Last updated on JANUARY 29, 2017
Applies to:Oracle Argus Safety Japan Cloud Service - Version 7.0 and later
Information in this document applies to any platform.
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:
E2B Element = B.4.k.2.2
E2B Description = ACTIVESUBSTANCENAME
E2B Field Location = Code List / Products
E2B Field Name = Key Ingredient
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:
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.
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