Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Adarsh Daswani, a clinical investigator, failed to conduct a clinical investigation of an investigational drug in accordance with the approved investigational plan, violating 21 CFR 312.60. Specifically, he did not ensure that randomized treatment was properly administered, randomized dose adjustments were made by the Interactive Response Technology (IRT) system as required, and protocol-specified procedures were followed when hemoglobin concentration measurements met specified thresholds. The violations were identified during an FDA Bioresearch Monitoring Program inspection conducted in October 2021, which focuses on ensuring the rights, safety, and welfare of human subjects in clinical research.