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.

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

Note: Vault Safety automatically validates E2B files. Case and Submission Validation provides more information. In addition, Vault Safety enables you to configure custom Validation Criteria for Case data through the user-friendly Vault Expression Engine. For more information, see Configure Custom Validation Criteria.

PMDA E2B(R3) Mapping

Note: A Japan Localized Case must contain at least one (1) Local Reporting Details record that includes a Case Product Registration assigned PMDA Rank 1 (primary) and a PMDA Transmission record.

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 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 entered in the E2B Message ID field on the Transmission (Submission or Distribution) record.
N.1.3 Batch Sender Identifier	The value entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.4 Batch Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.1.5 Date of Batch Transmission	The value entered in the Transmission Date field on the Transmission (Submission or Distribution) record. 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 Note For Vault to generate this value, all three fields must be populated. If any field is blank, this data element is not exported. 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 entered in the Origin ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.3 Message Receiver Identifier	The value entered in the Destination ID field on the Transmission Profile associated with the Transmission (Submission or Distribution) record.
N.2.r.4 Date of Message Creation	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 Note For Vault to generate this value, all three fields must be populated. If any field is blank, this data element is exported with no value populated. 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	The appropriate value is populated, based on the option selected in the Report Type field on the Case: `1`: Spontaneous `2`: Study `3`: Other `4`: Unknown
C.1.4 Date Report Was First Received from Source	For initial Cases, the date entered 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 entered 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 entered 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 Transmission (Submission or Distribution) record has a value, Vault uses this value. If this field is not specified on the Transmission, Vault looks at the Expedited field on the Case. If the value is Yes, this element is populated with `1` (expedited). Otherwise, this element is populated 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	Vault first finds any file attached to the Case with the document type of Case > Source > Attachment. Then, Vault retrieves the corresponding Japanese Localized Case Document and populates this element with the Attachment Description, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank. `localized_case_document__v.attachment_description__v`
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 or blank, they are encoded. If the Retransmit field is set to No, documents are not encoded.

C.1.8 Worldwide Unique Case Identification

E2B Data Element Name	Populated Value
C.1.8.1 Worldwide Unique Case Identification Number	The value entered in the Worldwide UID field on the Case Number object.
C.1.8.2 First Sender of This Case	The value entered 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 entered 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 entered in the Case Identifier field on the Case Identifier object. This element is transmitted only when the Case Identifier Type (`type__v`) is set to Re-Transmittable or is blank.
C.1.10.r Identification Number of the Report Which Is Linked to This Report	The value entered in the Related Case Identifier field on the Case Relationship object. This value is exported when the Retransmit field on the record is set to Yes.
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 entered 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 populated in the Country field on the primary Reporter-type Case Contact. This field is only transmitted if C.2.r.5 is set to `1` (Primary Source) for the corresponding Reporter-type Case Contact.
C.2.r.4 Qualification	The option selected 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 option selected in the Sender Type field in the Organization record associated with the Sender User on the Transmission (Submission or Distribution) record. If the Sender User is not specified on the Transmission, by default Vault maps the Sender Type from the Organization on the Case.
C.3.2 Sender Organization	The Organization selected 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 entered in the Title field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.3 Sender's Given Name	The value entered in the First Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.4 Sender's Middle Name	The value entered in the Middle Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.3.5 Sender's Family Name	The value entered in the Last Name field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.1 Sender's Street Address	The value entered in the Street field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.2 Sender's City	The value entered in the City field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.3 Sender's State or Province	The value entered in the State / Province field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.4 Sender's Postcode	The value entered in the Zip/Postal Code field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.5 Sender's Country Code	The 2-letter ISO code associated with the country selected in the Country field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.6 Sender's Telephone	The value entered in the Telephone field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.
C.3.4.7 Sender's Fax	The value entered in the Fax field in the Person record associated with the Sender User on the Transmission (Submission or Distribution) record.

