E2B Generation: EMA E2B(R3) Mapping

When you export a Case to an E2B file, either for an outbound Transmission or directly from the Case page, Vault Safety maps all case data and documents to the appropriate E2B data elements. This article describes how Vault maps information to generate EMA E2B(R3) files.

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

EMA E2B(R3) Mapping

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name Populated Value
N.1.1 Types of Message in batch This value is always 1 for ICH ICSR.
N.1.2 Batch Number The value in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier The value in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier The value in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission The value in the Transmission Date field on the Transmission (Submission or Distribution) record. Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

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

E2B Data Element Name Populated Value
N.2.r.1 Message Identifier The value 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 Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier The value in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation If the Case is Approved or Closed, the date in the Approval Date field.
Otherwise, the date and time when the report was generated or transmitted, calculated with full precision down to the second.

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier The value in the UID field on the Case Number object.
C.1.2 Date of Creation The date in the Approval Date field if the Case is Approved or Closed.
If Approval Date is unavailable, the date of report generation or Transmission with a system warning.
Otherwise, the date and time when the report was generated or Transmitted, calculated with full precision down to the second.
C.1.3 Type of Report The appropriate value is populated, based on the option selected in the Report Type field on the Case:
  • 1: Spontaneous
  • 2: Study
  • 3: Other
  • 4: Unknown
C.1.4 Date Report Was First Received from Source For initial and follow-up Cases, the date in the Receipt Date field on the Case.
C.1.5 Date of Most Recent Information for This Report The date in the New Info Date field on the Case.
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report? If the Local Expedited Criteria (case_expedited__v) field on the Transmission (Submission or Distribution) record has a value, Vault uses this value. If this field is not specified on the Transmission, Vault looks at the Expedited field on the Case as follows:
  • If the value is Yes, this element is populated with 1 (expedited).
  • If the value is No, this element is populated with 2 (non-expedited).
  • If the field is blank, this element is populated with NI (no information).

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

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.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name Populated Value
C.1.8.1 Worldwide Unique Case Identification Number The value in the Worldwide UID field on the Case Number object.
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.

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 Populates the State/Province field on the Case Contact object for the primary reporter.

For domestic Cases, Vault checks if the state or province is mapped to a domestic state code on a Country State/Province record. If a record exists, the Domestic State Code is exported to this field. This is useful for countries, such as Spain or Italy, where the state code is required in submissions to the EMA. If no mapping exists, the text value entered in the State/Province field is exported to this element.
C.2.r.2.6 Reporter's Postcode The value 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.
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 Transmission (Submission or Distribution) record.
If the Sender User is not specified on the Transmission, by default Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization

The value in the Organization field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.

If the Sender User is not specified on the Transmission, by default Vault maps the Organization on the Case.

Any text that exceeds the 100-character limit for this data element is truncated.
C.3.3.1 Sender's Department The value in the Department field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.2 Sender's Title The value in the Title field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name The value in the First Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name The value in the Middle Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name The value in the Last Name field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address The value in the Street field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City The value in the City field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province The value in the State / Province field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode The value in the Zip/Postal Code field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code The 2-letter ISO code associated with the country selected in the Country field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone The value in the Telephone field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax The value in the Fax field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.8 Sender's E-mail Address The value in the Email field in the User record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name Populated Value
C.4.r.1 Literature Reference(s)

The value 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 the Vancouver Citation value on the Literature Article record to this data element. 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

When generating EMA E2B(R3) Submissions and Distributions, the value in the Report Type field of the Case may be overridden by the Report Type Override field on the Transmission record. This is useful, for example, when a Clinical Trial Case involves adverse events related solely to non-investigational medicinal products available in the EU. If the Report Type Override field is set to Spontaneous, the C.5 Study Identification block is not generated.

E2B Data Element Name Populated Value
C.5.1.r.1 Study Registration Number The value in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object.

For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name The values in the Study Name and Study Name (Continued) fields on the associated Case, to a limit of 2,000 characters.
C.5.3 Sponsor Study Number The value in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed The value in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name Populated Value
D.1 Patient (name or initials) The value 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 in the Date of Birth field on the Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.2.2a Age at Time of Onset of Reaction / Event (number) The value in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit) The value in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number) The value in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit) The unit in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter) The 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 object.
D.7.1.r.2 Start Date The date in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date The date in the End Date field on the Case Medical History object.
D.7.1.r.5 Comments The text in the Comments field on the Case Medical History object, to a limit of 2,000 characters.
D.7.1.r.6 Family History The value in the Family History field on the Case Medical History object.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) The text in the Medical History Text field on the Case, to a limit of 10,000 characters.
D.7.3 Concomitant Therapies Set to True when the Concomitant Therapies field is set to Yes on the Case.

