| Form 8 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 (Year) | The Reference Number Year on the Local Reporting Details record. |
| M.1.3 管理番号_管理番号 (Reference Number) | The Reference Number on the Local Reporting Details record. |
| M.2.1 報告の別 (Reporting category) | Vault populates a value based on the PMDA Reporting Category on the Local Reporting Details record:
|
| M.2.2 既知未知 (Expectedness) | If the Expected value on any Localized Case Assessment related to the primary Case Assessment is Yes, Vault populates 既知. Otherwise, Vault populates 未知. |
| M.2.3 報告期限 (Reporting due date) | 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 発生場所 (Location of occurrence) | If the Country on the primary Case Adverse Event is Japan, Vault populates 国内. Otherwise, Vault populates 外国. |
| M.2.5 種別 (Type of report) | If the Reason on the Transmission is Nullification, Vault populates 取下げ報告. Otherwise, Vault populates 報告回数. |
| M.2.5.1 報告回数 (Number of times reported) | 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 last 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 last 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.2.5.5 取下げ報告の理由_その他 (Reason for nullification report_Other) | If the Reason on the Transmission is Nullification, Vault populates Reason Text on the Transmission. |
| M.2.6 状態 (Status) | Vault populates a value based on the Completeness on the Local Reporting Details record. |
| M.2.6.1 状態の理由 (Reason for status) | If the Completeness on the Local Reporting Details record is Incomplete and 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 不具合発生日 (Date of defect) | The Device Event Date on the Local Reporting Details record. |
| M.4a 情報入手日 (Date information was obtained) | Vault populates the New Info Date on the Localized Case or, if blank, on the Case. |
| M.5a 報告日 (Date of report) | 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 of 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 of the Case Product Registration. |
| Pr.5.2 分類② (Classification 2) | Vault populates a value based on the Device Classification 2 of the Case Product Registration. |
| Pr.5.3 分類③ (Classification 3) | Vault populates a value based on the Device Classification 3 of the Case Product Registration. |
| Pr.6 併用医療機器 (Concomitant medical device) | If the Comments Label on the Localized Case Comment is Concomitant Therapy/Devices, 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. |
| Pa.1 患者略名 (Abbreviated name of patient) | Vault populates the Patient Initials on the Case and sets the unknownFlag to false. If Patient Initials is blank, Vault sets the unknownFlag to true. |
| Pa.2 年齢 (Age) | Vault populates the Age (normalized) on the Case and sets the unknownFlag to false. If Age (normalized) is blank, Vault sets the unknownFlag to true. |
| Pa.2.3 年齢_区分 (Age_type) | If the Age (normalized) is blank, Vault populates a value based on the Age Group on the Case. |
| Pa.2.1 年齢_年 (Age_Year) | The Age (normalized) on the Case. |
| Pa.2.2 年齢_単位 (Age_Unit) | If Age (normalized) has a value, Vault populates 歳. If blank but Age Group has a value, Vault populates 歳代. |
| Pa.3 性別 (Sex_type) | Vault populates a value based on the Sex on the Case:
|
| Pa.4 体重 (Weight) | Vault populates the Weight (normalized) on the Case and sets the unknownFlag to false. If Weight (normalized) is blank, Vault sets the unknownFlag to true. |
| Pa.5 身長 (Height) | Vault populates the Height (normalized) on the Case and sets the unknownFlag to false. If Height (normalized) is blank, Vault sets the unknownFlag to true. |
| Pa.6 転帰 (Outcome) | Vault populates a value based on the Device Outcome on the Local Reporting Details record. If Device Outcome is blank, but Device Outcome (Other) has a value, Vault populates その他. |
| Pa.6.1 転帰_その他 (Outcome_Other) | The Device Outcome (Other) on the Local Reporting Details record. |
| Pa.7.1 患者等の健康被害状況 (Health Damage of Patient) | Vault populates a value based on the Patient Health Effect Status on the Local Reporting Details record. |
| Pa.7.2r.2 健康被害状況コード (Health Damage Status Code) | If the Device Code Type on the Device-type Case Product is Health Effects - Clinical Signs and Symptoms or Conditions, Vault populates the Local Code on the Localized Case Product Device Code section, to a maximum of nine characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Pa.7.2r.1 健康被害名 (Health Damage Name) | If the Device Code Type on the Device-type Case Product is Health Effects - Clinical Signs and Symptoms or Conditions, Vault populates the Local Term on the Localized Case Product Device Code section, to a maximum of 255 characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Pa.7.2r.3 患者等の健康被害状況の疑い又はおそれ (Suspected or possible health damage situation of patient) | If the Device Code Type on the Device-type Case Product is Health Effects - Clinical Signs and Symptoms or Conditions, Vault populates a value based on the Possible Patient Health Damage value on the Localized Case Product Device Code. |