C.4.r Literature Reference(s)

E2B Data Element Name Populated Value

C.4.r.1 Literature Reference(s) Vault first finds any Case attachments with the document type of Case > Source > Literature. Then, Vault retrieves the corresponding Japanese Localized Case Document and populates this element with the Reference, to a limit of 500 characters. localized_case_document__v.reference_text__v

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

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.1.r.1 Study Registration Number	The value entered in the Registration Number field on the Case Study Registration object.
C.5.1.r.2 Study Registration Country	The 2-letter ISO code associated with the country selected in the Country field on the Case Study Registration object. For EMA E2B exports, country codes within the jurisdiction of EMA are replaced with EU in the resulting E2B file.
C.5.2 Study Name	The value entered 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 value entered in the Study Number field on the associated Study.
C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed	The option populated in the Study Type field on the Case.

D Patient Characteristics

E2B Data Element Name	Populated Value
D.1 Patient (name or initials)	The value entered 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 nullFlavour `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 nullFlavour `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 nullFlavour `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 nullFlavour `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 nullFlavour `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 value in the Age field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2b Age at Time of Onset of Reaction / Event (unit)	The value in the Age (unit) field on the Case. In accordance with ICH guidelines, this element is not transmitted if the Patient Date of Birth (D.2.1) is transmitted.
D.2.2.1a Gestation Period When Reaction / Event Was Observed in the Foetus (number)	The value in the Gestation field on the Case.
D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit)	The unit in the Gestation (unit) field on the Case.
D.2.3 Patient Age Group (as per reporter)	The option populated in the Age Group field on the Case. In accordance with ICH guidelines, this element is only transmitted when both the Patient Date of Birth (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 option populated in the Sex field on the Case.
D.6 Last Menstrual Period Date	The date in the Last Menstrual field on the Case.

D.7 Relevant Medical History and Concurrent Conditions

E2B Data Element Name	Populated Value
D.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field.
D.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object.
D.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object.
D.7.1.r.3 Continuing	The appropriate value is populated, based on the Continuing field on the Case Medical History object.
D.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object.
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 selected in the Family History field on the Case Medical History object.
D.7.2 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)	The text entered 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 value entered in the MPID Version field on the Case Drug History record.
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 value entered in the PhPID Version field on the Case Drug History record.
D.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History record.
D.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History record.
D.8.r.5 End Date	The value entered 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 entered 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 entered 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 selected 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 entered in the Date of Birth field on the associated Parental-type Case. For this data element to be transmitted, the full date is required with year, month, and day.
D.10.2.2a Age of Parent (number)	The value entered in the Age field on the associated Parental-type Case.
D.10.2.2b Age of Parent (unit)	The unit entered in the Age (unit) field on the associated Parental-type Case.
D.10.3 Last Menstrual Period Date of Parent	The date entered in the Last Menstrual field on the associated Parental-type Case.
D.10.4 Body Weight (kg) of Parent	The value entered in the Weight field on the associated Parental-type Case.
D.10.5 Height (cm) of Parent	The value entered in the Height (normalized) field on the associated Parental-type Case.
D.10.6 Sex of Parent	The value entered in the Sex field on the associated Parent Information Case.
D.10.7.1.r.1a MedDRA Version for Medical History	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.7.1.r.1b Medical History (disease / surgical procedure / etc.) (MedDRA code)	The MedDRA LLT coded on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.2 Start Date	The date entered in the Start Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.3 Continuing	The value selected in the Continuing field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.4 End Date	The date entered in the End Date field on the Case Medical History object on the associated Parental-type Case.
D.10.7.1.r.5 Comments	Repeated for each Localized Case Medical History from the Localized Case for the associated Parental-type Case. 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 entered in the Medical History Text field, to a limit of 10,000 characters, from the Localized Case for the associated Parental-type Case.

