J2.13 Elements are Not Generated on ICSR when License is Not Specified at Study Product (Doc ID 2681757.1)

Last updated on JANUARY 01, 2025

Applies to:

Symptoms

When Console Study does not have License specified (blank) for its Study Product;

1. ICSR R3 report is generated without whole J2.13 elements even if console study has corresponding J2.13 elements values.
2. The same Validation Report is not generated by the same condition as when study product license is being specified at console study.

Steps to Repeat:

1. Set OOTB PMDA R3 ESM Profile for a Reporting Destination code list of PMDA agency.
2. Create a new study on Argus Console. On J Data Entry dialog, enter values for all J2.13 elements and leave the license field of study product blank.
3. Create a new study case by the console study.
4. Enter data for the case and schedule PMDA R3 E2B report.
5. Click Draft link of the PMDA R3 E2B report. I.C.S.R Viewer opens but whole J2.13 elements are missing. --- Issue#1
6. On Argus Console, remove value of J2.13.r.4 (at 'Are any subjects given this investigational drug?' field) and fill values for all the rest J2.13.r.X elements for the Console Study.
7. Click Draft link of the PMDA R3 E2B report. Validation Report is not generated but I.C.S.R Viewer opens with whole J2.13 elements are missing. --- Issue#2   At the same condition, Validation Report is generated when study product license is being specified at the console study.

Cause

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