Fabrizio Fazzi
This course introduces you to the process and procedures of monitoring a clinical trial as a clinical research associate working for a pharmaceutical or device manufacturer (the sponsor). The course is focused on trials conducted under U.S. FDA applications (INDs and IDEs). The monitoring process begins with creating a risk-based monitoring plan. It progresses through selecting qualified investigators, executing the assessments defined in the monitoring plan, changing the plan and actions when problems and issues are identified, and closing the sites as their study participation concludes. Sponsors follow Standard Operating Procedures for monitoring clinical trials, which are based on the FDA regulations as found in 21 CFR, Parts 11,50, 54, 56, 312, and 812 and in guidance documents, such as the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) E6 and Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.
Skills / Knowledge
- Describe the process of monitoring a clinical trial, from risk analysis and monitoring plan through closing the clinical sites
- List tools and standard documents used for managing the monitoring of a clinical trial
- Apply routine monitoring techniques to evaluate compliance with a protocol and Good Clinical Practice (GCP)
- Prepare documentation following monitoring activities
- Evaluate the adequacy of critical documents throughout the process of monitoring a clinical trial
Issued on
January 30, 2025
Expires on
Does not expire