**Source URL:** https://safety.veevavault.help/en/lr/827489/index.md # PMDA MHLW Paper Form Generation Data Mapping 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: * [Adverse Event/Infectious Disease Individual Report][1] * [Research Report][2] * [Safety Measure Report][3] 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/DD` format 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. * **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.
C.3.4.1–C.3.4.3 Sender's Street Address / Sender's City /
Sender's State or Province / Sender's Organization		 From the User record associated with the Sender (User) on the ICSR Transmission, Vault exports:
  • Street
  • City
  • State / Province
  • Organization

If the Transmission does not include a Sender (User), Vault maps these values based on the Organization on the Case.

Vault truncates any text that exceeds the 100-character limit for this data element.
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:
  1. Continuing: If a nullFlavor, Vault exports 継続不明(" + NullFlavor + "). For example, 継続不明("MSK"). If Yes, Vault exports 継続.
  2. End Date: The nullFlavor or date, using format YYYY/MM/DD.
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:
  • 重・非: Yes, highlighted by the reporter, NOT serious
  • 非・非: No, not highlighted by the reporter, NOT serious
  • 重・重: Yes, highlighted by the reporter, SERIOUS
  • 非・重: No, not highlighted by the reporter, SERIOUS
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:
  • 再発あり: yes - yes (rechallenge was done, reaction recurred)
  • 再発なし: yes - no (rechallenge was done, reaction did not recur)
  • 転帰不明: yes - unk (rechallenge was done, outcome unknown)
  • 再投与なし: no - n/a (no rechallenge was done, recurrence is not applicable)
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:
  • If complete, Vault exports 完了. For example, 継続不明("MSK").
  • Otherwise, Vault exports 未完了.
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:
  • 未知: Unexpected
  • 既知: Expected
If there are multiple products assigned a PMDA Rank and transmitted in section G.k, this element is transmitted only if the primary (Rank 1) PMDA product is the only Case Product with a Drug Role of Suspect>.
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:
  • 再発なし: Clinical trial/research
  • 非臨床: Non-clinical trial/research
[1]: #aer-report [2]: #research-report [3]: #sm-report