B.4.k.2.2 Missing Error at E2B Generation after Utilities >> End Of Study (Doc ID 2227984.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

PROBLEM DESCRIPTION:
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After a study-case is unblinded by Utilities >> End Of Study, generating E2B for PMDA agency fails with the following error message on PMDA ICSR Validation Report.

Message on PMDA ICSR Validation Report:

 
This error does not occur if the study-case is unblinded by selecting unblinded value from Drop-Down list at Case Form >> General >> Blinding Status' field.

HOW TO REPEAT:
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1) Prepare a blind study and Expedited Report Rule for PMDA agency matching with the study drug on Argus Console.
2) Create a new study case with blinded study.
3) Enter data for E2B to the case. Close case form.
4) Select Utilities >> End Of Study. End-of-Study Unblinding window opens.
5) On the End-of-Study Unblinding window,
select the study of the case by drop-down list.
Cases are listed.
6) On the End-of-Study Unblinding window,
fill Drug Received field by drop-down list for the case of step-2) and 3),
then click [OK].
The End-of-Study Unblinding window closes automatically.
7) Open the case and go to Case Form >> Regulatory Reports.
Reports have been scheduled.
8) Click Draft link of E2B report for PMDA agency.
--->
PMDA ICSR Validation Report opens with error at B.4.k.2.2.

Changes

Cause

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