Printing Gk22/Gk23r1 as Blinded for Non-Blinded Study Products in PMDA E2B R3 Paper Report in Argus Safety Japan
(Doc ID 2418079.1)
Last updated on MAY 26, 2021
Applies to:Oracle Argus Safety - Version 8.1.2 to 8.1.2 [Release 8.1]
Oracle Argus Safety Japan - Version 8.1.2 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.
Configure a study with these products:
- a CDD drug with "Blinded" checkbox checked (e.g., main IMP)
- a CDD drug with "Blinded" checkbox checked (e.g., placebo)
- a CDD drug with "Blinded" checkbox is NOT checked (e.g., OXALIPLATIN)
Book in a case for the study.
Two product tabs are automatically created; one for the blinded part and one for the non-blinded product. For example:
Enter all the required data for the non-blinded products in the case.
Schedule and generate a PMDA E2B R3 paper form with 'Do you want to hide unblinded information?' = Y
In the Product sections of the report, G.k.2.2 MEDICINALPRODUCT and G.k.2.3.r.1 ACTIVESUBSTANCENAME appear as blinded for the non-blinded study products configured above:
The problem also occurs for any non-blinded products added in the Case Form > Products tab.
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