J2.4.K Error For MKT And INV License ICSR Reports For PMDA On Domestic Blinded Study Case (Doc ID 2350585.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

ICSR report is unable to be opened by clicking Draft link with ICSR Validation J2.4.k error on a domestic blinded study case when study has one INV license and case has additional MKT license case product.

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 MKT license is clicked first, J2.4.k for Marketed Reports appears on ICSR Validation Report, then the same J2.4.k for Marketed Reports appears for INV license report.
If Draft link of report for INV license is clicked first, J2.4.k for Investigational Reports appears on ICSR Validation Report, then the same J2.4.k for Investigational Reports appears for MKT license report.

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

or

HOW TO REPEAT:
----------------------
1)
Create Products and Study on Argus Console.
The study is double blinded study, the study has one study product, and the study product is one INV license.

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

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

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

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

3)
Add Product-B to the case on Case Form >> Products.

4)
Enter data to the case for E2B report.

On Case Form >> Analysis >> PMDA Info >> General;
...|--INV drug License of Study Product:
......|--License Category = Unapproved
......|--Reporting Category = I-Case reports on adverse drug reactions in Japan (clinical trial)
...|--MKT drug License of added Product:
......|--License Category = During early post-marketing phase vigilance
......|--Reporting Category = B-Case reports on adverse drug reactions in Japan (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 - INV drug License:
......|--新医薬品等の区分 = 未承認
......|--報告分類 = I-国内副作用症例報告(治験）
...|--被疑薬ライセンスの情報 - MKT drug License:
......|--新医薬品等の区分 = 市販直後調査中
......|--報告分類 = B-国内副作用症例報告（市販後）

5)
Schedule E2B R3 report for PMDA agency for Study INV drug license and MKT drug license.

6)
Click Draft link of E2B R3 report for PMDA agency for MKT 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).

7)
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).

8)
Log out from Argus Safety, clear cache of IE of client PC, and Log in to Argus Safety again.

9)
Open the same case and go to Case Form >> Regulatory Reports.

10)
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).

11)
Click Draft link of E2B R3 report for PMDA agency for MKT 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).

Changes

Cause

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