| Pa.8.1 医療機器の不具合状況 (Defects of medical devices) | Vault populates a value based on the Device Problem Status on the Local Reporting Details record. |
| Pa.8.2r.2 医療機器の不具合コード (Defect code of medical device) | If the Device Code Type on the Device-type Case Product is Medical Device Problem, Vault populates the Local Code on the Localized Case Product Device Code section, to a maximum of nine characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Pa.8.2r.1 医療機器の不具合名 (Defect name of medical device) | If the Device Code Type on the Device-type Case Product is Medical Device Problem, Vault populates the Local Term on the Localized Case Product Device Code section, to a maximum of 255 characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Pa.8.2r.3 医療機器の不具合の疑い又はおそれ (Suspected or threatened defect of medical device) | If the Device Code Type on the Device-type Case Product is Medical Device Problem, Vault populates a value based on the Possible Patient Health Damage on the Localized Case Product Device Code. |
| Pa.9 不具合等発生時の患者等の状況 (Situation of the patient at the time of the defect) | If the Comments Label on the Localized Case Comment is Course of Occurrence, 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. |
| Pa.10 患者等のためにとられた手当て (Treatment taken for the patient) | If the Comments Label on the Localized Case Comment is Treatments Taken for Patient, 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. |
| Ca.1 医療機器の使用状況 (Status of use of medical devices) | Vault populates a value based on the Device/Regenerative Usage Status on the Case Product Registration. |
| Ca.1.1 使用回数 (Number of times used) | The Device/Regenerative Usage Count on the Case Product Registration. |
| Ca.1.2 使用期間 (Period of use) | The Device/Regenerative Usage Period on the Case Product Registration. |
| Ca.1.3 使用期間_単位 (Period of use_Unit) | Vault populates a value based on the Device/Regenerative Usage Period (unit) on the Case Product Registration. |
| Ca.2 医療機器の現状 (Current status of medical devices) | Vault populates a value based on the Device/Product Collection Status on the Case Product Registration. |
| Ca.2.1 医療機器の現状_現品未回収詳細 (Current status of medical devices_Details of actual device not collected) | Vault populates a value based on the Uncollected Status on the Case Product Registration. |
| Ca.3.1r.2 調査方法コード (Investigation method code) | If the Device Code Type on the Device-type Case Product is Investigation Conclusion, Vault populates the Local Code on the Localized Case Product Device Code section, to a maximum of nine characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.1r.1 調査方法 (Investigation Method) | If the Device Code Type on the Device-type Case Product is Investigation Conclusion, Vault populates the Local Term on the Localized Case Product Device Code section, to a maximum of 255 characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.2r.2 調査結果コード (Investigation Result Code) | If the Device Code Type on the Device-type Case Product is Investigation Finding, Vault populates the Local Code on the Localized Case Product Device Code section, to a maximum of nine characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.2r.1 調査結果 (Investigation Results) | If the Device Code Type on the Device-type Case Product is Investigation Finding, Vault populates the Local Term on the Localized Case Product Device Code section, to a maximum of 255 characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.3r.2 結論コード (Conclusion Code) | If the Device Code Type on the Device-type Case Product is Investigation Conclusion, Vault populates the Local Code on the Localized Case Product Device Code section, to a maximum of nine characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.3r.1 結論 (Conclusion) | If the Device Code Type on the Device-type Case Product is Investigation Conclusion, Vault populates the Local Term on the Localized Case Product Device Code section, to a maximum of 255 characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.4 調査結果_詳細 (Investigation Result_Details) | If the Comments Label on the Localized Case Comment is Investigation Result, 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. |
| Ca.3.5r.2 不具合が発生した部品コード (Defective part code) | If the Device Code Type on the Device-type Case Product is Medical Device Component, Vault populates the Local Code on the Localized Case Product Device Code section, to a maximum of nine characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| Ca.3.5r.1 不具合が発生した部品 (Defective parts) | If the Device Code Type on the Device-type Case Product is Medical Device Component, Vault populates the Local Term on the Localized Case Product Device Code section, to a maximum of 255 characters. If multiple codes apply, Vault exports values in order of the creation date. On the PDF format, all codes after the first appear in the overflow section. |
| C.6.2 これまでの対応 (Actions taken to date) | 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. |