# E2B Generation: PMDA 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 PMDA E2B(R3) files. For details about all other E2B formats supported by Vault, see E2B Generation Data Mapping. For details about other PMDA report formats, see PMDA MHLW Paper Form Generation Data Mapping.
## PMDA E2B(R3) Mapping
Per PMDA guidance, certain data elements are transmitted only for specific PMDA Reporting Categories (J2.1a). The PMDA Reporting Categories for which each element is transmitted are outlined in the following Excel file: Data Transmitted by PMDA Reporting Category The following tables define how each E2B data element is mapped for a PMDA E2B(R3) file. Use [the section below][1] to review only regional PMDA mappings that are different from the ICH mappings.

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name Populated Value
N.1.1 Types of Message in batch This value is always 1 for ICH ICSR.
N.1.2 Batch Number The value in the E2B Message ID field on the ICSR Transmission.
N.1.3 Batch Sender Identifier The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission.
N.1.4 Batch Receiver Identifier The value in the Destination ID field on the Transmission Profile associated with the ICSR Transmission.
N.1.5 Date of Batch Transmission The value in the Transmission Date field on the ICSR Transmission. Otherwise, the date and time when the report was generated or transmitted. The time is converted to Japan Standard Time (JST) and transmitted in the format CCYYMMDDhhmmss+0900.

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

E2B Data Element Name Populated Value
N.2.r.1 Message Identifier

For PMDA, Vault generates this value during E2B generation using the following fields:

(case_version__v.reporter_country__v.abbreviation_2__v)
(transmission_profile__v.origin_id__v)
(local_reporting_details__v.report_uid__v)

For example: JP-VertBio-000001AB

PMDA requires that when multiple ICSRs are submitted from a single Case, N.2.r.1 and C.1.1 must be different for each ICSR.

To achieve this, Vault Safety adds logic to append suffix (AA-ZZ) to the existing UID generation logic to make it unique per submission. The generated UID is stored in the Report UID field of the Local Reporting Details (local_reporting_details__v.report_uid__v) record.
N.2.r.2 Message Sender Identifier The value in the Origin ID field on the Transmission Profile associated with the ICSR Transmission.
N.2.r.3 Message Receiver Identifier The value in the Destination ID field on the Transmission Profile associated with the ICSR Transmission.
N.2.r.4 Date of Message Creation The exact date and time when the report was generated, in the format CCYYMMDDhhmmss+0900. The time is converted to Japan Standard Time (JST).

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier

For PMDA, Vault generates this value during E2B generation using the following fields:

(case_version__v.reporter_country__v.abbreviation_2__v)
(transmission_profile__v.origin_id__v)
(local_reporting_details__v.report_uid_v)

For example: JP-VertBio-000001AB

See N.2.r.1 for unique report UID generation.
C.1.2 Date of Creation The exact date and time when the report was generated, in the format CCYYMMDDhhmmss+0900. The time is converted to Japan Standard Time (JST).
C.1.3 Type of Report Vault populates a code based on the Report Type of the Case:
  • 1: Spontaneous
  • 2: Study
  • 3: Other
  • 4: Unknown
C.1.4 Date Report Was First Received from Source
  • For initial Cases, the date in the Local Initial Receipt Date field on the Localized Case. If blank, the date in the Receipt Date field on the Global Case is exported.
  • For Follow-Up Cases, the date in the Local Initial Receipt Date field on the Localized Case. If blank, the date in the Initial Receipt Date field on the Global Case is exported.

The time is converted to Japan Standard Time (JST).
C.1.5 Date of Most Recent Information for This Report The date in the Local New Info Date field on the Localized Case. If blank, the date in the New Info Date field from the Global Case is exported. The time is converted to Japan Standard Time (JST).
C.1.7 Does This Case Fulfil the Local Criteria for an Expedited Report? If the Local Expedited Criteria (case_expedited__v) field on the ICSR Transmission has a value, Vault uses this value. If this field is not specified on the Transmission, Vault looks at the Expedited field on the Case. If the value is Yes, Vault populates this element with 1 (expedited). Otherwise, Vault populates this element with 2 (non-expedited).

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

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 For documents with the Case > Source > Attachment document type, Vault attempts to populate the Attachment Description from the Localized Case Document that is linked to the document, to a limit of 2,000 characters. If unavailable, Vault populates the Description from the global Case Document.
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 domestic Cases or Localized Cases with previous Transmissions that included the attachment to the same reporting destination.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name Populated Value
C.1.8.1 Worldwide Unique Case Identification Number The Worldwide UID on the Case Version.
C.1.8.2 First Sender of This Case The value in the First Sender field on the original Inbound Transmission.

The transmission date is used to find the original Transmission.
C.1.9.1 Other Case Identifiers in Previous Transmissions Populated as True if there are any Case Identifier objects associated with the Case. If there are no Case Identifier objects associated with the Case, NI is exported.
C.1.9.1.r.1 Source(s) of the Case Identifier Repeated for the value in the Source field on each Localized Case Identifier object under the Japanese Localized Case.

This element is transmitted only when the Case Identifier Type (type__v) is set to Re-Transmittable or is blank.

localized_case_identifier__v.source__v
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.3 Reporter's Country Code The ISO code in the Country field on the primary Reporter-type Case Contact. This field is transmitted only if C.2.r.5 is set to 1 (Primary Source) for the corresponding Reporter-type Case Contact.
C.2.r.4 Qualification The value in the Qualification field on a Reporter-type Case Contact. If Patient or Parent is selected in this field, then the E2B code of 5 is mapped.
C.2.r.5 Primary Source for Regulatory Purposes Populated with 1 (true) if the Primary Source field is set to Yes on the associated Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name Populated Value
C.3.1 Sender Type The value in the Sender Type field in the Organization record associated with the Sender (User) on the ICSR Transmission.
If the Sender (User) is not specified on the Transmission, Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization The Organization in the Origin field on the PMDA Transmission Profile. transmission_profile__v.origin_transmission_id__v
C.3.3.2 Sender's Title The value in the Title field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.3 Sender's Given Name The value in the First Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.4 Sender's Middle Name The value in the Middle Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.3.5 Sender's Family Name The value in the Last Name field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.1 Sender's Street Address The value in the Street field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.2 Sender's City The value in the City field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.3 Sender's State or Province The value in the State / Province field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.4 Sender's Postcode The value in the Zip/Postal Code field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.5 Sender's Country Code The 2-letter ISO code associated with the country selected in the Country field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.6 Sender's Telephone The value in the Telephone field in the User record associated with the Sender (User) on the ICSR Transmission.
C.3.4.7 Sender's Fax The value in the Fax field in the User record associated with the Sender (User) on the ICSR Transmission.

C.4.r Literature Reference(s)

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

For Case attachments with the document type Case > Source > Literature, Literature > Literature Article > Summary and Literature > Literature Article > Full-text, Vault retrieves the corresponding Japan Localized Case Document and populates this element with the value in the Reference field to a limit of 500 characters.

For Case attachments with the document type Literature > Literature Article and for each document identified in the J2.15.r Country of Publication data element, Vault maps a value using the following priority order:

  • The Reference field value from the Localized Case Document
  • The value from the C.4.r.1 data element on the E2B file for the global Case
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 domestic Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

C.5 Study Identification

E2B Data Element Name Populated Value
C.5.1.r.1 Study Registration Number The Registration Number on the Case Study Registration.
C.5.1.r.2 Study Registration Country The 2-letter ISO code associated with the Country on the Case Study Registration.
C.5.2 Study Name

The value in the Study Name field on the Localized Study for Japan associated with the Study on the global Case.

