The primary objectives of GCP quality audits are to ensure that the rights of trial subjects are respected (as per the Declaration of Helsinki) and that the integrity of the trial data can be assured. Sponsors of clinical trials are expected to implement quality systems and processes with procedures that assure the quality of every aspect of the trial, and these systems and processes are subject to regular audit.
Routine audits of clinical trials can be scheduled during any phase of development and at any time during the conduct of the trial.
Scope of GCP Audits
- Investigator Site
- BE / Clinical Study CRO
- Third party service provider
- Clinical trial central pathology laboratory
- Investigational product depot/supplier
- IWRS/IVRS service provider