Learn how Vault generates standard PMDA MHLW Paper Forms from a Case.
About PMDA MHLW Paper Form
For Japan domestic Cases and Localized Cases, you can generate reports in the PMDA MHLW Paper Format. Vault maps all Case data and documents to the applicable forms and fields using the same data element mapping as the PMDA E2B(R3), with some unique logic. You can view the forms and required data mapping on the PMDA website.
Vault generates report types and standard forms based on the PMDA Reporting Category in the Local Reporting Details record of the Case or Localized Case. The available report types are:
For all generated pages, a header indicates the page number and total number of pages for the report. If data spans multiple pages in a report section, Vault inserts a page break at the end of the section.
Adverse Event/Infectious Disease Individual Report
Vault generates the Adverse Event/Infectious Disease Individual Report paper forms for individual case reports when the PMDA Reporting Category is AA, AB, AC, AD, DA, DB, DC, or DD. This report type includes the following standard forms:
- Cover Form 1: Case Information
- Detail Forms:
- 2-1: Suspect Products/Reporter/Attachments/Study Information
- 2-2: Patient/Medical History/Drug/Adverse Events/Narrative Information
- 2-3: Test Results Information
- 2-4: Additional Drug Information/Assessments
- 2-5: Narratives / Case Comments
- 2-6: Parent Information
Research Report
Vault generates the Research Report paper forms for Research Reports when the PMDA Reporting Category is AE, AF, DE, or DF. This report type includes the following standard forms:
- Cover Form 3: Case Information
- Detail Forms:
- 4-1: Suspect Products/Reporter/Publication Country/Study Information
- 4-2: Narratives
Safety Measure Report
Vault generates the Safety Measure Report, also known as the Foreign Measure Report, paper forms for Safety Measure Reports when the PMDA Reporting Category is AG or DG. This report type includes the following standard forms:
- Cover Form 5: Case Information
- Detail Forms:
- 6-1: Suspect Products/Reporter/Publication Country/Study Information
- 6-2: Narratives
PMDA MHLW Paper Form Data Output
Although the PMDA MHLW Paper Forms use the same general data mapping as the PMDA E2B(R3) report, there is some unique export logic:
- NullFlavors: Where exported values are nullFlavors, unless otherwise indicated, Vault exports
不明(" + NullFlavor + "). For example,不明("MSK"). - Yes/True: Vault exports
はいor有. - No/False/None: Vault exports
いいえor無. - Dates and Times: Vault exports dates in
YYYY/MM/DDformat and converts times to Japan Standard Time (JST).- The exception is the N.1.5 Date of Batch Transmission data element. Vault exports dates in
YYYY年MM月DD日format.
- The exception is the N.1.5 Date of Batch Transmission data element. Vault exports dates in
- Controlled Vocabulary: Vault exports Japanese translations of Controlled Vocabulary terms when applicable. For example, to the C.3.1 Sender Type, C.1.3 Type of Report, and C.2.r.4 Qualification data elements.
- Character limits: When a value exceeds the character limit of a data element, Vault populates
以下省略、全体は別添参照and includes the information as an attachment. - Record overflow: When there is more than one (1) record to display in the Product and Substance section of the first table of Forms 1, 3, and 5, Vault displays the second and subsequent records in the overflow section of the next page.
Data Element Export Logic
The following table lists special export logic for PMDA MHLW Paper Forms by data element:
| Data Element | Populated Value |
|---|---|
| C.1.8.2 First Sender of This Case | For E2B Code 1, Vault exports 規制当局. For E2B Code 2, Vault exports その他. |
| C.1.9.1 Other Case Identifiers in Previous Transmissions | If there are any Case Identifier objects associated with the Case, Vault exports はい (True). Otherwise, Vault exports 不明(NI). |
| C.2.r.5 Primary Source for Regulatory Purposes | For each Reporter-type Case Contact with a Primary Source field value of Yes, Vault exports 一次情報源. |
| D.7.1.r.4/D.7.1.r.3 End Date / Continuing | For each Localized Case Medical History record, Vault exports a field value from the Case Medical History record using the following priority order:
|
| E.i.3.1 Term Highlighted by the Reporter | For each Case Adverse Event reported by the primary source, a code based on the Highlighted Term field:
|
| E.i.3.2a-E.i.3.2f Results in Death, Life Threatening, Caused / Prolonged Hospitalisation, Disabling / Incapacitating, Congenital Anomaly / Birth Defect, Other Medically Important Condition | If the Seriousness field is blank on all Case Adverse Events, Vault exports 非重篤. |
| G.k.2.5 / Investigational Product Blinded | For each exported Case Product with a Drug Role of Suspect or Interacting for which the J2.4.k License Category of New Drug data element has a value, Vault exports 盲検下 for blinded Case Products. |
| G.k.9.i.4 Did Reaction Recur on Re-administration? | A code based on the Reaction Recurrence field value on the Case Assessment record:
|
| J2.3 Flag for Immediate Report | If the Immediate Report Type field value on the Local Reporting Details record related to the Transmission is System (E2B), Vault exports 即時報告. |
| J2.7.1 Completion flag | A value based on the Completeness field of the Local Reporting Details record related to the Transmission:
|
| J2.8.1 Downgrade Report | If the Downgraded field value on the Transmission is Yes, Vault exports 報告対象外. |
| J2.14.i Expectedness | For each Case Adverse Event reported by the primary source, a code based on the Expected field of the Localized Case Assessment record related to the primary PMDA product under the Japan Localized Case:
|
| J2.17.r Classification of trial/research | Based on the value in the Literature Classification field on each Localized Case Document exported to the C.4.r.1 Literature Reference(s) data element, Vault exports:
|