The following areas are most cited for non-compliance during clinical trial audits:
- Informed Consent Process & Documentation
- Accurate and Complete Study Records
- Determination and Documentation that eligibility criteria are satisfied
- Adverse Event review and reporting
- Closure of study or lapse in approvals while study related activities are still ongoing.
- Drug/Device accountability
- Protocol adherence
- Poor regulatory site documentation
- Failure to address monitor findings.
