In this scenario, a Clinical Supplies tester wrote test scripts for a blinded, randomized, titration study. Study-specific negative scenarios were not tested. The RTSM was approved by the study team, and the pediatric patients began their dosing visits. All patients immediately experienced adverse effects. Upon investigating the issue, it was discovered that the RTSM was configured incorrectly, and the error could have been detected through negative testing. This oversight was detrimental to the study.

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