According to ICH E6, what does an inspection typically involve?

An inspection, according to ICH E6 guidelines, typically involves a systematic and independent examination of trial-related activities and documents. This process is crucial for ensuring the integrity of clinical trials and compliance with Good Clinical Practice (GCP) standards. Inspections are designed to verify that the conduct of the clinical trial adheres to the protocols, regulations, and procedures put in place, ensuring that data quality and participant safety are maintained throughout the study.

During such inspections, regulatory authorities or independent inspectors will assess various aspects, including the trial site’s adherence to Good Clinical Practice, the accuracy and completeness of trial documentation, and the overall management of the study. By focusing on a thorough examination of these elements, the inspection serves to foster transparency and accountability within clinical research, ultimately supporting the reliability of the trial results and the protection of human subjects involved in the research.