If there is no Localized Study for Japan, Vault exports the value in the Study Name field on the associated global Case.
C.5.3 Sponsor Study Number The Study Number on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed Based on the Study Type on the Case, Vault populates an E2B code corresponding to the Study Type controlled vocabulary.

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) This element is transmitted with nullFlavor MSK when the Case MRN - GP (mrn_gp_value__v) field has any value or is set to any Reason Omitted (mrn_gp_reason_omitted__v). Otherwise, this element is not transmitted.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number) This element is transmitted with nullFlavor MSK when the Case MRN - Specialist (mrn_specialist_value__v) field has any value or is set to any Reason Omitted (mrn_specialist_reason_omitted__v). Otherwise, this element is not transmitted.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number) This element is transmitted with nullFlavor MSK when the Case MRN - Hospital (mrn_hospital_value__v) field has any value or is set to any Reason Omitted (mrn_hospital_reason_omitted__v). Otherwise, this element is not transmitted.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) This element is transmitted with nullFlavor MSK when the Case MRN - Investigation (mrn_investigation_value__v) field has any value or is set to any Reason Omitted (mrn_investigation_reason_omitted__v). Otherwise, this element is not transmitted.

D.2 Age Information

E2B Data Element Name Populated Value
D.2.1 Date of Birth This element is transmitted with nullFlavor MSK when the Case Date of Birth (dob_idate__v) field has the full date with year, month, and day, or is set to any Reason Omitted (dob_reason_omitted__v). Otherwise, this element is not transmitted.
D.2.2a Age at Time of Onset of Reaction / Event (number) The Age on the Case. In accordance with ICH guidelines, Vault does not transmit this data element if the D.2.1 Date of Birth data element includes a value.
D.2.2b Age at Time of Onset of Reaction / Event (unit) The Age (unit) on the Case. In accordance with ICH guidelines, Vault does not transmit this data element if the D.2.1 Date of Birth data element includes a value.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number) The value in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit) The unit in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter) The value in the Age Group field on the Case. In accordance with ICH guidelines, this element is transmitted only when both the Patient Date of Birth (D.2.1) and Age at Onset (D.2.2) are not transmitted.
D.3 Body Weight (kg) The value in the Weight field on the Case, normalized to the accepted unit.
D.4 Height (cm) The value in the Height field on the Case, normalized to the accepted unit.
D.5 Sex The value in the Sex field on the Case.
D.6 Last Menstrual Period Date The date in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name Populated Value
D.7.1.r.1a MedDRA Version for Medical History Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) The MedDRA LLT coded on the Case Medical History record.
D.7.1.r.2 Start Date The date in the Start Date field on the Case Medical History record.
D.7.1.r.3 Continuing The appropriate value is populated, based on the Continuing field on the Case Medical History record.
D.7.1.r.4 End Date The date in the End Date field on the Case Medical History record.
D.7.1.r.5 Comments Repeated for each Localized Case Medical History record related to the Japanese Localized Case. Mapped from the Comments field (localized_case_medical_history__v.comments__v), to a limit of 2,000 characters.
D.7.1.r.6 Family History The value in the Family History field on the Case Medical History record.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) The text in the Medical History Text field on the Japan Localized Case, to a limit of 10,000 characters. localized_case__v.medical_history_text__v
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

Repeated for each Localized Case Drug History under the Japan Localized Case. Mapped from one of the following sources:

  • Vault first attempts to map this value from the Drug (Reported) field. localized_case_drug_history__v.name_reported__v
  • If the Drug (Reported) field is blank, Vault maps the Drug (Coded) field. localized_case_drug_history__v.product_name__v
D.8.r.2a MPID Version Date/Number The MPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
D.8.r.2b Medicinal Product Identifier (MPID) The value entered in the MPID field on the Case Drug History record.
D.8.r.3a PhPID Version Date/Number The PhPID Version on the Case Drug History record. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
D.8.r.3b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date The date in the Start Date field on the Case Drug History record.
D.8.r.5 End Date The date in the End Date field on the Case Drug History record.
D.8.r.6a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.6b Indication (MedDRA code) The MedDRA LLT coded for the indication on the Case Drug History record.
D.8.r.7a MedDRA Version for Reaction Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.8.r.7b Reaction (MedDRA code) The value in the Reaction MedDRA field on the Case Drug History record.

D.9 In case of Death

E2B Data Element Name Populated Value
D.9.1 Date of Death The date in the Date of Death field on the Case.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.9.2.r.1b Reported Cause(s) of Death (MedDRA code) The MedDRA LLT coded on the Reported Case Cause of Death object.
D.9.2.r.2 Reported Cause(s) of Death (free text) Repeated for each Localized Case Cause of Death under the Japan Localized Case. Mapped from the text entered in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v
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) Repeated for each Autopsy-Determined Localized Case Cause of Death under the Japan Localized Case. Mapped from the value in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v

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

E2B Data Element Name Populated Value
D.10.2.1 Date of Birth of Parent The Date of Birth on the associated Parent Information. For Vault to transmit this value, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number) The Age on the associated Parent Information. In accordance with ICH guidelines, Vault does not transmit this data element if the D.10.2.1 Date of Birth of Parent data element includes a value.
D.10.2.2b Age of Parent (unit) The Age (unit) on the associated Parent Information. In accordance with ICH guidelines, Vault does not transmit this data element if the D.10.2.1 Date of Birth of Parent data element includes a value.
D.10.3 Last Menstrual Period Date of Parent The date in the Last Menstrual field on the associated Parent Information.
D.10.4 Body Weight (kg) of Parent The value in the Weight field on the associated Parent Information.
D.10.5 Height (cm) of Parent The value in the Height (normalized) field on the associated Parent Information.
D.10.6 Sex of Parent The value in the Sex field on the associated Parent Information.
D.10.7.1.r.1a MedDRA Version for Medical History Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code) The MedDRA LLT coded on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.2 Start Date The date in the Start Date field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.3 Continuing The value in the Continuing field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.4 End Date The date in the End Date field on the Case Medical History record on the associated Parent Information.
D.10.7.1.r.5 Comments Repeated for each Localized Case Medical History from the Localized Case for the associated Parent Information. Mapped from the Comments field, to a limit of 2,000 characters. localized_case_medical_history__v.comments__v
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent The text in the Medical History Text field, to a limit of 10,000 characters, from the Localized Case for the associated Parent Information.

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 Repeated for each Localized Case Drug History under a Parent Information related to the Japan Localized Case. Mapped from the value entered in the Name Reported field. localized_case_drug_history__v.name_reported__v
D.10.8.r.2a MPID Version Date/Number The MPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
D.10.8.r.2b Medicinal Product Identifier (MPID) The value in the MPID field on the Case Drug History record on the associated Parent Information.
D.10.8.r.3a PhPID Version Date/Number The PhPID Version on the Case Drug History record on the associated Parent Information. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Drug History record on the associated Parent Information.
D.10.8.r.4 Start Date The date in the Start Date field on the Case Drug History record on the associated Parent Information.
D.10.8.r.5 End Date The date in the End Date field on the Case Drug History record on the associated Parent Information.
D.10.8.r.6a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.
D.10.8.r.6b Indication (MedDRA code) The indication MedDRA LLT coded on the Case Drug History record on the associated Parent Information.
D.10.8.r.7a MedDRA Version for Reaction Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.
D.10.8.r.7b Reactions (MedDRA code) Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parent Information.

