Good Clinical Practice E6 (R3) Practice Test

Audit findings are signals that something in the trial process isn’t meeting requirements, so the right approach is to document each finding, assess its impact, and implement corrective and preventive actions with a clear timeline, then verify that those actions fixed the issue before closing the finding. This creates a traceable record, supports regulatory compliance, and drives continual improvement and participant safety. Leaving findings unaddressed, keeping them secret, or restricting their distribution prevents timely action and weakens the quality system. Involving the appropriate stakeholders ensures root causes are addressed, actions are implemented, and effectiveness is later confirmed.