What does the term "audit" refer to in the context of ICH E6?

The term "audit" in the context of ICH E6 refers to a systematic and independent examination of trial activities. Audits are critical in clinical research as they help ensure that the trial is conducted according to the protocol, applicable regulations, and Good Clinical Practice (GCP) guidelines. They assess compliance and the integrity of the data collected, which is essential for validating the results of the trial.

This process is rigorous and methodical, often involving a review of documentation, interviews with team members, and assessments of trial procedures. The goal is to identify any discrepancies or areas for improvement in the conduct of the trial and to ensure that the rights, safety, and well-being of trial participants are protected.

Understanding this definition emphasizes the importance of audits in maintaining the quality and reliability of clinical research, which is paramount for regulatory approvals and ultimately for patient safety and treatment efficacy.