's City The value entered in the City field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4c Sender's State or Province The value entered in the State / Province field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.3.1.4d Sender's Postcode The value entered in the Postal Code / Zip Code field in the User 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 User 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 User 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 User 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 User record associated with the Sender User on the Transmission (Submission or Distribution) record.
A.2.2 Literature Reference(s) The value entered in the Reference document field for any Case documents classified with the Case > Source > Literature document type, to a limit of 500 characters.
A.2.3.1 Study Name For FDA and ICH E2B R2, the values entered in the Study Name and Study Name (Continued) fields on the associated Study, to a limit of 2,000 characters.
A.2.3.2 Sponsor Study Number The value entered in the Study Number field on the associated Study.
A.2.3.3 Study Type Where Reaction(s) / Event(s) Were Observed The option populated in the Study Type (product_usage_reason__v) field on the Case.
A.3.2.1 Receiver Type The option selected in the Receiver Type field of the Receiver Person record on the Transmission Profile record. If a Receiver Person is not specified, the system maps the Sender Type from the Destination Organization on the Transmission Profile.

Per E2B(R2) guidelines, only the following values are mapped:

  • 1: Pharmaceutical company
  • 2: Regulatory authority
  • 4: Regional pharmacovigilance center
  • 5: WHO collaborating center for international drug monitoring
A.3.2.2a Receiver's Organisation The value entered in the Organization field of the Receiver Person record on the Transmission Profile record. If a Receiver Person is not specified on the Transmission Profile, the system maps the value in the Destination ID field on the Transmission Profile.
A.3.2.2b Receiver's Department The value entered in the Department field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2c Receiver's Title The value entered in the Title field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2d Receiver's Given Name The value entered in the First Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2e Receiver's Middle Name The value entered in the Middle Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.2f Receiver's Family Name The value entered in the Last Name field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3a Receiver's Street Address The value entered in the Street field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3b Receiver's City The value entered in the City field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3c Receiver's State or Province The value entered in the State / Province field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3d Receiver's Postcode The value entered in the Postal Code / Zip Code field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3e Receiver's Country Code The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3f Receiver's Telephone The value entered in the Telephone field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3g Receiver's Telephone Extension The value entered in the Telephone Extension field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3h Receiver's Telephone Country The value entered in the Telephone Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3i Receiver's Fax The value entered in the Fax field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3j Receiver's Fax Extension The value entered in the Fax Extension field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3k Receiver's Fax Country The value entered in the Fax Country field in the Person record associated with the Receiver Person on the Transmission Profile record.
A.3.2.3l Receiver's E-mail Address The value entered in the Email field in the Person record associated with the Receiver Person on the Transmission Profile record.

B Information on the Case

B.1 Patient Characteristics

E2B Data Element Name Populated Value
B.1.1 Patient initials The value in the Patient Initials / ID field on the Case.
B.1.1.1a GP medical record number The value in the MRN - GP field on the Case.
B.1.1.1b Specialist record number The value in the MRN - Specialist field on the Case.
B.1.1.1c Hospital record number The value in the MRN - Hospital field on the Case.
B.1.1.1d Investigation number The value in the MRN - Investigation field on the Case.
B.1.2.1 Date of birth The date in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
B.1.2.2a Age at time of onset of reaction/event (number) The value in the Age field on the Case. In accordance with ICH guidelines, this element is 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 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 in the Weight field on the Case, normalized to the accepted unit.
B.1.4 Height (cm) The value in the Height field on the Case, normalized to the accepted unit.
B.1.5 Sex The option populated in the Gender field on the Case.
B.1.6 Last menstrual period date The date 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 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 in the End Date field on the Case Medical History object.
B.1.7.1g Comments The text in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
B.1.7.2 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.
B.1.8a Name of Drug as Reported The value in the Name Reported field on the Case Drug History object.
B.1.8c Start date The date in the Start Date field on the Case Drug History object.
B.1.8e End Date The value 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 in the Reaction MedDRA field on the Case Drug History object.
B.1.9.1 Date of Death The date in the Date of Death field on the Case.
B.1.9.2a MedDRA Version for Reported Cause(s) of Death Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.9.2b Reported Cause(s) of Death (MedDRA code) This field is exported from one of the following sources from the Reported Case Cause of Death record, ordered by priority:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. If a coded term is unavailable, the Cause of Death (Reported) (name_reported__v) field is exported.
B.1.9.3 Was Autopsy Done? The value selected in the Autopsy field on the Case.
B.1.9.4a MedDRA Version for Autopsy-determined Cause(s) of Death Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
B.1.9.4b Autopsy-determined Cause(s) of Death (MedDRA code) This field is exported from one of the following sources from the Autopsy-Determined Case Cause of Death record, ordered by priority:
  1. If the Cause of Death (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. If a coded term is unavailable, the Cause of Death (Reported) (name_reported__v) field is exported.
B.1.10.1 Parent Identification The value in the Patient ID field on the associated Parent-type Case.
B.1.10.2.1 Date of Birth of Parent The date 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 in the Age field on the associated Parent Information Case.
B.1.10.2.2b Age of Parent (unit) The unit in the Age (unit) field on the associated Parent Information 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:
  1. If the Name MedDRA (LLT) (name_meddra__v) field is coded, the MedDRA code is exported.
  2. If a coded term is unavailable, the Test Name (Reported) (name_reported__v) field is exported.
B.3.1d Result The value entered in the Test Result (Qualifier) and Test Result (Number) fields on the Case Test Result.
B.3.1e Test Result (unit) The unit selected in the Result (Unit) field on the Case Test Result.
B.3.1.1 Normal Low Value The unit and value entered in the Normal Low Value field on the Case Test Result.
If the result does not have a unit, the system will map any text entered instead.
B.3.1.2 Normal High Value The unit and value entered in the Normal High Value field on the Case Test Result.
If the result does not have a unit, the system will map any text entered instead.
B.3.1.3 More Information Available

