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

Last updated on JULY 13, 2023

Applies to:

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."

Changes

Cause

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