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 Parental-type Case 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 value entered in the MPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.2b Medicinal Product Identifier (MPID)	The value entered in the MPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3a PhPID Version Date/Number	The value entered in the PhPID Version field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID)	The value entered in the PhPID field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.4 Start Date	The date entered in the Start Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.5 End Date	The date entered in the End Date field on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.6a MedDRA Version for Indication	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.6b Indication (MedDRA code)	The indication MedDRA LLT coded on the Case Drug History object on the associated Parental-type Case.
D.10.8.r.7a MedDRA Version for Reaction	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.
D.10.8.r.7b Reactions (MedDRA code)	Populated with the active MedDRA dictionary on the Case, taken from the MedDRA Version field on the associated Parental-type Case.

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

E2B Data Element Name	Populated Value
E.i.1.1a Reaction / Event as Reported by the Primary Source in Native Language	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 entered 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 value entered in the Event (MedDRA) field on the Case Adverse Event.
E.i.3.1 Term Highlighted by the Reporter	The value selected 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 entered in the Onset field on the Case Adverse Event.

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

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

E.i.6b Duration of Reaction / Event (unit) The unit entered 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 selected in the Outcome field on the Case Adverse Event.

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

See the following table for the E2B code values and their corresponding E2B(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 entered 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 entered in the Test Date field on the Case Test Result.
F.r.2.1 Test Name (free text)	The information entered 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 selected in the Result (code) field on the Case Test Result.
F.r.3.2 Test Result (value / qualifier)	The values entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.3 Test Result (unit)	The unit selected 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 information entered in the Result (Text) field on the Japan Localized Case Test Result. In accordance with ICH guidelines, Vault adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element. `localized_case_test_result__v.result_text__v`
F.r.4 Normal Low Value	The unit and value entered in the Normal Low Value field on the Case Test Result. If the result does not have a unit, Vault will map any text entered instead.
F.r.5 Normal High Value	The unit and value entered in the Normal High Value field on the Case Test Result. If the result does not have a unit, Vault will map any text entered instead.
F.r.6 Comments (free text)	The information entered 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 entered 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.

Note When Local Reporting Details are not associated with the Transmission or there is no Case Product Registration associated with the Local Reporting Details, the G.k. section will not be exported properly.

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

Case Product Registrations with a Drug Role of "Suspect"
Company Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
External Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
Case Product Registrations with a Drug Role of "Interacting"
Case Product Registrations with a Drug Role of "Concomitant"
Case Product Registrations without a Drug Role
Company Product-type Case Products that do not have a Case Product Registration in Japan
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:

Case Products with a Drug Role of "Suspect"
Case Products with a Drug Role of "Interacting"
Case Products with any other Drug Role

E2B Data Element Name Populated Value

G.k.1 Characterisation of Drug Role The value entered in the Drug Role field on the Case Product record.

G.k.2.4 Identification of the Country Where the Drug Was Obtained The value entered in the Country Obtained field on the Case Product record.

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

G.k.5a Cumulative Dose to First Reaction (number)

The value entered 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 selected 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 entered in the Gestation Exposure field on the Case Product record.

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

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

The value selected 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 selected in the Additional Information field on the Case Product record.

G.k.11 Additional Information on Drug (free text)

