Processing tab actions
The following right-click options are available anywhere in the Processing table rows:
評価 (Assessment)
| Japanese field name | English field name | Description |
|---|---|---|
| 評価結果 | Assessment Result | This drop-down is blank at first. |
| 研究報告の理由 | Reason of Research Report | Section title |
| がんその他の重大な疾病、障害若しくは死亡が発生するおそれ | Possibility of occurrence of serious disease such as cancer, disorder, or death | There are two radio button options: 有 (Yes) and 無 (No), with the default set to NO. |
| 副作用又は感染症の発生数、発生頻度、発生条件の著しい変化 | Significant change on event or infection occurrence number, frequency, and condition. | There are two radio button options: 有 (Yes) and 無 (No), with the default set to NO. |
| 承認を受けた効能若しくは効果を有しないこと | It doesn’t have acknowledged effectiveness | There are two radio button options: 有 (Yes) and 無 (No), with the default set to NO. |
| 評価コメント | Assessment Comment | This field displays the assessment comments. |
| 問題点 | Problems | This text field has a length limit of 20000. |
| 取消 | Cancel | |
| Reason for Not Necessary | 不要な理由 | This field displays the reason when Assessment
Result is 不要 (Not Necessary). The available options are:
|
| English option name | Japanese option name | Reporting Category | Case Form mapping | Value displayed on the second Assessment column |
|---|---|---|---|---|
| Not Necessary | 不要 | N/A | If this option is selected, the data item is moved to the Processed tab after the Create Case > Process Unnecessary assessment action. | 不要 |
| AE Case | 副作用症例 | A, B, C, D, H, I, J, K | If this option is selected, the data is moved to the Processed
tab after the Create Case > Process Unnecessary assessment action.
These items are entered as regular Cases from the Book-in window. |
副作用症例 |
| Research/Infection report (Marketed drug) | 感染症研究報告（市販後） | E | Analysis > PMDA General tab > Reporting Category | 研究報告 |
| Research/ADR report (Marketed drug) | 副作用研究報告（市販後） | F | Analysis > PMDA General tab > Reporting Category | 研究報告 |
| Measures in foreign countries including discontinuation of manufacture, recall and withdrawn (Marketed drug) | 外国における製造中止、回収、廃棄等の措置報告(市販後） | G | Analysis > PMDA General tab > Reporting Category | 措置報告 |
| Research/Infection report (Investigational drug) | 感染症研究報告(治験） | L | Analysis > PMDA General tab > Reporting Category | 研究報告 |
| Research/ADR report (Investigational drug) | 副作用研究報告（治験） | M | Analysis > PMDA General tab > Reporting Category | 研究報告 |
| Measures in foreign countries including discontinuation of manufacture, recall and withdrawn (Investigational drug) | 外国における製造中止、回収、廃棄等の措置報告(治験） | N | Analysis > PMDA General tab > Reporting Category | 措置報告 |
| Research report (Quasi drug) | 医薬部外品研究報告 | O | Analysis > PMDA General tab > Reporting Category | 研究報告 |
| Research report (Cosmetics) | 化粧品研究報告 | P | Analysis > PMDA General tab > Reporting Category | 研究報告 |
When you select one of the above Research reporting category ( E, F, L, M, O and P), at least one of the three radio buttons needs to be set to Yes.
When the case book-in occurs from Literature Intake, if the assessment result have the item 3 to 10 from above, the Book-in automatically populates and encodes 副作用無し (No Events) in the Event field of the book-in window. Otherwise, the Event field is blank.
複数評価 (Multiple Assessment)
When you select this option, you can perform assessment for all selected row items. The assessment made from this option updated all the selected items.
症例の作成/不要評価の処理 (Create case/Process unnecessary assessment)
- If Assesment for literature data is set to Not Necessary, then that data is moved to the Processed tab.
- If Assesment for literature data is set to options 2-10 form the above specified table, the Book-in window opens with all the Literature data populated. Assessment Results from the above table (2-10) are copied to Case Data while book-in is performed on the case.
- When you select Create case/Process unnecessary assessment, the system checks whether there is a valid Japanese License available in that product family. If the product family does not have any Japanese licenses, The book-in fails and the following warning message is displayed: この製品系統群には有効な日本のライセンスが存在しません。 (This product family doesn’t have valid Japanese licenses.). When this happens, the Book-in screen opens, but the product is not displayed on the screen.
- If a matching product family no longer exists at the time of book-in, the product is not populated in the Book-in screen.
- If assesment is not completed for literature data and you select the Create case/Process unnecessary assessment option, then the following error message 評価結果が存在しません。 (Assessment result doesn’t exist.) is not displayed and case creation is perfomed and the Book-in screen is displayed.
- If the case has been created without specifying the Assessment in the Processing tab, then the Processed tab displays the values for Assigned, Assessment and Assesment Date as blank.
- The book in executable one at a time.
- Once booking is complete, the system displays the following message: 新しい症例"2009JP000085"の作成に成功しました。この症例を開きますか？ (New case xxxxxxxxxxx successfully created. Do you want to open the case?). If you select はい (Yes), the created case opens. If you select いいえ (No), then you are re-directed to the Processing tab of the Literature intake table.
- Once booking is complete, the processed item is moved to the Processed tab.
- When the book-in is processed from this place, it always is a Japanese book-in.
- Initial Receipt Date=Import Date
- Report Type=Default value configured in profile switch
- If the Default Report type common profile switch is selected when the Literature Intake item is booked-in option is not set, then no literature information is displayed in the Book-in window. Thus, make sure to set the Literature Intake item is booked-in option.
- Product Name is populated with the ; special character to separated family names that belong to the same Search Equation Number. This field is read-only. When the case is generated, all Japanese licenses are populated in the case.
- When the product is populated in the case created through J
Literature Intake module, it only populates one record in the Case
Form Products tab for each Product in the matching Product Family.
If there are multiple Japanese licenses for a product, then the
correct license is picked up, based on the following logic:
- License Authorization Country = Japan
- Withdrawn date is blank or >= current system date
- Hide checkbox is not marked as checked for that product license combination
- Not in Tradename lookup/Not Autoscheduled checkbox is not set as checked
- Exclude from Report Candidates checkbox is not marked as checked.
- If multiple licenses exist matching this criteria, then Earliest award date license is considered.
- If multiple licenses still exist matching this criteria, then the license with the lowest internal sequence number is considered.
- The Literature book-in using the existing functionality shall not be changed.
- Additionally, for the Research report cases (3-10 in above table) have the
following data populated:
- Description as Reported=”No Events”
- Case Seriousness=”Unknown”
- The Reporting Category in PMDA tab=item selected in the assessment result dropdown.
モニタリングチェック票の印刷 (Print Monitoring Check Report)
When you click on the モニタリングチェック票の印刷 (Print Monitoring Check Report) option, the Monitoring Check Report is printed in PDF format.
For more information, see the Print Monitoring Check report section.
複数不要評価の処理 (multiple processing of Not-Necessary Assessment)
When you click this option, you can perform multiple processing of the Not necessary assessment result items. When this is selected, the system checks if all the selected items have the Not Necessary assessment results, and if these are all Not necessary, then all the selected items are moved to the Processed tab. If there are other assessment results, or if the assessment is not performed yet, then the following error message is displayed: 不要”以外の評価が存在します。”不要”の評価を持つものだけを選択してください (There are assessments other than “Not Necessary”. Please select only the data that have “Not Necessary” assessment results.)
Parent topic: Processing tab field descriptions