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 If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) field on the Case Adverse Event. case_adverse_event__v.event_reported__v
E.i.1.1b Reaction / Event as Reported by the Primary Source Language If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) - Language field on the Case Adverse Event. case_adverse_event__v.event_reported_language__v
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation Repeated for each Localized Case Adverse Event under the Japan Localized Case. Mapped from the text in the Event (Reported) field on the Case Adverse Event. localized_case_adverse_event__v.event_reported__v
E.i.2.1a MedDRA Version for Reaction / Event Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
E.i.2.1b Reaction / Event (MedDRA code) The Event (LLT) on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter The value in the Highlighted Term field on the Case Adverse Event.

E.i.3.2 Seriousness Criteria at Event Level

E2B Data Element Name Populated Value
E.i.3.2a Results in Death Set to True when Results in death is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2b Life Threatening Set to True when Life threatening is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2c Caused / Prolonged Hospitalisation Set to True when Caused / prolonged hospitalisation is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2d Disabling / Incapacitating Set to True when Disabling / incapacitating is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2e Congenital Anomaly / Birth Defect Set to True when Congenital anomaly / birth defect is selected in the Seriousness field on the Case Adverse Event.
E.i.3.2f Other Medically Important Condition Set to True when Other medically important condition or Required Intervention to Prevent Permanent Impairment/Damage (Devices) is selected in the Seriousness field on the Case Adverse Event.
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

For PMDA, section F.r is repeated for each Case Test Result, in ascending order by date.
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 Japan Localized Case Test Result. localized_case_test_result__v.name_reported__v
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 Result (Text) on the Japan Localized Case Test Result. In accordance with ICH guidelines, Vault:
  • Allows numeric values only and does not map values with non-numeric characters.
  • Does not populate this data element if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided.
localized_case_test_result__v.result_text__v
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 Japan Localized Case Test Result. localized_case_test_result__v.comments__v
F.r.7 More Information Available The value in the More Information Available field on the Case Test Result.

G.k Drug(s) Information

Vault transmits section G.k for all Local Reporting Details / Product Joins under the Local Reporting Details associated with the Transmission, ordered by Rank.

If some Local Reporting Details / Product Joins do not have a Rank assigned, Vault transmits Local Reporting Details / Product Joins in the following order:

  1. Case Product Registrations with a Drug Role of "Suspect"
  2. Company Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
  3. External Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
  4. Case Product Registrations with a Drug Role of "Interacting"
  5. Case Product Registrations with a Drug Role of "Concomitant"
  6. Case Product Registrations without a Drug Role
  7. Company Product-type Case Products that do not have a Case Product Registration in Japan
  8. External Product-type Case Products that do not have a Case Product Registration in Japan

When multiple Local Reporting Details / Product Joins have the same or no Rank and the associated Products have the same Drug Role, Vault exports them in order of First Administration Date, starting with the earliest date. If the First Administration Date is blank, Products are exported in order of Creation Date.

Following the above transmissions, Vault also transmits section G.k for all Case Products that are not associated with a Local Reporting Details / Product Join in the following order:

  1. Case Products with a Drug Role of "Suspect"
  2. Case Products with a Drug Role of "Interacting"
  3. Case Products with any other Drug Role
E2B Data Element Name Populated Value
G.k.1 Characterisation of Drug Role The Drug Role on the Case Product.
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.

Your Admin can configure your Vault to exclude units of measurement that the PMDA does not accept. If configured and the G.k.5b Cumulative Dose to First Reaction (unit) data element is excluded, Vault also excludes this data element for that unit.
G.k.5b Cumulative Dose to First Reaction (unit)

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

Your Admin can configure your Vault to exclude or replace units of measurement that the PMDA does not accept. If set to exclude, when Vault excludes this data element, it also excludes the related G.k.5a Cumulative Dose to First Reaction (number) data element. If set to replace, Vault exports {DF} to this data element.
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 Localized Case Product record.

localized_case_product__v.additional_information_on_text__v

When the TIKEN checkbox is selected on the Localized Case Local Reporting Details record, Vault prepends "TIKEN" to this data element for the primary Case Product Registration.

Any text that exceeds the 2000-character limit for this data element is truncated.

G.k.2 Drug Identification

E2B Data Element Name Populated Value
G.k.2.1.1a MPID Version Date / Number The MPID Version on the Case Product. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
G.k.2.1.1b Medicinal Product Identifier (MPID) The value entered in the MPID field on the Case Product record.
G.k.2.1.2a PhPID Version Date/Number The PhPID Version on the Case Product. When the value corresponds to a date, Vault converts it to YYYYMMDD format.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID) The value in the PhPID field on the Case Product record.
G.k.2.2 Medicinal Product Name as Reported by the Primary Source

For products assigned a PMDA Rank, Vault maps data from the Case Product Registration:

  • Vault first attempts to map this value from the Product (Reported) Override field. case_product_registration__v.case_product_reported_override__v
  • If the Product (Reported) Override is blank, Vault attempts to map this value from the Local Product Code. case_product_registration__v.case_local_product_code__v
  • If the Local Product Code is blank, Vault then attempts to map the Clinical Compound Number. case_product_registration__v.clinical_compound_number__v
  • If the Clinical Compound Number is also blank Vault maps the Name. case_product_registration__v.name__v

For Company and External Products without a PMDA Rank, Vault maps data from the Localized Case Product:

  • Vault first attempts to map this value from the Local MPID. localized_case_product__v.local_mpid__v
  • If the Local MPID is blank, Vault then attempts to map the Product Name. localized_case_product__v.product_name__v
  • If the Local MPID is also blank Vault maps the Product (Reported). localized_case_product__v.product_reported__v

When required, Vault truncates text to meet the 250-character limit for this data element. Vault first truncates the list of substances that appear within parentheses. If the remaining text is too long, Vault truncates the text to the first 250 characters.

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

For each Case Product Substance that is a child of a Case Product transmitted in section G.k, if the Japan Product Code Type of the Case Product is J-Drug Code, Vault populates this data element as follows:

  • For Company Products, Vault maps the first seven (7) characters of the Local Product Code on the Case Product Registration.
  • For External Products, Vault maps the first seven (7) characters of the Local MPID on the Localized Case Product.

If a Case Product includes multiple Substances, Vault exports a code as described above for only the first Substance on the Product record. If a Case Product is blinded, Vault exports a code as described for the earliest created Substance on the Product record.

If Case Products do not have a Japan Product Code Type of J-Drug Code, for each Case Product Substance that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Substance, and then maps the substance name using the following logic:

  • Vault first attempts to map the Local Product Code field value.
  • If the Local Product Code is blank, Vault then attempts to map the Name (Reported) field value.
  • If the Name (Reported) is also blank, then Vault maps the Name (Reported) field value on the Case Product Substance from the global Case.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number

The TermID Version on the Case Product Substance. When the value corresponds to a date, Vault converts it to YYYYMMDD format.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.
G.k.2.3.r.2b Substance / Specified Substance TermID

The value in the TermID field on the Case Product Substance.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.
G.k.2.3.r.3a Strength (number)

The value in the Strength (Number) field on the Case Product Substance.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.

Your Admin can configure your Vault to exclude units of measurement that the PMDA does not accept. If configured and the G.k.2.3.r.3b Strength (unit) data element is excluded, Vault also excludes this data element for that unit.
G.k.2.3.r.3b Strength (unit)

The unit in the Strength (Unit) field on the Case Product Substance.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.

Your Admin can configure your Vault to exclude or replace units of measurement that the PMDA does not accept. If set to exclude, when Vault excludes this data element, it also excludes the related G.k.2.3.r.3a Strength (number) data element. If set to replace, Vault exports {DF} to this data element.

