The recent addendum to ICH E6(R1) - Guideline for GCP E6(R2) places a strong emphasis on quality management within clinical trials (ICH GCP 5.0) and the expectation now is for sponsors to perform root cause analysis and implement appropriate corrective and preventive actions (ICH GCP 5.20.1) to manage noncompliance. Root Cause Analysis provides a process through which issues can be accurately identified and interventions can be effectively designed, implemented and monitored for effectiveness.
This 2-day workshop will provide delegates with the various tools used to conduct root cause analysis and understand how to develop an effective CAPA process to ensure subject protections and data integrity is maintained in a clinical trial. Writing a good CAPA is critical to this process and delegates will learn how to develop and document a good CAPA. This workshop will focus specifically on the management of noncompliance issues occurring at investigative sites.