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:
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 ( |
| 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:
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:
|
| C.1.4 Date Report Was First Received from Source |
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 |
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 and the Retransmit field set to Yes or blank. Populated as False if the Retransmit field is set to No. |
| 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 and the Retransmit field set to Yes or blank. 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 ( 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 ( |
| 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:
|
| 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's Organisation | 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__v
|
| C.4.r.2 Included Documents | Any documents attached to the Case with the document type of Case > Source > Literature and the Retransmit field set to Yes are included with the transmission. |
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 values entered in the Study Name and Study Name (Continued) fields on the associated Japanese Localized Case, to a limit of 2,000 characters.
localized_study__v.study_name__v
|
| 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 entered 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 selected 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 entered in the Gestation field on the Case. |
| D.2.2.1b Gestation Period When Reaction/Event Was Observed in the Foetus (unit) | The unit selected in the Gestation (unit) field on the Case. |
| 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 entered in the Weight field on the Case. |
| D.4 Height (cm) | The value entered in the Height (normalized) field on the Case. |
| D.5 Sex | The option populated in the Gender field on the Case. |
| D.6 Last Menstrual Period Date | The date entered 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:
|
| 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 Gender field on the associated Parent-type 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.
|
||||||||||||||
| 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.
|
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| 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:
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. | ||||||||||||||
| 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.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.
|
||||||||||||||
| 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.
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:
For Company and External Products without a PMDA Rank, Vault maps data from the Localized Case Product:
|
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, Vault finds the corresponding Japan Localized Case Product Substance, and then maps the substance name using the following logic:
|
| 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. |
| G.k.2.3.r.2b Substance / Specified Substance TermID | The value entered in the TermID field on the Case Product Substance. |
| G.k.2.3.r.3a Strength (number) | The value entered in the Strength (Number) field on the Case Product Substance. |
| G.k.2.3.r.3b Strength (unit) | The unit selected in the Strength (Unit) field on the Case Product Substance. |
G.k.3 Holder and Authorisation / Application Number of Drug
| E2B Data Element Name | Populated Value |
|---|---|
| G.k.3.1 Authorisation / Application Number | 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. |
| G.k.4.r.1b Dose (unit) | The unit selected in the Dose (unit) field on the Case Product Dosage. |
| 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:
|
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 | 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. If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Source (text). If the above is not available, Vault maps the Case Assessment Result object Source (text). |
| 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. If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Method (text). If the above is not available, Vault maps the Case Assessment Result object Method (text). |
| 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. If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Result (text). If the above is not available, Vault maps the Case Assessment Result object Result (text). |
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 Text field 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:
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.
|
| 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:
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:
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
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 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.
|
| 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:
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 | The 2-letter 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, mapped from 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:
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:
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 ( |
| 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:
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 |
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 and the Retransmit field set to Yes or blank. 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 ( 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.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.3 Information on Sender of Case Safety Report
| E2B Data Element Name | Populated Value |
|---|---|
| C.3.2 Sender's Organisation | 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__v
|
C.5 Study Identification
| E2B Data Element Name | Populated Value |
|---|---|
| C.5.2 Study Name | The values entered in the Study Name and Study Name (Continued) fields on the associated Japanese Localized Case, to a limit of 2,000 characters.
localized_study__v.study_name__v
|
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:
|
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:
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.
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.11 Additional Information on Drug (free text) | The information entered in the Additional Information (text) field on the Localized Case Product record.
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:
For Company and External Products without a PMDA Rank, Vault maps data from the Localized Case Product:
|
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, Vault finds the corresponding Japan Localized Case Product Substance, and then maps the substance name using the following logic:
|
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.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 | 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. If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Source (text). If the above is not available, Vault maps the Case Assessment Result object Source (text). |
| 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. If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Method (text). If the above is not available, Vault maps the Case Assessment Result object Method (text). |
| 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. If the above is not available, Vault finds the Japan Localized Case Assessment Result and maps the Result (text). If the above is not available, Vault maps the Case Assessment Result object Result (text). |
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 Text field 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:
If there is no match but there is a Comment with no Local Reporting Details specified, Vault selects that Comment. The H.4 Sender's Comments field is then mapped to the Comments Text of the selected Case Comment. localized_case_comment__v.comments_text__v
|
Section J
| E2B Data Element Name | Populated Value |
|---|---|
| J2.1a PMDA Reporting Category | The E2B code corresponding to the PMDA Reporting Category of the Local Reporting Details related to the Transmission.
transmission__v.local_reporting_details__v.
|
| 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:
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:
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
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 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.
|
| 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:
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 | The 2-letter 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, mapped from 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:
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
|