Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Evelyn Lopez-Brignoni, a clinical investigator, failed to conduct drug clinical investigations in accordance with their investigational plans as required under 21 CFR 312.60. Specifically, during FDA's inspection of her clinical site in June 2020, investigators found that she did not ensure subjects received the correct dosing regimens specified in the study protocols, including failures to maintain adequate blinding by not providing all subjects with the required amount of study medication per dose as outlined in the informed consent forms. These deviations from the approved investigational plans violated fundamental requirements for protecting human subject safety and study integrity in clinical drug trials.