J2.4.K Error For Study INV License ICSR Report On Foreign Non-Blinded Study Case

(Doc ID 2352228.1)

Last updated on MAY 25, 2018

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.

Symptoms

ICSR report is unable to be opened by clicking Draft link with ICSR Validation J2.4.k error on a foreign non-blinded study case.

ICSR report is able to be opened if the case is having only study product.
However, if the case has additional case product with MKT license than the study product, the same ICSR report scheduled for the study product becomes unable to be opened.
ICSR report for additional case product MKT license is able to be opened if the Draft link of that MKT license is clicked first.

Once J2.4.k error appears on ICSR Validation Report by clicking Draft link of one of report, the same J.2.4.k error appears for the other report.
If Draft link of report for INV license is clicked first, J2.4.k for Investigational Reports error appears on ICSR Validation Report, then the same J2.4.k for Investigational Reports error appears for MKT license report.
If Draft link of report for MKT license is clicked first, ICSR Viewer opens for MKT license report, but J2.4.k for Marketed Reports error appears on ICSR Validation Report for INV license report.

 

Error on ICSR Validation Report:
-----------------------------------------

Other Fatal Validation
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
Case Form/Analysis/PMDA/General/Category of New Drug
Value of J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] shall belong to either 1,2,5,6 or 7 for Marketed Reports (Reporting category AA, AB, AC, AD, AE, AF, AG).
その他の致命的な検証
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
症例フォーム / 解析 / PMDA情報 / 一般 / 被疑薬ライセンスの情報 / 新医薬品等の区分
J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS]の値は、市販後報告の1、2、5、6または7 (報告分類AA、AB、AC、AD、AE、AF、AG)のいずれかに属する必要があります

or

Other Fatal Validation
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
Case Form/Analysis/PMDA/General/Category of New Drug
Value of J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] shall belong to either 3 or 4 for Investigational Reports (Reporting category DA, DB, DC, DD, DE, DF, DG).
その他の致命的な検証
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
症例フォーム / 解析 / PMDA情報 / 一般 / 被疑薬ライセンスの情報 / 新医薬品等の区分
J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS]の値は、治験報告の3または4 (報告分類DA、DB、DC、DD、DE、DF、DG)のいずれかに属する必要があります

 

HOW TO REPEAT:
----------------------
1)
Create Products and Study on Argus Console.

Product-A
...|--Japanese MKT drug license
...|--Japanese INV drug license

Product-B
...|--Japanese MKT drug license

Study-A
...|--Study Type = Non Blinded
...|--Products = Product-A

2)
Create a new foreign study case by Study-A.

3)
Enter data to the case for E2B report.
On Case Form >> Analysis >> PMDA Info >> General;
...|--MKT drug License of Study Product:
......|--License Category = Within 2 years after approval
......|--Reporting Category = D Case reports on adverse drug reactions in foreign countries (post-marketing)
...|--INV drug License of Study Product:
......|--License Category = Unapproved
......|--Reporting Category = K Case reports on adverse drug reactions in foreign countries (clinical trial)

On 症例フォーム >> 分析 >> PMDA情報 >> 一般;
...|--被疑薬ライセンスの情報 - MKT drug License:
......|--新医薬品等の区分 = 承認2年以内
......|--報告分類 = D-外国副作用症例報告(市販後)
...|--被疑薬ライセンスの情報 - INV drug License:
......|--新医薬品等の区分 = 未承認
......|--報告分類 = K-外国副作用症例報告(治験)

4)
Schedule E2B R3 report for PMDA agency for Study INV drug license.

5)
Click Draft link of E2B R3 report for PMDA agency for Study INV drug license.
--->
E2B Viewer successfully opens.

6)
Add Product-B to the case on Case Form >> Products.

7)
Enter data to the case for the added product for E2B report.
On Case Form >> Analysis >> PMDA Info >> General;
...|--MKT drug License of added Product:
......|--License Category = Not applicable
......|--Reporting Category = D Case reports on adverse drug reactions in foreign countries (post-marketing)

On 症例フォーム >> 分析 >> PMDA情報 >> 一般;
...|--被疑薬ライセンスの情報 - MKT drug License:
......|--新医薬品等の区分 = 該当なし
......|--報告分類 = D-外国副作用症例報告(市販後)

8)
Go to Case Form >> Regulatory Reports.
Only 1 report schedule exists for E2B R3 report for PMDA agency for Study INV drug license.

9)
Click Draft link of E2B R3 report for PMDA agency for Study INV drug license.
--->
ICSR Validation Report opens.

Other Fatal Validation
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
Case Form/Analysis/PMDA/General/Category of New Drug
Value of J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] shall belong to either 3 or 4 for Investigational Reports (Reporting category DA, DB, DC, DD, DE, DF, DG).

10)
Schedule E2B R3 report for PMDA agency for Product-B MKT drug license.

11)
Click Draft link of E2B R3 report for PMDA agency for Study INV drug license.
--->
ICSR Validation Report opens.

Other Fatal Validation
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
Case Form/Analysis/PMDA/General/Category of New Drug
Value of J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] shall belong to either 3 or 4 for Investigational Reports (Reporting category DA, DB, DC, DD, DE, DF, DG).

12)
Log out from Argus Safety, clear cache of IE of client PC, and Log in to Argus Safety again.

13)
Open the same case and go to Case Form >> Regulatory Reports.

14)
Click Draft link of E2B R3 report for PMDA agency for MKT drug license.
--->
ICSR Viewer successfully opens.

15)
Click Draft link of E2B R3 report for PMDA agency for Study INV drug license.
--->
ICSR Validation Report opens.

Other Fatal Validation
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
Case Form/Analysis/PMDA/General/Category of New Drug
Value of J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] shall belong to either 1,2,5,6 or 7 for Marketed Reports (Reporting category AA, AB, AC, AD, AE, AF, AG).

 

 

Cause

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