Pharmaceutical Clinical Trial Management Audit Checklist

Clinical trial audits should be conducted at key milestones of the trial, such as after first patient enrollment, mid-study, and before database lock. For long-term studies, annual audits are recommended.

This checklist covers protocol compliance, informed consent processes, investigator qualifications, site management, data collection and handling, adverse event reporting, drug accountability, and essential document maintenance.

These audits are typically conducted by clinical quality assurance specialists, independent auditors, or clinical research associates with expertise in GCP and regulatory requirements for clinical trials.

The checklist ensures that all aspects of clinical trial management adhere to GCP guidelines and regulatory standards, including patient protection, data integrity, and proper documentation, which are crucial for regulatory submissions and approvals.

If significant protocol deviations are identified, actions should include immediate notification of the sponsor and ethics committee, thorough investigation of the impact on patient safety and data integrity, implementation of corrective measures, potential protocol amendments, and enhanced monitoring. All actions must be meticulously documented.