Trial Master File audit (TMF, paper and electronic): checking TMF set-up, management, TMF content and inspection readiness at different study timepoints and after trial completion.
Monitoring process audit: review of monitoring activities related to one study or across multiple studies to check compliance with study protocol, monitoring plan, and ICH-GCP Guidelines.
Project management audit: checking aspects of project management services and documents to ensure compliance with legal and contractual requirements.
Study start-up audit: check of submission and approval process, site activation and related documents for compliance with local and international regulations.
Clinical trial document audits include review of different documents generated for clinical trial conduct: Study Protocol, Investigator Brochure, Informed Consent Forms, Clinical Study Report, etc.