Navigating Clinical Trials: Essential Knowledge for Dermatologists-Preparing for Audits and Inspections

Video Transcription

Video Summary

Dr. Robert Bissonnette, a dermatologist from Montreal with 30 years of experience in clinical research, differentiates between audits and inspections in clinical trials. Audits, typically conducted by sponsors or clinical research organizations (CROs), assess compliance with regulations and procedures, focusing on high-enrollment sites prone to protocol deviations. Inspections, by contrast, are conducted by regulatory bodies like the FDA to ensure data integrity and safety, often responding to complaints or serious protocol breaches. Bissonnette emphasizes readiness for inspections: maintaining up-to-date documentation, communicating with sponsors, and preparing staff. He advises conducting mock inspections and familiarizing oneself with regulatory policies. Interacting with inspectors involves being polite, honest, and concise. Post-inspection outcomes range from no action indicated to potential enforcement actions like study termination. Bissonnette underscores the importance of quality documentation, involving experienced coordinators, and ensuring thorough evidence of sponsor decisions in maintaining inspection readiness.

Asset Subtitle

by Robert Bissonnette, MD, MSc, FAAD

Keywords

clinical trials

audits

inspections

regulatory compliance

data integrity

inspection readiness