ComplianceOnline

Clinical Trial Audits


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

The sponsor's audit plan and procedures for a trial audit should be guided by:

  • The importance of the trial to submissions to regulatory authorities
  • The number of subjects in the trial
  • The type and complexity of the trial
  • The level of risks to the trial subjects
  • Any identified problem
Purpose of Clinical Trial Audits

A clinical trial audit is meant to ensure:

  • Protection of subjects enrolled in clinical trials;
  • Increase confidence that the data collected and subsequently submitted is valid;
  • Verify compliance with regulations which includes the principles of Good Clinical Practices (GCPs).
The most cited clinical trial areas during audits

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
ComplianceOnline training on clinical trial audits

Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
This Clinical trial auditing training provides an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.