Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Cara Alfaro, PharmD
Senior Pharmacologist
Good Clinical Practice Assessment Branch (GCPAB)
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Alfaro serves as a clinical reviewer in the Good Clinical Practice Assessment Branch in the Office of Scientific Investigations. She works closely with the Office of Inspections and Investigations (OII) to assess data integrity and human subject protections through bioresearch monitoring inspections of selected clinical investigator sites, sponsors, and contract research organizations for NDAs and BLAs submitted to the Division of Neurology.
Prior to joining OSI, Dr. Alfaro was a clinical reviewer in the Division of Psychiatry at FDA. Prior to joining FDA, she was a clinical pharmacy specialist at NIMH and a member of the NIMH IRB. Dr. Alfaro attended Purdue University for her B.S. in Pharmacy and The Ohio State University for her Pharm.D. Dr. Alfaro completed both a residency and fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio.
Abstract
Cara Alfaro presents on the FDA’s Good Clinical Practice (GCP) Compliance Review, outlining the BioResearch Monitoring Program’s role in safeguarding human research participants, ensuring data integrity, and verifying regulatory adherence across over 1500 annual inspections. She explains that the Office of Scientific Investigations (OSI) coordinates these efforts, particularly focusing on GCP inspections for new drug and biologic license applications. GCP, consistent with ICH E6(R3) principles, sets the standard for trial conduct to ensure reliable data and participant protection. While not mandatory, inspections are frequently requested by review divisions for new products, efficacy supplements, or in response to issues like major protocol deviations or serious adverse events. Alfaro details the risk-based site selection process, which uses a tool ranking sites by attributes like enrollment and protocol deviations, further refined by granular analysis and statistical review. During inspections, the Office of Inspections and Investigations (OII) verifies adherence to protocols, federal regulations, and data integrity, with a focus on primary/secondary efficacy data and adverse event reporting. OSI communicates findings in real-time to review divisions, impacting ongoing analyses and potentially leading to additional inspections. Alfaro concludes by discussing inspection classifications (No Action Indicated, Voluntary Action Indicated, Official Action Indicated) and shares a case example highlighting how non-contemporaneous data entry and shared login credentials compromise data reliability, underscoring the critical need for contemporaneous data entry and proper data attribution.