| 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 RA: Domestic AE:
RA
- For Regenerative RB: Domestic Infection:
RB
- For Regenerative RC: Foreign AE:
RC
- For Regenerative RD: Foreign Infection:
RD
|
| 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 Regenerative RA: Domestic AE or Regenerative RC: Foreign AE:
感染症
- For Regenerative RB: Domestic Infection or Regenerative RD: Foreign Infection:
不具合（副作用を含む)
|
| M.2.2 国内外の別 (Domestic and Overseas) |
If the Country of the primary Case Adverse Event is Japan, Vault populates 国内. Otherwise, Vault populates 外国. |
| 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) |
Vault populates a value based on the Reason on the Transmission. |
| M.2.4.1 報告回数 (Number of reports) |
The Follow-up Number on the Transmission. |
| M.2.4.2 理由 (Reason) |
If the Reason on the Transmission is Nullification, Vault populates the Reason Text on the Transmission. |
| M.2.5 即時報告 (Instant Report) |
If Immediate Report Type on the Local Reporting Details record has a value, Vault populates 該当. Otherwise, Vault populates 非該当. |
| 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 Initial Receipt Date on the Localized Case or, if blank, the New Info Date on the Case. |
| M.4a 報告起算日 (Reporting start date) |
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 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. |
| 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.2.1 年齢 (Age) |
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.2.3 年齢_区分 (Age rating) |
If the Age (normalized) is blank, Vault populates a value based on the Age Group on the Case. |
| Pa.3 性別 (Gender) |
Vault populates a value based on the Sex on the Case:
- For Male: Vault populates
男 and sets the unknownFlag to false
- For Female: Vault populates
女 and sets the unknownFlag to false
- Otherwise, Vault sets the unknownFlag to
true
|
| 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 原疾患 (Primary disease) |
If the Comments Label on the Localized Case Comment is Primary Disease, 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.7 合併症 (Complications) |
If the Comments Label on the Localized Case Comment is Complications, 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.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.1 医療機器の不具合名 (Defect name of medical device) |
The Defect Term on the Localized Case Product Device Code record. |
| Pa.8.2r.2 既知未知 (Known and Unknown) |
If the Defect Expected value on the Localized Case Product Device Code record is Yes, Vault populates 既知. Otherwise, Vault populates 未知. |
| Pa.8.2r.3 発生日 (Date of occurrence) |
The Device Event Date on the Local Reporting Details 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.9.2r.1 副作用・感染症名 (Side effects and infection names) |
Based on the Case Adverse Event related to the Case Assessment, Vault populates the Event (Reported) (Event (PT)). |
| Pa.9.2r.2 既知未知 (Known and Unknown) |
If the Expected value on the Case Assessment is Yes, Vault populates 既知. Otherwise, Vault populates 未知. |
| Pa.9.2r.3 発現日 (Date of onset) |
The Onset (normalized) on the Case Adverse Event. |
| Pa.9.2r.4 転帰日 (Outcome date) |
The Cessation (normalized) on the Case Adverse Event. |
| Pa.9.2r.5 重篤性 (Severity) |
Vault populates a value based on the Seriousness on the Case Adverse Event, using the following priority order:
- Results in death:
死に至るもの
- Disabling / incapacitating:
人体の構造又は機能の永続的な障害に至るもの
- Life threatening:
生命を脅かす疾病又は障害に至るもの
- Caused / prolonged hospitalisation:
入院又は入院期間の延長が必要となるもの
- Congenital anomaly / birth defect:
先天異常又は胎児の死亡若しくは機能不全を来すもの
- Other medically important condition:
その他の医学的に重要な
- Required Intervention to Prevent Permanent Impairment/Damage (Devices):
その他の医学的に重要な
|
| Pa.9.2r.6 転帰 (Outcome) |
Vault populates a value based on the Outcome on the Case Adverse Event:
- For fatal (E2B code
5): 死亡
- For not recovered/not resolved/ongoing (E2B code
3): 未回復
- For recovering/resolving (E2B code
2): 軽快
- For recovered/resolved (E2B code
1) or recovered/resolved with sequelae (E2B code 4): 回復
- Otherwise,
その他
|
| Pa.9.2r.7.1 因果関係評価_担当医等 (Causal relationship assessment - attending physician, etc.) |
If the Source on the Case Assessment Result is Health Care Professional (E2B code 5), Vault exports a value based on the Assessment Result on the Case Assessment Result as follows:
不明: For Unassessable/Unclassifiable関連あり: For For Possible, Probable / Likely, Reasonable Possibility, or Related関連なし: For For No Reasonable Possibility, Not Related, or Unlikely情報入手不能: If blank |
| Pa.9.2r.7.2 因果関係評価_報告者 (Causal relationship assessment - reporter) |
If the Source on the Case Assessment Result is Sponsor (E2B code 2) or Marketing Authorization Holder (E2B code 4), Vault exports a value based on the Assessment Result on the Case Assessment Result as follows:
不明: For Unassessable/Unclassifiable関連あり: For Possible, Probable / Likely, Reasonable Possibility, or Related関連なし: For No Reasonable Possibility, Not Related, or Unlikely情報入手不能: If blank |
| Pa.10 不具合等発生時の患者等の状況・経過 (The condition and progress of the patient when the malfunction occurred) |
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. |
| 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 承認番号 (Approval 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.7 使用状況区分 (Usage classification) |
Vault populates a value based on the Device/Regenerative Usage Status on the Case Product Registration as follows:
使用後: For First Usage, Usage Count, or Usage Period使用前: For Before Use |
| Pr.7.1 使用後 (After use) |
Vault populates a value based on the Device/Regenerative Usage Status on the Case Product Registration as follows:
True: For First Usage, Usage Count, or Usage Periodunknown: For Unknownfalse: In all other cases |
| Pr.7.1 使用期間 (During use) |
The Device/Regenerative Usage Period on the Case Product Registration. |
| Pr.7.2 使用期間_単位 (Usage period unit) |
Vault populates a value based on the Device/Regenerative Usage Period (unit) on the Case Product Registration. |
| Pr.8 現状区分 (Current status classification) |
Vault populates a value based on the Device/Product Collection Status on the Case Product Registration. |
| Pr.9 併用療法 (Combination therapy) |
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. |
| 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. |
| Ca.1 調査結果 (Survey results) |
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. |
| C.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. |
| C.6.1 今後の対応区分 (Future response categories) |
Vault populates a value based on the Device Future Action Classification on the Local Reporting Details record. |
| C.6.2 今後の対応 (Future Actions) |
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 (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's Role) |
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. |