| 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:
- For Regenerative RF: Investigation Report of Regenerative Medicine Research Report:
RF
- For Regenerative RG: Investigation Report on Measures for Regenerative Medicines:
RG
|
| 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:
- For Device RF: Investigation Report of Regenerative Medicine Research Report:
研究報告
- For Device RG: Investigation Report on Measures for Regenerative Medicine:
措置報告
|
| 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.2.4 種別 (Type) |
If the Reason on the Transmission is Initial, Vault populates 初回報告. Otherwise, Vault populates 追加報告. |
| M.2.4.1 報告回数 (Number of reports) |
The Follow-up Number on the Transmission. |
| 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.3 第一報入手日 (First day of receipt) |
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. |
| Pa.8.1 医療機器の不具合状況 (Product malfunction status) |
Vault populates a value based on the Device Problem Status on the Local Reporting Details record. |
| Pa.8.3r 製品の不具合名 (Product defect name) |
The Defect Term on the Localized Case Product Device Code record. |
| Pa.9.1 患者等の健康被害状況 (Status of health damage to patients) |
Vault populates a value based on the Patient Health Effect Status on the Local Reporting Details record. |
| Pa.9.9r 患者等の健康被害名 (Name of health damage suffered by patients) |
Based on the Case Adverse Event related to the Case Assessment, Vault populates the Event (Reported) (Event (PT)). |
| M.6.1 担当者氏名 (Name of person in charge) |
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 住所 (Address) |
The address information from the Person associated with the Contact Person on the Local Reporting Details record. |
| M.6.5.1 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.6.5.2 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.6.5.3 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.6.6 E-mail |
The Email of the Person associated with the Contact Person on the Local Reporting Details record. |
| Pr.1 販売名 (Brand name) |
The Name of the Product on the primary Case Product Registration. |
| Pr.2 一般的名称 (General name) |
The Device/Product Generic Name on the primary Case Product Registration. |
| Pr.3 詳細情報 (Detailed information) |
The Device/Product Details on the primary Case Product Registration. |
| Pr.4 承認・認証・届出番号 (4) Approval, certification, and notification number) |
The Registration Number on the Product Registration related to the primary Case Product Registration. |
| Pr.5 条件・期限付き承認 (Conditional and time-limited approval) |
Vault populates a value based on the Regenerative Conditional Approval on the Case Product Registration. |
| Pr.6 分類 (Classification) |
Vault populates a value based on the Regenerative Classification on the Case Product Registration. |
| Pr.10 症例識別子 (Case Identifier) |
The UID on the Case Number record. |
| Pr.11 備考 (Notes) |
The Company Comments on the Localized Case. |
| Cb.1 研究報告の出典 (Research report source) |
If the PMDA Reporting Category on the Local Reporting Details record is Regenerative RF: Investigation Report of Regenerative Medicine Research Report, Vault populates the Reference Text on the earliest-created Localized Case Document. |
| Cb.2 措置実施国 (Countries implementing measures) |
If the PMDA Reporting Category on the Local Reporting Details record is Regenerative RG: Investigation Report on Measures for Regenerative Medicines, Vault populates the Name of the Country associated with the Publication Country on the earliest-created Localized Case Document. |
| Cb.3 措置区分 (Measures classification) |
If the PMDA Reporting Category on the Local Reporting Details record is Regenerative RF: Investigation Report of Regenerative Medicine Research Report, Vault populates a value based on the Measure Classification on the earliest-created Localized Case Document. |
| Cb.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 Regenerative RG: Investigation Report on Measures for Regenerative Medicines, Vault populates a value based on the Measures Classification Details on the earliest-created Localized Case Document. |
| Cb.5 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. |
| Cb.6.1 今後の対応区分 (Future actions) |
Vault populates a value based on the Device Future Action Classification on the Local Reporting Details record. |
| Cb.6.2 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. |
| S.1 報告日 (Report date) |
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. |