The value entered in the More Information Available field on the Case Test Result.

If Vault truncates any values mapped to the B.3.2 Results of tests and procedures relevant to the investigation of the patient data element due to character limitations, Vault populates this data element with 1 (Yes).
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.

B.4 Drug(s) Information

E2B Data Element Name Populated Value
B.4.k.1 Characterisation of Drug Role

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

Drug Role E2B Code
Suspect 1
Concomitant 2
Interacting 3
Treatment N/A: Does not map to an E2B code
Drug Not Administered 1
B.4.k.2.1 Medicinal Product Name as Reported by the Primary Source The information entered in the Product (Reported) field on the Case Product.
B.4.k.2.2 Substance / Specified Substance Name The information entered in the Name (Reported) field on the Case Product Substance.
B.4.k.2.3 Identification of the Country Where the Drug Was Obtained The value entered in the Country Obtained field on the Case Product.
Investigational Product Blinded The value entered in the Blinded field on the Case Product.
B.4.k.4.1 Authorisation / Application Number

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

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
B.4.k.4.2 Country of Authorisation / Application

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

If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
B.4.k.4.3 Name of Holder / Applicant

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

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
B.4.k.5.1 Dose (number) The value entered in the Dose (number) field on the Case Product Dosage.

If the value exceeds character limits, additional text is mapped to B.4.k.6 Dosage Text.
B.4.k.5.2 Dose (unit) The unit selected in the Dose (unit) field on the Case Product Dosage.

If the value exceeds character limits, additional text is mapped to B.4.k.6 Dosage Text.
B.4.k.5.3 Number of separate dosages Set to the number of individual Case Product Dosage records associated with the Case.
B.4.k.5.4 Number of Units in the Interval The value entered in the Frequency field on the Case Product Dosage.

For FDA and ICH E2B R2 only, when a non-standard frequency measurement (cyclical, as necessary, or total) is specified in the Frequency field, this element is left blank and the non-standard unit is populated in data element B.4.k.6.
B.4.k.5.5 Definition of the Time Interval Unit The appropriate E2B(R2) code is mapped based on the unit selected in the Frequency field on the Case Product Dosage.

For FDA and ICH E2B R2 only, when a non-standard frequency measurement (cyclical, as necessary, or total) is specified in the Frequency field, this element is left blank and the non-standard unit is populated in data element B.4.k.6.
B.4.k.12 Date and Time of Start of Drug The information entered in the First Administration field on the Case Product Dosage.
B.4.k.14 Date and Time of Last Administration The information entered in the Last Administration field on the Case Product Dosage.
B.4.k.15a Duration of Drug Administration (number) The value entered in the Duration (number) field on the Case Product Dosage.
B.4.k.15b Duration of Drug Administration (unit) The unit selected in the Duration (unit) field on the Case Product Dosage.
B.4.k.3 Batch / Lot Number The information entered in the Batch/Lot Number field on the Case Product Dosage.
B.4.k.6 Dosage Text

The information entered in the 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:
  1. Source Type
  2. Source (text)
B.4.k.18.3 Method of Assessment The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. Method of Assessment
  2. Method (text)
B.4.k.18.4 Result of Assessment The system maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. Assessment Result (Override)
  2. Assessment Result
  3. Result (text)
B.4.k.13.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) The value entered in the First Dose Latency (number) field on the Case Assessment.
B.4.k.13.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit) The unit selected in the First Dose Latency (unit) field on the Case Assessment.
B.4.k.13.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number) The value entered in the Last Dose Latency (number) field on the Case Assessment.
B.4.k.13.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit) The unit selected in the Last Dose Latency (unit) field on the Case Assessment.
B.4.k.17.1 Did Reaction Recur on Re-administration? The appropriate value is populated, based on the option selected in the Reaction Recurrence field on the Case Assessment:
  • 1: yes - yes (rechallenge was done, reaction reccurred)
  • 2: 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 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 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.