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

E2B Data Element Name Populated Value
G.k.3.1 Authorisation / Application Number This element is transmitted only for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Number field on the Case Product Registration. case_product_registration__v.registration_number__v
G.k.3.2 Country of Authorisation / Application This element is transmitted only for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the 2-letter country code for the country selected in the Registration Country on the Case Product Registration. case_product_registration__v.registration_country__vr.abbreviation_2__v
G.k.3.3 Name of Holder / Applicant This element is transmitted only for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Holder/Applicant on the Case Product Registration. case_product_registration__v.registration_mah__v

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.

Your Admin can configure your Vault to exclude units of measurement that the PMDA does not accept. If configured and the G.k.4.r.1b Dose (unit) data element is excluded, Vault also excludes this data element for that unit.
G.k.4.r.1b Dose (unit)

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

Your Admin can configure your Vault to exclude or replace units of measurement that the PMDA does not accept. If set to exclude, when Vault excludes this data element, it also excludes the related G.k.4.r.1a Dose (number) data element. If set to replace, Vault exports {DF} to this data element.
G.k.4.r.2 Number of Units in the Interval The value in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit The unit in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug The value in the First Admin Date field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration The value in the Last Admin Date field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number) The Duration (number) on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit) The unit in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number The value in the Batch/Lot Number field on the Case Product Dosage.

This element is not transmitted when nullFlavors are selected.
G.k.4.r.8 Dosage Text For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Dosage, and then maps the Dosage Text field. localized_case_product_dosage__v.dose_text__v
G.k.4.r.9.1 Pharmaceutical Dose Form (free text) For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault maps the Japan Localized Dose Form corresponding to the value selected in the Dose Form field.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number The Dose Form TermID Version on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID The Dose Form TermID on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Dosage, and then exports the value from the Patient RoA field.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number The Patient RoA TermID Version on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault maps the E2B code corresponding to the value selected in the Patient RoA field.
G.k.4.r.11.1 Parent Route of Administration (free text) For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Dosage, and then exports the value in the Patient RoA Text field.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number The Parent RoA TermID Version on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID This element is transmitted for parent-child/fetus cases only. For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault maps the E2B code corresponding to the value selected the Parent RoA field.

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 Japan Localized Case Product Indication. localized_case_product_indication__v.name_reported__v
G.k.7.r.2a MedDRA Version for Indication Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
G.k.7.r.2b Indication (MedDRA code) The MedDRA LLT coded on the Case Product Indication.

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

Vault does not export this section for device constituent assessments.

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

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

Vault does not export this section for device constituent assessments.

E2B Data Element Name Populated Value
G.k.9.i.2.r.1 Source of Assessment Vault finds the Japan Localized Controlled Vocabulary corresponding to the Source Type on the Case Assessment, and then maps the record Name. If unavailable, Vault maps a value using the following priority:
  1. The Source (text) on the Japan Localized Case Assessment Result
  2. The Source (text) on the Case Assessment Result
G.k.9.i.2.r.2 Method of Assessment Vault finds the Japan Localized Controlled Vocabulary corresponding to the Method of Assessment on the Case Assessment, and then maps the record Name. If unavailable, Vault maps a value using the following priority:
  1. The Method (text) on the Japan Localized Case Assessment Result
  2. The Method (text) on the Case Assessment Result
G.k.9.i.2.r.3 Result of Assessment Vault finds the record Name of the Assessment Result (Override) controlled vocabulary.

If the Assessment Result (Override) is not available, Vault finds the Japan Localized Controlled Vocabulary corresponding to the Assessment Result on the Case Assessment, and then maps the record Name. If unavailable, Vault maps a value using the following priority:

  1. The Result (text) on the Japan Localized Case Assessment Result
  2. The Result (text) on the Case Assessment Result

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 Japan Localized Case, to a limit of 100,000 characters. localized_case__v.narrative_document__v
H.2 Reporter's Comments The Reporter's Comments on the Japan Localized Case, to a limit of 20,000 characters.
H.4 Sender's Comments

Vault selects the Case Comment that matches the Local Reporting Details of the Transmission if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Company Comments (companys_comments_v)
  • The Case Comment has Local Reporting Details specified

If there is no match but there is a Comment with no Local Reporting Details specified, Vault selects that Comment. The H.4 Sender's Comments field is then mapped to the Comments Text of the selected Case Comment.

localized_case_comment__v.comments_text__v

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.

Section J

E2B Data Element Name Populated Value
J2.1a PMDA Reporting Category The E2B code corresponding to the PMDA Reporting Category of the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v.
pmda_reporting_category__v.controlled_vocabulary__v.e2b_code__v
J2.1b PMDA Identification Number The value from the Destination Case ID field from the Local Reporting Details for the Transmission. Populate this value for follow-up reports only. transmission__v.local_reporting_details__v.destination_case_id__v
J2.2.1 Day 0 of Reporting Timeframe The date from the Local Awareness Date on the Japan Localized Case, in the format YYYYMMDD. localized_case__v.local_awareness_date__v
J2.2.2 Comments on Initial Date for Reporting

This field is mapped from the Comments Text field if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Receipt Date Comments (receipt_date_comments__v)
  • The Local Reporting Details matches those of the Transmission

Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment's Label matches the Receipt Date Comments.

localized_case_comment__v.comments_text__v
J2.3 Flag for Immediate Report If the Immediate Report Type field is set to System (E2B) (system_e2b__v) on the Local Reporting Details related to the Transmission, this element is transmitted with 1. transmission__v.local_reporting_details__v.immediate_report_type__v
J2.4.k License Category of New Drug Repeated with the E2B code for the Registration Type on each Case Product Registration corresponding to products transmitted in the G.k section for Company Products. case_product_registration__v.registration_type_cv__v.e2b_code__v
J2.5.k Classification of OTC drugs Repeated with the E2B code for the OTC Drug Classification on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_classification__v.e2b_code__v
J2.6.k Obtaining channels for OTC drugs Repeated with the E2B code or nullFlavor for the OTC Drug Channel on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_channel__v.e2b_code__v
J2.7.1 Completion flag The E2B code for the Completeness on the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v.completeness__v.e2b_code__v
J2.7.2 Comments on Incompletion

This field is mapped from the Comments Text field if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Comments on Completeness (comments_on_completeness_v)
  • The Local Reporting Details matches those of the Transmission

Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment's Label matches the Comments on Completeness.

localized_case_comment__v.comments_text__v
J2.8.1 Downgrade Report If the Downgraded field is set to Yes on this Transmission, this element is transmitted with 1. transmission__v.downgraded__v
J2.8.2 Reason for Downgrading Report

When J2.8.1 is transmitted with 1, this field is mapped from the Comments Text field if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Downgrade Reason (downgrade_reason__v)
  • The Local Reporting Details matches those of the Transmission
localized_case_comment__v.comments_text__v
J2.9 Retrospective analysis of infections If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Retrospective analysis of infections (retrospective_analysis_of_infections__v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.10 Action to be taken If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Action to be Taken (future_actions_v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.11 Other references If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Other References (other_references__v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.12 Clinical Compound Number (CCN) For investigational products only.

When reporting Study Cases for Clinical Trial Studies registered in Japan, Vault maps this value from the Clinical Compound Number field on the Japanese Study Registration.

