Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Anish S. Shah's clinical research site failed to conduct a drug investigation in accordance with FDA regulations governing clinical trials (21 CFR 312). The primary violation involved failure to maintain investigator blinding as required by the study protocol, specifically allowing the clinician administering efficacy assessments to have access to safety data (clinical laboratory results and vital signs) when they should have been blinded to this information. This inspection was conducted under FDA's Bioresearch Monitoring Program to verify that human subjects' rights, safety, and welfare were adequately protected during the clinical investigation.