Too many principal investigators (PIs) don’t realize “the buck stops with them” in many cases if there are problems during a clinical trial, says Glenda Guest, CCRA, RQAP-GCP, TIACR, FACRP, ACRP-MDP, president of Assured Quality Consulting & Training. A Warning Letter from the U.S. Food and Drug Administration (FDA) or any other communication about an infraction of the regulations “is going to have the PI’s name on it,” she notes.
During times of stress and trouble, fingers are often pointed at the clinical research coordinator (CRC) or other “feet on the ground” personnel during clinical trial operations, Guest explains. However, it’s the PI who’s generally the person regulators will focus on during an inspection or other interaction, she says.
Further, the rise of decentralized clinical trials (DCTs) is only making oversight of PIs more critical, Guest adds. As trial operations spread and become more remote, the role of the PI as a center of gravity becomes increasingly vital, she says.
FDA Inspections: Understand the Process and Manage the Consequences
Join Guest and Holwell at ACRP 2022 for this interactive exploration of FDA inspections. This session will cover important GCP topics and preparation for audits and regulatory inspections to help you feel confident in managing inspections.
“DCTs are here to stay,” adds Janet Holwell, CCRC, CCRA, TIACR, FACRP, a clinical research consultant/trainer. “PI oversight is even more important now,” she emphasizes, pointing out how recent FDA Warning Letters have also highlighted the importance the agency places on PIs properly disclosing any financial relationships they have with their trials. Honest and accurate financial disclosure is very important, she says.
Holwell and Guest are also fans of reading FDA Warning Letters and 483s (Inspection Observations) to help practitioners of today learn from the past. “FDA is clear about what constitutes an adequate or inadequate response,” notes Guest. “It’s critical to helping better understand the FDA’s expectations, and then to meet them,” she says.
Author: Michael Causey