(Study Registration).clinical_compound_number__v WHERE
(Study Registration).study__v = (Case).(Study) and
(Study Registration).country__v = "Japan"

If the Study is not conducted in Japan and Japanese Study Registration information doesn't exist, this field is populated from the Clinical Compound Number of the Primary Case Product Registration of the Local Reporting Details related to the Transmission.

transmission__v.local_reporting_details__v.
primary_case_product_registration_v.clinical_compound_number__v
J2.14.i Expectedness

This is mapped from the value in the Expected field on each Localized Case Assessment related to the primary PMDA product under the Japan Localized Case:

  • If Yes, 2 is transmitted
  • If No, 1 is transmitted
  • Otherwise, this element is not transmitted

This element is repeated and placed under the appropriate E.i section, based on product and adverse event combination.

If there are multiple products assigned a PMDA Rank and transmitted in section G.k, this element is only transmitted if the primary (Rank 1) PMDA product is the only suspect product (Drug Role = Suspect).

Vault does not export this field for device constituent assessments.

localized_case_assessment__v.expected__v
J2.15.r Country of publication

For each Localized Case Document exported to the C.4.r.1 Literature Reference(s) data element, Vault maps the 2-letter country code for the Publication Country on the Localized Case Document record.

If Publication Country is blank on the Localized Case Document record, Vault maps the country code for the Publication Country on each document attached to the Case with the document type of Case > Source > Literature.

publication_country__v.abbreviation_2__v
J2.16 Overview of the report If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Report Overview (report_overview__v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.17.r Classification of trial/research For each document identified in J2.15.r, Vault maps the E2B code for the Literature Classification on the Localized Case Document record. If Literature Classification is blank on the Localized Case Document record, Vault maps the E2B code for the Literature Classification on each document. literature_classification__v.e2b_code__v

Section J2.13.r

This section is populated only when element J2.12 is transmitted.

This section is repeated for each Study with a Japan Study Registration that has the same Clinical Compound Number as the CCN transmitted in J2.12. For each matching Study, Vault maps elements J2.13.r.1 to J2.13.r.4 using the corresponding Japan Localized Study.

E2B Data Element Name Populated Value
J2.13.r.1 Number of CTN The value from the Number of Clinical Trial Notifications field on the Japan Localized Study. localized_study__v.number_of_clinical_trial_notifications__v
J2.13.r.2 Study indications The value from the Target Disease field on the Japan Localized Study. localized_study__v.target_disease__v
J2.13.r.3 Development phase The E2B code corresponding to the value from the Development Phase field on the global Study related to the Japan Localized Study. localized_study__v.study__v.development_phase__v.e2b_code__v
J2.13.r.4 Existence of subjects The value from the Existence of Subjects field on the Japan Localized Study:
  • If Yes, true is transmitted
  • If No, false is transmitted
  • Otherwise, this element is not transmitted
localized_study__v.existence_of_subjects__v

Section J2.18

Vault Safety uses the Receiver Person from the Transmission Profile to map to elements J2.18.2 to J2.18.4.

E2B Data Element Name Populated Value
J2.18.1 Recipient organization name Mapped using the Transmission for the Japan Localized Case. Vault finds the Japan Localized Organization corresponding to the Destination on the Transmission Profile used for the Transmission. From the Japan Localized Organization, Vault maps the Official Name. localized_organization__v.official_name__v
J2.18.2 Recipient title The Title field on the Receiver Person of the Transmission Profile. person__sys.title__v
J2.18.3 Recipient's family name The Last Name field on the Receiver Person of the Transmission Profile. If "Last Name" is selected in the exclude_from_receiver_block__v field on the associated Receiver Person, this element is omitted. person__sys.last_name__sys
J2.18.4 Recipient's given name The First Name field on the Receiver Person of the Transmission Profile. If "First Name" is selected in the exclude_from_receiver_block__v field on the associated Receiver Person, this element is omitted. person__sys.first_name__sys

PMDA E2B(R3) Mapping - PMDA Regional Mappings

N.1 ICH ICSR Transmission Identification (batch wrapper)

E2B Data Element Name Populated Value
N.1.5 Date of Batch Transmission The value in the Transmission Date field on the ICSR Transmission. Otherwise, the date and time when the report was generated or transmitted. The time is converted to Japan Standard Time (JST) and transmitted in the format CCYYMMDDhhmmss+0900.

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

E2B Data Element Name Populated Value
N.2.r.1 Message Identifier

For PMDA, Vault generates this value during E2B generation using the following fields:

(case_version__v.reporter_country__v.abbreviation_2__v)
(transmission_profile__v.origin_id__v)
(local_reporting_details__v.report_uid__v)

For example: JP-VertBio-000001AB

PMDA requires that when multiple ICSRs are submitted from a single Case, N.2.r.1 and C.1.1 must be different for each ICSR.

To achieve this, Vault Safety adds logic to append suffix (AA-ZZ) to the existing UID generation logic to make it unique per submission. The generated UID is stored in the Report UID field of the Local Reporting Details (local_reporting_details__v.report_uid__v) record.
N.2.r.4 Date of Message Creation The exact date and time when the report was generated, in the format CCYYMMDDhhmmss+0900. The time is converted to Japan Standard Time (JST).

C.1 Identification of the Case Safety Report

E2B Data Element Name Populated Value
C.1.1 Sender's (case) Safety Report Unique Identifier

For PMDA, Vault generates this value during E2B generation using the following fields:

(case_version__v.reporter_country__v.abbreviation_2__v)
(transmission_profile__v.origin_id__v)
(local_reporting_details__v.report_uid_v)

For example: JP-VertBio-000001AB

See N.2.r.1 for unique report UID generation.
C.1.2 Date of Creation The exact date and time when the report was generated, in the format CCYYMMDDhhmmss+0900. The time is converted to Japan Standard Time (JST).
C.1.4 Date Report Was First Received from Source
  • For initial Cases, the date in the Local Initial Receipt Date field on the Localized Case. If blank, the date in the Receipt Date field on the Global Case is exported.
  • For Follow-Up Cases, the date in the Local Initial Receipt Date field on the Localized Case. If blank, the date in the Initial Receipt Date field on the Global Case is exported.

The time is converted to Japan Standard Time (JST).
C.1.5 Date of Most Recent Information for This Report The date in the Local New Info Date field on the Localized Case. If blank, the date in the New Info Date field from the Global Case is exported. The time is converted to Japan Standard Time (JST).

C.1.6 Additional Available Documents Held by Sender

E2B Data Element Name Populated Value
C.1.6.1.r.1 Documents Held by Sender For documents with the Case > Source > Attachment document type, Vault attempts to populate the Attachment Description from the Localized Case Document that is linked to the document, to a limit of 2,000 characters. If unavailable, Vault populates the Description from the global Case Document.
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 domestic 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.1.9.1.r.1 Source(s) of the Case Identifier Repeated for the value in the Source field on each Localized Case Identifier object under the Japanese Localized Case.

This element is transmitted only when the Case Identifier Type (type__v) is set to Re-Transmittable or is blank.

localized_case_identifier__v.source__v

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

E2B Data Element Name Populated Value
C.2.r.3 Reporter's Country Code The ISO code in the Country field on the primary Reporter-type Case Contact. This field is transmitted only if C.2.r.5 is set to 1 (Primary Source) for the corresponding Reporter-type Case Contact.

C.3 Information on Sender of Case Safety Report

E2B Data Element Name Populated Value
C.3.2 Sender Organization The Organization in the Origin field on the PMDA Transmission Profile. transmission_profile__v.origin_transmission_id__v

C.4.r Literature Reference(s)

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

For Case attachments with the document type Case > Source > Literature, Literature > Literature Article > Summary and Literature > Literature Article > Full-text, Vault retrieves the corresponding Japan Localized Case Document and populates this element with the value in the Reference field to a limit of 500 characters.