D.8.r Relevant Past Drug History

E2B Data Element Name Populated Value
D.8.r.1 Name of Drug as Reported The value in the Drug (Reported) field on the Case Drug History record.
D.8.r.2a MPID Version Date/Number The value in the MPID Version field on the Case Drug History record.
D.8.r.2b Medicinal Product Identifier (MPID) The value in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number The value in the PhPID Version field on the Case Drug History record.
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.8.r.1 Name of Drug as Reported

E2B Data Element Name Populated Value
D.8.r.1.EU.1 Name part - Invented name The value in the Invented Name Part field on the Case Drug History object.
D.8.r.1.EU.2 Name part - Scientific name The value in the Scientific Name Part field on the Case Drug History object.
D.8.r.1.EU.3 Name part - Trademark name The value in the Trademark Name Part field on the Case Drug History object.
D.8.r.1.EU.4 Name part - Strength name The value in the Strength Name Part field on the Case Drug History object.
D.8.r.1.EU.5 Name part - Form name The value in the Form Name Part field on the Case Drug History object.
D.8.r.1.EU.6 Name part - Container name The value in the Container Name Part field on the Case Drug History object.
D.8.r.1.EU.7 Name part - Device name The value in the Device Name Part field on the Case Drug History object.
D.8.r.1.EU.8 Name part - Intended use name The value in the Intended Use Name Part field on the Case Drug History object.

D.8.r.EU Substance / Specified Substance Identifier and Strength

E2B Data Element Name Populated Value
D.8.r.EU.r.1 Substance / Specified Substance Name The value in the Name (Reported) field on the Case Drug History Substance.
D.8.r.EU.r.2a Substance/Specified Substance TermID Version Date/Number The value in the TermID Version field on the Case Drug History Substance.
D.8.r.EU.r.2b Substance/Specified Substance TermID The value in the TermID field on the Case Drug History Substance.
D.8.r.EU.r.3a Strength (number) The value in the Strength (Number) field on the Case Drug History Substance.
D.8.r.EU.r.3b Strength (unit) The unit selected in the Strength (Unit) field on the Case Drug History Substance.

D.9 In case of Death

E2B Data Element Name Populated Value
D.9.1 Date of Death The date 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 value in the Patient ID field on the associated Parent Information Case.
D.10.2.1 Date of Birth of Parent The date in the Date of Birth field on the associated Parent Information Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number) The value in the Age field on the associated Parent Information Case.
D.10.2.2b Age of Parent (unit) The unit in the Age (unit) field on the associated Parent Information Case.
D.10.3 Last Menstrual Period Date of Parent The date in the Last Menstrual field on the associated Parent Information Case.
D.10.4 Body Weight (kg) of Parent The value in the Weight field on the associated Parent Information Case.
D.10.5 Height (cm) of Parent The value in the Height (normalized) field on the associated Parent Information Case.
D.10.6 Sex of Parent The value in the Sex field on the associated Parent Information Case.
D.10.7.1.r.1a MedDRA Version for Medical History Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) The MedDRA LLT coded on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.2 Start Date The date in the Start Date field on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.3 Continuing The value in the Continuing field on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.4 End Date The date in the End Date field on the Case Medical History object on the associated Parent Information Case.
D.10.7.1.r.5 Comments The text in the Comments field on the Case Medical History object on the associated Parent Information Case, 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 Case, to a limit of 10,000 characters.

D.10.8.r Relevant Past Drug History of Parent

E2B Data Element Name Populated Value
D.10.8.r.1 Name of Drug as Reported The text in the Name Reported field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.2a MPID Version Date/Number The value in the MPID Version field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.2b Medicinal Product Identifier (MPID) The value in the MPID field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.3a PhPID Version Date/Number The value in the PhPID Version field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.4 Start Date The date in the Start Date field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.5 End Date The date in the End Date field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.6a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.
D.10.8.r.6b Indication (MedDRA code) The indication MedDRA LLT coded on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.7a MedDRA Version for Reaction Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.
D.10.8.r.7b Reactions (MedDRA code) Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information Case.

