EOSU: Unblinding Of Cases Where Patient Receives Two Treatment Drugs (Doc ID 1360403.1)

Last updated on SEPTEMBER 20, 2011

Applies to:

Oracle Argus Unblinding - Version: 4.2 to 7.0 - Release: 4 to 7.0
Information in this document applies to any platform.

Symptoms

Unable to unblind cases where patient has received two drugs as treatment received. The study for these cases has multiple study drugs configured.

Steps to Repeat:
(1) Create study with following study drugs:
         StudyID: EOSU Test
         Study Products: Drug A, Drug B & Placebo
(2)Create CT cases using study EOSU Test
(3) Create treatment randomization file
        - 2 treatment rows for each patient

(4) Configure EOSU Profile for EOSU Test
(5) Load Randomization file
(6) Product Mapping
         Drug A - A
         Drug B - B
         Placebo - C
(7) Dry run profile
(8) Observe the following entry in the exception report:
      "Duplicate entries in Randomization Data (Study+Rand#/Patient ID) are matching the Case Data."

Cause

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