For Case attachments with the document type Literature > Literature Article and for each document identified in the J2.15.r Country of Publication data element, Vault maps a value using the following priority order:

  • The Reference field value from the Localized Case Document
  • The value from the C.4.r.1 data element on the E2B file for the global Case
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 domestic Cases or Localized Cases with previous Transmissions that included the literature article to the same reporting destination.

C.5 Study Identification

E2B Data Element Name Populated Value
C.5.2 Study Name

The value in the Study Name field on the Localized Study for Japan associated with the Study on the global Case.

If there is no Localized Study for Japan, Vault exports the value in the Study Name field on the associated global 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) This element is transmitted with nullFlavor MSK when the Case MRN - GP (mrn_gp_value__v) field has any value or is set to any Reason Omitted (mrn_gp_reason_omitted__v). Otherwise, this element is not transmitted.
D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number) This element is transmitted with nullFlavor MSK when the Case MRN - Specialist (mrn_specialist_value__v) field has any value or is set to any Reason Omitted (mrn_specialist_reason_omitted__v). Otherwise, this element is not transmitted.
D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number) This element is transmitted with nullFlavor MSK when the Case MRN - Hospital (mrn_hospital_value__v) field has any value or is set to any Reason Omitted (mrn_hospital_reason_omitted__v). Otherwise, this element is not transmitted.
D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) This element is transmitted with nullFlavor MSK when the Case MRN - Investigation (mrn_investigation_value__v) field has any value or is set to any Reason Omitted (mrn_investigation_reason_omitted__v). Otherwise, this element is not transmitted.

D.2 Age Information

E2B Data Element Name Populated Value
D.2.1 Date of Birth This element is transmitted with nullFlavor MSK when the Case Date of Birth (dob_idate__v) field has the full date with year, month, and day, or is set to any Reason Omitted (dob_reason_omitted__v). Otherwise, this element is not transmitted.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name Populated Value
D.7.1.r.5 Comments Repeated for each Localized Case Medical History record related to the Japanese Localized Case. Mapped from the Comments field (localized_case_medical_history__v.comments__v), to a limit of 2,000 characters.
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 Japan Localized Case, to a limit of 10,000 characters. localized_case__v.medical_history_text__v

D.8.r Relevant Past Drug History

E2B Data Element Name Populated Value
D.8.r.1 Name of Drug as Reported

Repeated for each Localized Case Drug History under the Japan Localized Case. Mapped from one of the following sources:

  • Vault first attempts to map this value from the Drug (Reported) field. localized_case_drug_history__v.name_reported__v
  • If the Drug (Reported) field is blank, Vault maps the Drug (Coded) field. localized_case_drug_history__v.product_name__v

D.9 In case of Death

E2B Data Element Name Populated Value
D.9.2.r.2 Reported Cause(s) of Death (free text) Repeated for each Localized Case Cause of Death under the Japan Localized Case. Mapped from the text entered in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v
D.9.4.r.2 Autopsy-determined Cause(s) of Death (free text) Repeated for each Autopsy-Determined Localized Case Cause of Death under the Japan Localized Case. Mapped from the value in the Name (Reported) field. localized_case_cause_of_death__v.name_reported__v

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

E2B Data Element Name Populated Value
D.10.7.1.r.5 Comments Repeated for each Localized Case Medical History from the Localized Case for the associated Parent Information. Mapped from the Comments field, to a limit of 2,000 characters. localized_case_medical_history__v.comments__v
D.10.7.2 Text for Relevant Medical History and Concurrent Conditions of Parent The text in the Medical History Text field, to a limit of 10,000 characters, from the Localized Case for the associated Parent Information.

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 Repeated for each Localized Case Drug History under a Parent Information related to the Japan Localized Case. Mapped from the value entered in the Name Reported field. localized_case_drug_history__v.name_reported__v

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 If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) field on the Case Adverse Event. case_adverse_event__v.event_reported__v
E.i.1.1b Reaction / Event as Reported by the Primary Source Language If the Event (Reported) - Language field is set to either English or Japanese, this value is mapped from the text entered in the Event (Reported) - Language field on the Case Adverse Event. case_adverse_event__v.event_reported_language__v
E.i.1.2 Reaction / Event as Reported by the Primary Source for Translation Repeated for each Localized Case Adverse Event under the Japan Localized Case. Mapped from the text in the Event (Reported) field on the Case Adverse Event. localized_case_adverse_event__v.event_reported__v

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

For PMDA, section F.r is repeated for each Case Test Result, in ascending order by date.
E2B Data Element Name Populated Value
F.r.2.1 Test Name (free text) The value in the Test Name (Reported) field on the Japan Localized Case Test Result. localized_case_test_result__v.name_reported__v
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.3.4 Result Unstructured Data (free text) The Result (Text) on the Japan Localized Case Test Result. In accordance with ICH guidelines, Vault:
  • Allows numeric values only and does not map values with non-numeric characters.
  • Does not populate this data element if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided.
localized_case_test_result__v.result_text__v
F.r.6 Comments (free text) The value in the Comments field on the Japan Localized Case Test Result. localized_case_test_result__v.comments__v

G.k Drug(s) Information

Vault transmits section G.k for all Local Reporting Details / Product Joins under the Local Reporting Details associated with the Transmission, ordered by Rank.

If some Local Reporting Details / Product Joins do not have a Rank assigned, Vault transmits Local Reporting Details / Product Joins in the following order:

  1. Case Product Registrations with a Drug Role of "Suspect"
  2. Company Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
  3. External Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
  4. Case Product Registrations with a Drug Role of "Interacting"
  5. Case Product Registrations with a Drug Role of "Concomitant"
  6. Case Product Registrations without a Drug Role
  7. Company Product-type Case Products that do not have a Case Product Registration in Japan
  8. External Product-type Case Products that do not have a Case Product Registration in Japan

When multiple Local Reporting Details / Product Joins have the same or no Rank and the associated Products have the same Drug Role, Vault exports them in order of First Administration Date, starting with the earliest date. If the First Administration Date is blank, Products are exported in order of Creation Date.

Following the above transmissions, Vault also transmits section G.k for all Case Products that are not associated with a Local Reporting Details / Product Join in the following order:

  1. Case Products with a Drug Role of "Suspect"
  2. Case Products with a Drug Role of "Interacting"
  3. Case Products with any other Drug Role
E2B Data Element Name Populated Value
G.k.5a Cumulative Dose to First Reaction (number)

The value in the Cumulative Dose field on the Case Product record.

Your Admin can configure your Vault to exclude units of measurement that the PMDA does not accept. If configured and the G.k.5b Cumulative Dose to First Reaction (unit) data element is excluded, Vault also excludes this data element for that unit.
G.k.5b Cumulative Dose to First Reaction (unit)

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

Your Admin can configure your Vault to exclude or replace units of measurement that the PMDA does not accept. If set to exclude, when Vault excludes this data element, it also excludes the related G.k.5a Cumulative Dose to First Reaction (number) data element. If set to replace, Vault exports {DF} to this data element.
G.k.11 Additional Information on Drug (free text)

The value in the Additional Information (text) field on the Localized Case Product record.

localized_case_product__v.additional_information_on_text__v

When the TIKEN checkbox is selected on the Localized Case Local Reporting Details record, Vault prepends "TIKEN" to this data element for the primary Case Product Registration.

Any text that exceeds the 2000-character limit for this data element is truncated.

