Managing non-compliance is critical to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, correct the non-compliance through intervention, and evaluate the effectiveness of the intervention. Root cause analysis (RCA) provides a process through which issues can be accurately identified and interventions can be effectively designed and therefore an effective Corrective and Preventive Action (CAPA) process can lead to improved protections for participants and confidence in the integrity of the data. This session will look at RCA/CAPA principles and apply these to several clinical trial case studies.
Chairperson: Katrina Harrison, Novotech