A sponsor’s audit of a clinical trial is an important element of GCP and is independent of and separate from monitoring and quality control functions. Its purpose is to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
The auditor chosen by the sponsor to audit a clinical trial should be:
- Independent of the clinical trials/system
- Qualified by training and experience to conduct the audits properly and these qualifications should be documented.