The information entered 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 value entered in the MPID Version field on the Case Product record.
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 value entered in the PhPID Version field on the Case Product record.
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID)	The value entered 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 code on the Localized Case Product. If a Case Product includes multiple Substances, Vault exports a Substance code as described above for only the first Substance on the Product record. If a Case Product is blinded, Vault exports a Substance 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 this value from the Local Product Code field. `localized_case_product_substance__v.local_product_code__v` If the Local Product Code is blank, Vault then attempts to map the Name (Reported) field. `localized_case_product_substance__v.name_reported__v` If the Name (Reported) is also blank, then Vault maps the Name (Reported) field on the Case Product Substance from the global Case. `case_product_substance__v.name_reported__v`
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value entered in the TermID Version 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.2b Substance / Specified Substance TermID	The value entered 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 entered 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 selected 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 only transmitted 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 only transmitted 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 only transmitted 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 entered 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 selected 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 entered in the Frequency (number) field on the Case Product Dosage.
G.k.4.r.3 Definition of the Time Interval Unit	The unit selected in the Frequency (unit) field on the Case Product Dosage.
G.k.4.r.4 Date and Time of Start of Drug	The information entered in the First Administration field on the Case Product Dosage.
G.k.4.r.5 Date and Time of Last Administration	The information entered in the Last Administration field on the Case Product Dosage.
G.k.4.r.6a Duration of Drug Administration (number)	The value entered in the Duration (number) field on the Case Product Dosage.
G.k.4.r.6b Duration of Drug Administration (unit)	The unit selected in the Duration (unit) field on the Case Product Dosage.
G.k.4.r.7 Batch / Lot Number	The information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours 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. `case_product_dosage__v.dose_form__v.localized_dose_form__v.e2b_code__v`
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	The information entered in the Dose Form TermID Version field on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	The information entered in the Dose Form TermID field 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 maps the value from the Patient RoA field. `localized_case_product_dosage__v.patient_adminroute_text__v`
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	The information entered in the Patient RoA TermID Version field 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. `case_product_dosage__v.patient_adminroute__vr.e2b_code__v`
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 maps the Patient RoA Text field. `localized_case_product_dosage__v.parent_adminroute_text__v`
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	The information entered in the Parent RoA TermID Version field 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. `case_product_dosage__v.parent_adminroute__vr.e2b_code__v`

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

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

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

E2B Data Element Name Populated Value

G.k.9.i.2.r.1 Source of Assessment

E2B Data Element Name	Populated Value
G.k.9.i.2.r.1 Source of Assessment	For the option selected in the Source Type on the Case Assessment, Vault finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name. `source_type__v.localized_controlled_vocabulary__v.name__v` If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Source (text). `localized_case_assessment_result__v.source_text__v` If the above is not available, Vault maps the Case Assessment Result object Source (text). `case_assessment_result__v.source_text__v`
G.k.9.i.2.r.2 Method of Assessment	For the option selected in the Method of Assessment on the Case Assessment, Vault finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name. `method_of_assessment__v.localized_controlled_vocabulary__v.name__v` If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Method (text). `localized_case_assessment_result__v.method_text__v` If the above is not available, Vault maps the Case Assessment Result object Method (text). `case_assessment_result__v.method_text__v`
G.k.9.i.2.r.3 Result of Assessment	Vault finds the record Name of the Assessment Result (Override) Controlled Vocabulary. `assessment_result_override__v.localized_controlled_vocabulary__v.name__v` Note Your Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your Vault. In addition, there is a limitation with the Assessment Result (Override) Controlled Vocabulary where Vault will find the English record Name instead of the Japan Localized record. This limitation will be addressed in a future release. If the Assessment Result (Override) is not available, Vault finds the corresponding Japan Localized Controlled Vocabulary for the Assessment Result value on the Case Assessment and maps the record Name. `assessment_result__v.localized_controlled_vocabulary__v.name__v` If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Result (text). `localized_case_assessment_result__v.result_text__v` If the above is not available, Vault maps the Case Assessment Result object Result (text). `case_assessment_result__v.result_text__v`

For the option selected in the Source Type on the Case Assessment, Vault finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name.
source_type__v.localized_controlled_vocabulary__v.name__v

If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Source (text).
localized_case_assessment_result__v.source_text__v

If the above is not available, Vault maps the Case Assessment Result object Source (text).
case_assessment_result__v.source_text__v

G.k.9.i.2.r.2 Method of Assessment

For the option selected in the Method of Assessment on the Case Assessment, Vault finds the corresponding Japan Localized Controlled Vocabulary and maps the record Name.
method_of_assessment__v.localized_controlled_vocabulary__v.name__v

If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Method (text).
localized_case_assessment_result__v.method_text__v

