Audit Readiness for CRAs

This presentation provides an overview of audit readiness principles tailored for Clinical Research Associates (CRAs) and their managers (administrative and operational). It focuses on equipping CRAs with the knowledge and practical tools needed to prepare for and successfully navigate audits and inspections.
Key areas include understanding regulatory expectations, maintaining high-quality and inspection-ready documentation, ensuring compliance with ICH GCP principles, and effectively supporting sites before, during, and after audits. The session also highlights common audit findings and best practices to mitigate risks and ensure consistent quality across clinical trial activities.
For CRA managers, the session additionally emphasises their role in oversight, team readiness, and fostering a quality culture.
The ultimate objective is to strengthen CRA confidence and capability in maintaining continuous audit readiness and contributing to a culture of compliance and quality.