G.k.2 Drug Identification

E2B Data Element Name Populated Value
G.k.2.2 Medicinal Product Name as Reported by the Primary Source

For products assigned a PMDA Rank, Vault maps data from the Case Product Registration:

  • Vault first attempts to map this value from the Product (Reported) Override field. case_product_registration__v.case_product_reported_override__v
  • If the Product (Reported) Override is blank, Vault attempts to map this value from the Local Product Code. case_product_registration__v.case_local_product_code__v
  • If the Local Product Code is blank, Vault then attempts to map the Clinical Compound Number. case_product_registration__v.clinical_compound_number__v
  • If the Clinical Compound Number is also blank Vault maps the Name. case_product_registration__v.name__v

For Company and External Products without a PMDA Rank, Vault maps data from the Localized Case Product:

  • Vault first attempts to map this value from the Local MPID. localized_case_product__v.local_mpid__v
  • If the Local MPID is blank, Vault then attempts to map the Product Name. localized_case_product__v.product_name__v
  • If the Local MPID is also blank Vault maps the Product (Reported). localized_case_product__v.product_reported__v

When required, Vault truncates text to meet the 250-character limit for this data element. Vault first truncates the list of substances that appear within parentheses. If the remaining text is too long, Vault truncates the text to the first 250 characters.

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

For each Case Product Substance that is a child of a Case Product transmitted in section G.k, if the Japan Product Code Type of the Case Product is J-Drug Code, Vault populates this data element as follows:

  • For Company Products, Vault maps the first seven (7) characters of the Local Product Code on the Case Product Registration.
  • For External Products, Vault maps the first seven (7) characters of the Local MPID on the Localized Case Product.

If a Case Product includes multiple Substances, Vault exports a code as described above for only the first Substance on the Product record. If a Case Product is blinded, Vault exports a code as described for the earliest created Substance on the Product record.

If Case Products do not have a Japan Product Code Type of J-Drug Code, for each Case Product Substance that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Substance, and then maps the substance name using the following logic:

  • Vault first attempts to map the Local Product Code field value.
  • If the Local Product Code is blank, Vault then attempts to map the Name (Reported) field value.
  • If the Name (Reported) is also blank, then Vault maps the Name (Reported) field value on the Case Product Substance from the global Case.
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number

The TermID Version on the Case Product Substance. When the value corresponds to a date, Vault converts it to YYYYMMDD format.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.
G.k.2.3.r.2b Substance / Specified Substance TermID

The value in the TermID field on the Case Product Substance.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.
G.k.2.3.r.3a Strength (number)

The value in the Strength (Number) field on the Case Product Substance.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.

Your Admin can configure your Vault to exclude units of measurement that the PMDA does not accept. If configured and the G.k.2.3.r.3b Strength (unit) data element is excluded, Vault also excludes this data element for that unit.
G.k.2.3.r.3b Strength (unit)

The unit in the Strength (Unit) field on the Case Product Substance.

When the G.k.2.3.r.1 Substance / Specified Substance Name data element includes a Case Product with a Japan Product Code Type of J-Drug Code, Vault does not export this data element.

Your Admin can configure your Vault to exclude or replace units of measurement that the PMDA does not accept. If set to exclude, when Vault excludes this data element, it also excludes the related G.k.2.3.r.3a Strength (number) data element. If set to replace, Vault exports {DF} to this data element.

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

E2B Data Element Name Populated Value
G.k.3.1 Authorisation / Application Number This element is transmitted only for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Number field on the Case Product Registration. case_product_registration__v.registration_number__v
G.k.3.2 Country of Authorisation / Application This element is transmitted only for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the 2-letter country code for the country selected in the Registration Country on the Case Product Registration. case_product_registration__v.registration_country__vr.abbreviation_2__v
G.k.3.3 Name of Holder / Applicant This element is transmitted only for products assigned a PMDA Rank on the Case Product Registration. This value is mapped from the Registration Holder/Applicant on the Case Product Registration. case_product_registration__v.registration_mah__v

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.

Your Admin can configure your Vault to exclude units of measurement that the PMDA does not accept. If configured and the G.k.4.r.1b Dose (unit) data element is excluded, Vault also excludes this data element for that unit.
G.k.4.r.1b Dose (unit)

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

Your Admin can configure your Vault to exclude or replace units of measurement that the PMDA does not accept. If set to exclude, when Vault excludes this data element, it also excludes the related G.k.4.r.1a Dose (number) data element. If set to replace, Vault exports {DF} to this data element.
G.k.4.r.7 Batch / Lot Number The value in the Batch/Lot Number field on the Case Product Dosage.

This element is not transmitted when nullFlavors are selected.
G.k.4.r.8 Dosage Text For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Dosage, and then maps the Dosage Text field. localized_case_product_dosage__v.dose_text__v
G.k.4.r.9.1 Pharmaceutical Dose Form (free text) For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault maps the Japan Localized Dose Form corresponding to the value selected in the Dose Form field.
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number The Dose Form TermID Version on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID The Dose Form TermID on the Case Product Dosage.
G.k.4.r.10.1 Route of Administration For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Dosage, and then exports the value from the Patient RoA field.
G.k.4.r.10.2a Route of Administration TermID Version Date / Number The Patient RoA TermID Version on the Case Product Dosage.
G.k.4.r.10.2b Route of Administration TermID For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault maps the E2B code corresponding to the value selected in the Patient RoA field.
G.k.4.r.11.1 Parent Route of Administration (free text) For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault finds the corresponding Japan Localized Case Product Dosage, and then exports the value in the Patient RoA Text field.
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number The Parent RoA TermID Version on the Case Product Dosage.
G.k.4.r.11.2b Parent Route of Administration TermID This element is transmitted for parent-child/fetus cases only. For each Case Product Dosage that is a child of a Case Product transmitted in section G.k, Vault maps the E2B code corresponding to the value selected the Parent RoA field.

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 Japan Localized Case Product Indication. localized_case_product_indication__v.name_reported__v

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

E2B Data Element Name Populated Value
G.k.9.i.2.r.1 Source of Assessment Vault finds the Japan Localized Controlled Vocabulary corresponding to the Source Type on the Case Assessment, and then maps the record Name. If unavailable, Vault maps a value using the following priority:
  1. The Source (text) on the Japan Localized Case Assessment Result
  2. The Source (text) on the Case Assessment Result
G.k.9.i.2.r.2 Method of Assessment Vault finds the Japan Localized Controlled Vocabulary corresponding to the Method of Assessment on the Case Assessment, and then maps the record Name. If unavailable, Vault maps a value using the following priority:
  1. The Method (text) on the Japan Localized Case Assessment Result
  2. The Method (text) on the Case Assessment Result
G.k.9.i.2.r.3 Result of Assessment Vault finds the record Name of the Assessment Result (Override) controlled vocabulary.