If the above is not available, Vault maps the Case Assessment Result object Method (text).
case_assessment_result__v.method_text__v

G.k.9.i.2.r.3 Result of Assessment

Vault finds the record Name of the Assessment Result (Override) Controlled Vocabulary. assessment_result_override__v.localized_controlled_vocabulary__v.name__v

Note Your Admin must add the Assessment Result (Override) field to the layout and Veeva Support must enable this usage in your Vault. In addition, there is a limitation with the Assessment Result (Override) Controlled Vocabulary where Vault will find the English record Name instead of the Japan Localized record. This limitation will be addressed in a future release.

If the Assessment Result (Override) is not available, Vault finds the corresponding Japan Localized Controlled Vocabulary for the Assessment Result value on the Case Assessment and maps the record Name.
assessment_result__v.localized_controlled_vocabulary__v.name__v

If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Result (text).
localized_case_assessment_result__v.result_text__v

If the above is not available, Vault maps the Case Assessment Result object Result (text).
case_assessment_result__v.result_text__v

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 text from the Reporter's Comments field on the Japan Localized Case, to a limit of 20,000 characters.

H.4 Sender's Comments

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 text from the Reporter's Comments field 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`

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. `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. `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). `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 entered in the Transmission Date field on the Transmission (Submission or Distribution) record. 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

Note For Vault to generate this value, all three fields must be populated. If any field is blank, this data element is not exported.

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 Note For Vault to generate this value, all three fields must be populated. If any field is blank, this data element is exported with no value populated. 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 entered 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 entered 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 entered 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 Vault first finds any file attached to the Case with the document type of Case > Source > Attachment. Then, Vault retrieves the corresponding Japanese Localized Case Document and populates this element with the Attachment Description, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank. localized_case_document__v.attachment_description__v

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

E2B Data Element Name	Populated Value
C.1.6.1.r.1 Documents Held by Sender	Vault first finds any file attached to the Case with the document type of Case > Source > Attachment. Then, Vault retrieves the corresponding Japanese Localized Case Document and populates this element with the Attachment Description, to a limit of 2,000 characters. This field is mapped even when the document is a placeholder or blank. `localized_case_document__v.attachment_description__v`
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 or blank, they are encoded. If the Retransmit field is set to No, documents are not encoded.

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 entered 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 populated in the Country field on the primary Reporter-type Case Contact. This field is only transmitted 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 selected 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)	Vault first finds any Case attachments with the document type of Case > Source > Literature. Then, Vault retrieves the corresponding Japanese Localized Case Document and populates this element with the Reference, to a limit of 500 characters. `localized_case_document__v.reference_text__v`

C.5 Study Identification

E2B Data Element Name	Populated Value
C.5.2 Study Name	The value entered 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.

E2B Data Element Name

Populated Value

C.5.2 Study Name

The value entered 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 nullFlavour `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 nullFlavour `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 nullFlavour `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 nullFlavour `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 nullFlavour `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 entered 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 Parental-type Case. 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 entered in the Medical History Text field, to a limit of 10,000 characters, from the Localized Case for the associated Parental-type Case.

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 Parental-type Case 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 entered 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 information entered 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 entered in the Test Result (Qualifier) and (Number) fields on the Case Test Result. In accordance with ICH guidelines, this element is not populated if the Test Result (code) (F.r.3.1) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, this element is not populated. Instead, the Test Result (Number) and Result (Unit) Text fields are mapped to F.r.3.4.
F.r.3.4 Result Unstructured Data (free text)	The information entered in the Result (Text) field on the Japan Localized Case Test Result. In accordance with ICH guidelines, Vault adheres to the following rules when mapping this field: This field allows numeric values only and is not mapped if the value entered contains non-numeric characters. This field is not populated if the Test Result (code) (F.r.3.1) or F.r.3.2 Test Result (value / qualifier) is provided. Note When the Test Result (Number) field is populated but the Test Result (Unit) field is blank, if there is a value in the Result (Unit) Text field, the number and unit text are populated in this element. `localized_case_test_result__v.result_text__v`
F.r.6 Comments (free text)	The information entered 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:

