This course will introduce research support staff to:

1. The difference between monitoring, auditing and inspection
2. The role of monitors (CRAs) in clinical trials
3. Different monitoring approaches in a clinical trial
4. The auditing process and its relation to the quality management of a clinical trial
5. Concepts of root cause analysis and corrective and preventive actions for trials audit/inspection findings
6. Guiding tools and checklists to prepare for site audit/inspection visits