If the Assessment Result (Override) is not available, Vault finds the Japan Localized Controlled Vocabulary corresponding to the Assessment Result on the Case Assessment, and then maps the record Name. If unavailable, Vault maps a value using the following priority:

  1. The Result (text) on the Japan Localized Case Assessment Result
  2. The Result (text) on the Case Assessment Result

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 Japan Localized Case, to a limit of 100,000 characters. localized_case__v.narrative_document__v
H.2 Reporter's Comments The Reporter's Comments on the Japan Localized Case, to a limit of 20,000 characters.
H.4 Sender's Comments

Vault selects the Case Comment that matches the Local Reporting Details of the Transmission if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Company Comments (companys_comments_v)
  • The Case Comment has Local Reporting Details specified

If there is no match but there is a Comment with no Local Reporting Details specified, Vault selects that Comment. The H.4 Sender's Comments field is then mapped to the Comments Text of the selected Case Comment.

localized_case_comment__v.comments_text__v

Section J

E2B Data Element Name Populated Value
J2.1a PMDA Reporting Category The E2B code corresponding to the PMDA Reporting Category of the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v.
pmda_reporting_category__v.controlled_vocabulary__v.e2b_code__v
J2.1b PMDA Identification Number The value from the Destination Case ID field from the Local Reporting Details for the Transmission. Populate this value for follow-up reports only. transmission__v.local_reporting_details__v.destination_case_id__v
J2.2.1 Day 0 of Reporting Timeframe The date from the Local Awareness Date on the Japan Localized Case, in the format YYYYMMDD. localized_case__v.local_awareness_date__v
J2.2.2 Comments on Initial Date for Reporting

This field is mapped from the Comments Text field if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Receipt Date Comments (receipt_date_comments__v)
  • The Local Reporting Details matches those of the Transmission

Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment's Label matches the Receipt Date Comments.

localized_case_comment__v.comments_text__v
J2.3 Flag for Immediate Report If the Immediate Report Type field is set to System (E2B) (system_e2b__v) on the Local Reporting Details related to the Transmission, this element is transmitted with 1. transmission__v.local_reporting_details__v.immediate_report_type__v
J2.4.k License Category of New Drug Repeated with the E2B code for the Registration Type on each Case Product Registration corresponding to products transmitted in the G.k section for Company Products. case_product_registration__v.registration_type_cv__v.e2b_code__v
J2.5.k Classification of OTC drugs Repeated with the E2B code for the OTC Drug Classification on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_classification__v.e2b_code__v
J2.6.k Obtaining channels for OTC drugs Repeated with the E2B code or nullFlavor for the OTC Drug Channel on each Case Product Registration corresponding to products transmitted in the G.k section. case_product_registration__v.otc_drug_channel__v.e2b_code__v
J2.7.1 Completion flag The E2B code for the Completeness on the Local Reporting Details related to the Transmission. transmission__v.local_reporting_details__v.completeness__v.e2b_code__v
J2.7.2 Comments on Incompletion

This field is mapped from the Comments Text field if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Comments on Completeness (comments_on_completeness_v)
  • The Local Reporting Details matches those of the Transmission

Otherwise, this field is mapped from the Comments Text field where the Localized Case Comment's Label matches the Comments on Completeness.

localized_case_comment__v.comments_text__v
J2.8.1 Downgrade Report If the Downgraded field is set to Yes on this Transmission, this element is transmitted with 1. transmission__v.downgraded__v
J2.8.2 Reason for Downgrading Report

When J2.8.1 is transmitted with 1, this field is mapped from the Comments Text field if:

  • The Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Downgrade Reason (downgrade_reason__v)
  • The Local Reporting Details matches those of the Transmission
localized_case_comment__v.comments_text__v
J2.9 Retrospective analysis of infections If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Retrospective analysis of infections (retrospective_analysis_of_infections__v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.10 Action to be taken If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Action to be Taken (future_actions_v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.11 Other references If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Other References (other_references__v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.12 Clinical Compound Number (CCN) For investigational products only.

When reporting Study Cases for Clinical Trial Studies registered in Japan, Vault maps this value from the Clinical Compound Number field on the Japanese Study Registration.

(Study Registration).clinical_compound_number__v WHERE
(Study Registration).study__v = (Case).(Study) and
(Study Registration).country__v = "Japan"

If the Study is not conducted in Japan and Japanese Study Registration information doesn't exist, this field is populated from the Clinical Compound Number of the Primary Case Product Registration of the Local Reporting Details related to the Transmission.

transmission__v.local_reporting_details__v.
primary_case_product_registration_v.clinical_compound_number__v
J2.14.i Expectedness

This is mapped from the value in the Expected field on each Localized Case Assessment related to the primary PMDA product under the Japan Localized Case:

  • If Yes, 2 is transmitted
  • If No, 1 is transmitted
  • Otherwise, this element is not transmitted

This element is repeated and placed under the appropriate E.i section, based on product and adverse event combination.

If there are multiple products assigned a PMDA Rank and transmitted in section G.k, this element is only transmitted if the primary (Rank 1) PMDA product is the only suspect product (Drug Role = Suspect).

Vault does not export this field for device constituent assessments.

localized_case_assessment__v.expected__v
J2.15.r Country of publication

For each Localized Case Document exported to the C.4.r.1 Literature Reference(s) data element, Vault maps the 2-letter country code for the Publication Country on the Localized Case Document record.

If Publication Country is blank on the Localized Case Document record, Vault maps the country code for the Publication Country on each document attached to the Case with the document type of Case > Source > Literature.

publication_country__v.abbreviation_2__v
J2.16 Overview of the report If the Japan Localized Case contains a Localized Case Comment where the Comments Label (comments_label__v) field is set to Report Overview (report_overview__v) and the Local Reporting Details matches those of the Transmission, this field is mapped from the Comments Text field. localized_case_comment__v.comments_text__v
J2.17.r Classification of trial/research For each document identified in J2.15.r, Vault maps the E2B code for the Literature Classification on the Localized Case Document record. If Literature Classification is blank on the Localized Case Document record, Vault maps the E2B code for the Literature Classification on each document. literature_classification__v.e2b_code__v

Section J2.13.r

This section is populated only when element J2.12 is transmitted.

This section is repeated for each Study with a Japan Study Registration that has the same Clinical Compound Number as the CCN transmitted in J2.12. For each matching Study, Vault maps elements J2.13.r.1 to J2.13.r.4 using the corresponding Japan Localized Study.

E2B Data Element Name Populated Value
J2.13.r.1 Number of CTN The value from the Number of Clinical Trial Notifications field on the Japan Localized Study. localized_study__v.number_of_clinical_trial_notifications__v
J2.13.r.2 Study indications The value from the Target Disease field on the Japan Localized Study. localized_study__v.target_disease__v
J2.13.r.3 Development phase The E2B code corresponding to the value from the Development Phase field on the global Study related to the Japan Localized Study. localized_study__v.study__v.development_phase__v.e2b_code__v
J2.13.r.4 Existence of subjects The value from the Existence of Subjects field on the Japan Localized Study:
  • If Yes, true is transmitted
  • If No, false is transmitted
  • Otherwise, this element is not transmitted
localized_study__v.existence_of_subjects__v

Section J2.18

Vault Safety uses the Receiver Person from the Transmission Profile to map to elements J2.18.2 to J2.18.4.

E2B Data Element Name Populated Value
J2.18.1 Recipient organization name Mapped using the Transmission for the Japan Localized Case. Vault finds the Japan Localized Organization corresponding to the Destination on the Transmission Profile used for the Transmission. From the Japan Localized Organization, Vault maps the Official Name. localized_organization__v.official_name__v
J2.18.2 Recipient title The Title field on the Receiver Person of the Transmission Profile. person__sys.title__v
J2.18.3 Recipient's family name The Last Name field on the Receiver Person of the Transmission Profile. If "Last Name" is selected in the exclude_from_receiver_block__v field on the associated Receiver Person, this element is omitted. person__sys.last_name__sys
J2.18.4 Recipient's given name The First Name field on the Receiver Person of the Transmission Profile. If "First Name" is selected in the exclude_from_receiver_block__v field on the associated Receiver Person, this element is omitted. person__sys.first_name__sys
[1]: #pmda-e2b-r3-regional