Module 3- Fundamentals of Clinical Research Site Management
The purpose of this module is to introduce you to the process and procedures of monitoring a clinical trial as a clinical research associate working for a pharmaceutical or device manufacturer (known as the sponsor) in the following outlines:
1. Focuses on trials conducted under U.S. FDA applications (INDs and IDEs).
2. The process of monitoring begins with creating a risk-based monitoring plan and 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.
3. 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, E8, E9
4. Purpose, processes, and management of protocol compliance /non-compliance
5. Roles of various clinical trial entities/plans (e.g. Medical monitor, Vendors, IRR/IEC, Sponsor, CRO) as guided by different parts of 21 CRF and GCP E6, E8, E9
6. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.
7. Communication Documentation requirements (e.g. email, phone)
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