Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Angela M. Stupi, a clinical investigator in Pennsylvania, failed to conduct investigational drug studies in accordance with approved protocols during FDA's September 2022 inspection. Specifically, she did not properly verify that study subjects met the required inclusion and exclusion criteria before enrollment and failed to administer study drugs at the specific body locations designated in the protocols. These violations of 21 CFR 312.60 undermined the integrity of the clinical investigations and the protection of human subjects participating in the studies.