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ICSR Check Report Validation Error for ICH R3 Profile for C.5.4 Data Element Even Though Observe Study Type Selected is Correct (Doc ID 2855152.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

ICSR check report validation error for ICH R3 profile for C.5.4 data element even though Observe Study Type selected is correct.

Steps to reproduce:
1) Create a study case with Observe Studys Type = Clinical Trial, E2B Code = 2
2) Enter all necessary information into the case for R3 reporting
3) Schedule a E2B R3 report to a reporting destination which is confifured with ICH-ICSR V3.0 MESSAGE TEMPLATE message profile
4) Generate report
5) The following validation error is received for C.5.4 data element

Value of element tag [OBSERVESTUDYTYPE] does not satisfy the condition [EVPM - For Post Marketing Report, observestudytype must be 2 or 3. EVCT - For Clinical Trial Report, observestudytype must be 1]



Cause

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In this Document
Symptoms
Cause
Solution
References


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