Case Product Registrations with a Drug Role of "Suspect"
Company Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
External Product-type Case Products with a Drug Role of "Suspect" that do not have a Case Product Registration in Japan
Case Product Registrations with a Drug Role of "Interacting"
Case Product Registrations with a Drug Role of "Concomitant"
Case Product Registrations without a Drug Role
Company Product-type Case Products that do not have a Case Product Registration in Japan
External Product-type Case Products that do not have a Case Product Registration in Japan

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:

Case Products with a Drug Role of "Suspect"
Case Products with a Drug Role of "Interacting"
Case Products with any other Drug Role

E2B Data Element Name Populated Value

G.k.5a Cumulative Dose to First Reaction (number)

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

G.k.5b Cumulative Dose to First Reaction (unit)

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

G.k.11 Additional Information on Drug (free text)

The information entered 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 code on the Localized Case Product. If a Case Product includes multiple Substances, Vault exports a Substance code as described above for only the first Substance on the Product record. If a Case Product is blinded, Vault exports a Substance 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 this value from the Local Product Code field. `localized_case_product_substance__v.local_product_code__v` If the Local Product Code is blank, Vault then attempts to map the Name (Reported) field. `localized_case_product_substance__v.name_reported__v` If the Name (Reported) is also blank, then Vault maps the Name (Reported) field on the Case Product Substance from the global Case. `case_product_substance__v.name_reported__v`
G.k.2.3.r.2a Substance / Specified Substance TermID Version Date/Number	The value entered in the TermID Version 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.2b Substance / Specified Substance TermID	The value entered 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 entered 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 selected 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 only transmitted 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 only transmitted 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 only transmitted 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 entered 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 selected 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 information entered in the Batch/Lot Number field on the Case Product Dosage. This element is not transmitted when nullFlavours 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. `case_product_dosage__v.dose_form__v.localized_dose_form__v.e2b_code__v`
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number	The information entered in the Dose Form TermID Version field on the Case Product Dosage.
G.k.4.r.9.2b Pharmaceutical Dose Form TermID	The information entered in the Dose Form TermID field 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 maps the value from the Patient RoA field. `localized_case_product_dosage__v.patient_adminroute_text__v`
G.k.4.r.10.2a Route of Administration TermID Version Date / Number	The information entered in the Patient RoA TermID Version field 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. `case_product_dosage__v.patient_adminroute__vr.e2b_code__v`
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 maps the Patient RoA Text field. `localized_case_product_dosage__v.parent_adminroute_text__v`
G.k.4.r.11.2a Parent Route of Administration TermID Version Date / Number	The information entered in the Parent RoA TermID Version field 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. `case_product_dosage__v.parent_adminroute__vr.e2b_code__v`

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

If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Source (text).
localized_case_assessment_result__v.source_text__v

If the above is not available, Vault maps the Case Assessment Result object Source (text).
case_assessment_result__v.source_text__v

G.k.9.i.2.r.2 Method of Assessment

If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Method (text).
localized_case_assessment_result__v.method_text__v

If the above is not available, Vault maps the Case Assessment Result object Method (text).
case_assessment_result__v.method_text__v

G.k.9.i.2.r.3 Result of Assessment

Vault finds the record Name of the Assessment Result (Override) Controlled Vocabulary. assessment_result_override__v.localized_controlled_vocabulary__v.name__v

If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Result (text).
localized_case_assessment_result__v.result_text__v

If the above is not available, Vault maps the Case Assessment Result object Result (text).
case_assessment_result__v.result_text__v

H Narrative Case Summary and Further Information

E2B Data Element Name Populated Value

H.2 Reporter's Comments The text from the Reporter's Comments field 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

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. `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. `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). `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.

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`