On completion of this seminar you will have an awareness of the audit process of a clinical trial. You will appreciate the role of the auditor/ auditee in an audit. You will have a clear understanding of how to prepare for a clinical trial audit, and how to participate effectively as an interviewee in an audit meeting. You will be familiar with the notions of corrective and preventive action, root cause analysis, categorization and reporting, findings, corrective action tracking and follow-up.
- Purpose of audits in clinical trials
- Types of audits in clinical trials
- Preparing for audits
- Logistics (meeting room booking, arranging interviews etc.)
- Key risk areas for audita
- Thinking model to achieve success at audits
- Requirements for a qualified auditor
- Personal attributes
- Training and certification
- Probing skill set for auditors
- Presenting and escalating audit findings
- Post-audit follow-up actions
- CAPA and root cause analysis
Preparing for Audits
Besides considering the essential documents and logistics arrangements, the program will introduce the “hidden risk map” in clinical trials. Through the discussion of scenarios, participants will learn to pay more attention to the hidden risks in the everyday conduct of clinical trials.
Thinking Model to Achieve Success at Audits
Not all participants will play the role of an Auditor, however, learning to THINK like an Auditor can benefit everyone and enable site staff to manage trial quality by themselves. The Thinking Model contains six practical steps. Through interactive scenario and hands-on practice, participants will be able to manage audit plans, audit reports and corrective and preventative action plans.
By asking the right questions, an auditor can influence the way people think and behave. Participants will be able to understand the question types and probing skills used in audits, and discover how active listening can support fact finding. Through a simulation session, participants can acquire these questioning skills and discover the hidden risks that can result from organizing Information poorly.
Post Audit Action
Knowing how to present and escalate audit findings is critical for continuous improvement actions at a study site. Examples of audit finding reports and interactive exercises will help participants to facilitate improvement action with the study teams at their own sites.