D.10.8.r.1 Relevant Past Drug History of Parent

E2B Data Element Name Populated Value
D.10.8.r.1.EU.1 Name part - Invented name The value in the Invented Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.2 Name part - Scientific name The value in the Scientific Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.3 Name part - Trademark name The value in the Trademark Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.4 Name part - Strength name The value in the Strength Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.5 Name part - Form name The value in the Form Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.6 Name part - Container name The value in the Container Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.7 Name part - Device name The value in the Device Name Part field on the Case Drug History object on the associated Parent Information Case.
D.10.8.r.1.EU.8 Name part - Intended use name The value in the Intended Use Name Part field on the Case Drug History object on the associated Parent Information Case.

D.10.8.r.EU Substance / Specified Substance Identifier and Strength

E2B Data Element Name Populated Value
D.10.r.EU.r.1 Substance / Specified Substance Name The value in the Name (Reported) field on the Case Drug History Substance object on the associated Parent Information Case.
D.10.8.r.EU.r.2a Substance/Specified Substance TermID Version Date/Number The value in the TermID Version field on the Case Drug History Substance object on the associated Parent Information Case.
D.10.8.r.EU.r.2b Substance/Specified Substance TermID The value in the TermID field on the Case Drug History Substance object on the associated Parent Information Case.
D.10.8.r.EU.r.3a Strength (number) The value in the Strength (Number) field on the Case Drug History Substance object on the associated Parent Information Case.
D.10.8.r.EU.r.3b Strength (unit) The unit selected in the Strength (Unit) field on the Case Drug History Substance object on the associated Parent Information Case.

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

E2B Data Element Name Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language The text in the Event (Reported) field on the Case Adverse Event.
E.i.1.1b Reaction / Event as Reported by the Primary Source Language The text in the Event (Reported) - Language field on the Case Adverse Event.
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation The text in the Event (Reported) - English (event_reported_english__v) field on the Case Adverse Event.
E.i.2.1a MedDRA Version for Reaction / Event Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code) The value in the Event (MedDRA) field 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.
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.
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.
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 The value in the Drug Role field on the Case Product record.
G.k.2.4 Identification of the Country Where the Drug Was Obtained The value 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.
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 value in the MPID Version field on the Case Product record.
G.k.2.1.1b Medicinal Product Identifier (MPID) The value in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number The value in the PhPID Version field on the Case Product record.
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.2.2.EU.9.r.1 Device Component Name The value in the Product (Reported) field on the Case Product record for a device constituent in a Combination Product.
G.k.2.2.EU.9.r.4 Device Batch Lot Number The value in the Lot Number field on the Case Product record for a device constituent in a Combination Product.

G.k.2.2 Medicinal Product Name as Reported by the Primary Source

E2B Data Element Name Populated Value
G.k.2.2.EU.1 Name part - Invented name The value in the Invented Name Part field on the Case Product record.
G.k.2.2.EU.2 Name part - Scientific name The value in the Scientific Name Part field on the Case Product record.
G.k.2.2.EU.3 Name part - Trademark name The value in the Trademark Name Part field on the Case Product record.
G.k.2.2.EU.4 Name part - Strength name The value in the Strength Name Part field on the Case Product record.
G.k.2.2.EU.5 Name part - Form name The value in the Form Name Part field on the Case Product record.
G.k.2.2.EU.6 Name part - Container name The value in the Container Name Part field on the Case Product record.
G.k.2.2.EU.7 Name part - Device name The value in the Device Name Part field on the Case Product record.
G.k.2.2.EU.8 Name part - Intended use name The value in the Intended Use Name field on the Case Product record.

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

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

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

E2B Data Element Name Populated Value
G.k.3.1 Authorisation / Application Number

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

If the Registration Country is not in the jurisdiction of the agency, this data element is blank.
G.k.3.2 Country of Authorisation / Application

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

If the Registration Country is not in the jurisdiction of the agency or is blank, this data element is blank.
G.k.3.3 Name of Holder / Applicant

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

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

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 value in the Duration (number) field 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 transmitted with nullFlavours when the following Reason Omitted values are set:

