Veeva Safety supports PMDA postmarket medical device and regenerative medicine forms. When you export a postmarket Case to PMDA Form 10, Vault maps all data and documents to the standard PMDA form for medical device research reports and investigation reports on measures taken in foreign countries. Vault formats the document as a PDF (PMDA Form 10 (PDF)) or an XML file (PMDA Form 10 (XML)) based on the Transmission Document Type you select during Transmission generation.
Form 10 Field Mapping
The form fields include:
| Form 10 Field | Data Source |
|---|---|
| M.1.1 管理番号_報告分類 | Vault populates a code based on the PMDA Reporting Category on the Local Reporting Details record:
|
| M.1.2 管理番号_管理年度 (Management Year) | The Reference Number Year on the Local Reporting Details record. |
| M.1.3 管理番号_管理番号 (Management Number) | The Reference Number on the Local Reporting Details record. |
| M.2.1 報告区分 (Report distinction) | Vault populates a value based on the PMDA Reporting Category on the Local Reporting Details record:
|
| M.2.3 報告期限 (Reporting period) | If the Due in Days value on the Primary Case Product Registration on the Local Reporting Details record is 15, Vault populates 15日. Otherwise, Vault populates 30日. |
| M.2.5.1 報告回数 (Number of reports) | The Follow-up Number on the Transmission. |
| M.2.5.2 前回報告時受理番号_年度 (Receipt number of the previous report_Year) | The Previous Reference Number Year on the Local Reporting Details record. |
| M.2.5.3 前回報告時受理番号_登録番号 (Receipt number from previous report_Registration number) | The Previous Reference Number on the Local Reporting Details record. |
| M.2.5.4 取下げ報告の理由 (Reason for nullification report) | Vault does not populate this field. |
| M.2.6 状態 (Situation) | Vault populates a value based on the Completeness on the Local Reporting Details record. |
| M.2.6.1 状態の理由 (Reason) | If the Comments Label on the Localized Case Comment is J2.7.2 Comments on Completeness, Vault populates the Comments Text on the Localized Case Comment. If multiple records meet this criteria, Vault exports the Comments Text from all Localized Case Comment records, up to 10,000 characters. |
| M.4a 情報入手日 (Date of information acquisition) | Vault populates the New Info Date on the Localized Case or, if blank, the New Info Date on the Case. |
| M.5a 報告日 (Reporting date) | The Transmission Date on the Transmission. |
| M.6.1 担当者氏名 (Name of Contact Person) | The Name of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.2 企業名 (Company name) | The Organization of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.3 部署 (Department) | The Department of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.4.1 Tel_市外局番 (Tel_area code) | The Telephone Country Code of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.4.2 Tel_市内局番 (Tel_Local Area Code) | The first four digits of the Telephone value of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.4.3 Tel_加入者番号 (Tel_Subscriber Number) | The last four digits of the Telephone value of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.5 E-mail | The Email of the Person associated with the Contact Person on the Local Reporting Details record. |
| M.7 症例識別子 (Case identifier) | The UID on the Case Number record. |
| Pr.1 販売名 (Trade name) | The Name of the Product on the primary Case Product Registration. |
| Pr.2.2 一般的名称コード (Generic name code) | The JMDN Code on the primary Case Product Registration. |
| Pr.2.1 一般的名称 (Generic name) | The Device/Product Generic Name on the primary Case Product Registration. |
| Pr.3 詳細情報 (Detailed information) | The Device/Product Details value on the primary Case Product Registration. |
| Pr.4 承認・認証・届出番号 (4) (Approval/certification/notification number) | The Registration Number on the Product Registration related to the primary Case Product Registration. |
| Pr.5.1 分類① (Classification 1) | Vault populates a value based on the Device Classification 1 on the Case Product Registration. |
| Pr.5.2 分類② (Classification 2) | Vault populates a value based on the Device Classification 2 on the Case Product Registration. |
| Pr.5.3 分類③ (Classification 3) | Vault populates a value based on the Device Classification 3 on the Case Product Registration. |
| Cc.1 研究報告の出典 (Research report source) | If the PMDA Reporting Category on the Local Reporting Details record is Device DF: Investigation Report of Medical Device Research Report, Vault populates the Reference Text on the earliest-created Localized Case Document. |
| Cc.2 措置実施国 (Countries implementing measures) | If the PMDA Reporting Category on the Local Reporting Details record is Device DG: Investigation Report on Measures such as Discontinuation of Manufacturing, Recall, or Disposal in Foreign Countries for Medical Devices, Vault populates the Name of the Country associated with the Publication Country on the Localized Case Document. |
| Cc.3 措置区分 (Measure classification) | If the PMDA Reporting Category on the Local Reporting Details record is Device DG: Investigation Report on Measures such as Discontinuation of Manufacturing, Recall, or Disposal in Foreign Countries for Medical Devices, Vault populates a value based on the Measure Classification on the Localized Case Document. |
| Cc.4 研究報告又は措置内容_詳細 2)これまでの対応 (Research report or details of measures taken 2) Past responses) | If the PMDA Reporting Category on the Local Reporting Details record is Device DG: Investigation Report on Measures such as Discontinuation of Manufacturing, Recall, or Disposal in Foreign Countries for Medical Devices, Vault populates a value based on the Measures Classification Details on the Localized Case Document. |
| C.6.2 これまでの対応 (Past responses) | If the Comments Label on the Localized Case Comment is Device/Regenerative Action Taken, Vault populates the Comments Text on the Localized Case Comment. If multiple records meet this criteria, Vault exports the Comments Text from all Localized Case Comment records, up to 10,000 characters. |
| C.7.1 今後の対応区分 (Classification of future actions) | Vault populates a value based on the Device Future Action Classification on the Local Reporting Details record. |
| C.7.2 今後の対応 (Future action to be taken) | If the Comments Label on the Localized Case Comment is Device/Regenerative Future Action, Vault populates the Comments Text on the Localized Case Comment. If multiple records meet this criteria, Vault exports the Comments Text from all Localized Case Comment records, up to 10,000 characters. |
| R.1 備考欄 (Remarks) | The Company Comments on the Localized Case. |
| S.1 報告日 (Date of report) | The Transmission Date on the Transmission. |
| S.2 送信者住所 (Sender's address) | The address information from the User associated with the Sender (User) on the Transmission. |
| S.3 送信者役職 (Sender Title) | The Title on the User associated with the Sender (User) on the Transmission. |
| S.4 送信者氏名 (Sender's Name) | The Name on the User associated with the Sender (User) on the Transmission. |
| S.6 受信者役職 (Recipient Title) | The Title on the Person associated with the Receiver Person on the Transmission Profile. |
| S.7 受信者氏名 (Recipient Name) | The First Name and Last Name on the Person associated with the Receiver Person on the Transmission Profile. |