  • Blank or Unknown: UNK
  • Masked: MSK
  • Asked But Unknown: ASKU
G.k.4.r.8 Dosage Text The value in the Dosage Text field on the Case Product Dosage. When a custom value is entered in the Dose (Unit) field, the Dose and Dose (Unit) values are mapped to this element, preceded by the label "DOSAGE:".
G.k.4.r.9.1 Pharmaceutical Dose Form (free text) If the Dose Form Text field value maps to a current EDQM Term, the EDQM Name field is exported. If the field value does not map to a current EDQM Term, the Name field is exported.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number If the Dose Form TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID If the Dose Form TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.10.1 Route of Administration If the Patient RoA field value maps to a current EDQM Term, the EDQM Name field is exported. If the field value does not map to a current EDQM Term, the Name field is exported.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number If the Patient RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.10.2b Route of Administration TermID If the Patient RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.11.1 Parent Route of Administration (free text) If the Parent RoA field value maps to a current EDQM Term, the EDQM Name field is exported. If the field value does not map to a current EDQM Term, the Name field is exported.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number If the Parent RoA TermID Version field value maps to a current EDQM Term, the EDQM Version field is exported. If the field value does not map to a current EDQM Term, Vault does not populate this data element.
G.k.4.r.11.2b Parent Route of Administration TermID If the Parent RoA TermID field value maps to a current EDQM Term, the EDQM Code field is exported. If the field value does not map to a current EDQM Term, 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

E2B Data Element Name Populated Value
G.k.9.i.1 Reaction(s) / Event(s) Assessed The specific reaction or event being assessed, referenced in the Case Adverse Event field on the Case Assessment. This is not a user-entered element.
G.k.9.i.3.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) The value in the First Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit) The unit in the First Dose Latency (unit) field on the Case Assessment.
G.k.9.i.3.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number) The value in the Last Dose Latency (number) field on the Case Assessment.
G.k.9.i.3.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit) The unit 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 reccurred)
  • 2: yes - no (rechallenge was done, reaction did not recur)
  • 3: yes - unk (rechallenge was done, outcome unknown)
  • 4: no - n/a (no rechallenge was done, recurrence is not applicable)

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

E2B Data Element Name Populated Value
G.k.9.i.2.r.1.EU.1 EU Source of Assessment Vault maps this value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. Vault first attempts to map the E2B code corresponding to the Source Type Controlled Vocabulary.
  2. If Vault cannot map the E2B code, Vault maps the free text value from the Source (text) field.
G.k.9.i.2.r.1 Source of Assessment Vault maps this value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. Vault first attempts to map the E2B code corresponding to the Source Type Controlled Vocabulary.
  2. If Vault cannot map the E2B code, Vault maps the free text value from the Source (text) field.
G.k.9.i.2.r.2 Method of Assessment Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. Vault first attempts to map the picklist value corresponding to the Method of Assessment Controlled Vocabulary.
  2. If no Method of Assessment Controlled Vocabulary value was selected, Vault maps the free text value from the Method (text) field.
G.k.9.i.2.r.2.EU.1 EU Method of Assessment If the Method of Assessment field on the Case Assessment Result record references a Controlled Vocabulary with the picklist value EU Method of Assessment, Vault exports the corresponding E2B code. Otherwise, Vault maps the value in the Method (text) field.
G.k.9.i.2.r.3 Result of Assessment Vault maps a text value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. If enabled, the value is mapped from the Assessment Result (Override) field.

  2. Vault otherwise attempts to map the E2B code corresponding to the Assessment Result Controlled Vocabulary.
  3. If Vault cannot map the E2B code, Vault maps the free text value from the Result (text) field.
G.k.9.i.2.r.3.EU.1 EU Result of Assessment Vault maps the value from one of the following fields on the Case Assessment Result, ordered by priority:
  1. Vault first attempts to map the E2B code corresponding to the Assessment Result (Override) Controlled Vocabulary. If no E2B code is specified, Vault finds the record Name of the Assessment Result (Override) Controlled Vocabulary.
  2. If the Assessment Result (Override) is not available, Vault attempts to map the E2B code corresponding to the Assessment Result Controlled Vocabulary.
    If no E2B code is specified, Vault finds the record Name of the Assessment Result Controlled Vocabulary.
  3. If none of the above are available, Vault maps the free text value from the Result (text) field.

H Narrative Case Summary and Further Information

E2B Data Element Name Populated Value
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information The text from the Narrative on the Case, to a limit of 100,000 characters.
H.2 Reporter's Comments The text from the Reporter's Comments field on the Case, to a limit of 20,000 characters.
H.4 Sender's Comments The 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 If there is a Case document classified with the Case > Summary > Narrative, the contents of that document is populated in this element, to a limit of 100,000 characters.

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

This information is separate from the data captured by H.2 Reporter's Comments.
H.5.r.1b Case Summary and Reporter's Comments Language The 3-letter ISO code from the Language (ISO) document field for the Case document classified with the Case > Summary >Narrative.

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

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