Course Description: Fundamentals of Clinical Research, an interactive program providing online and classroom training for the clinical research professional, begins with the history of legislation and regulations that govern clinical research and an overview of drug, biologic, and device development. Course participants develop a thorough knowledge base of Good Clinical Practices and International Conference of Harmonization guidelines (E6, E2A), gaining a solid understanding of clinical trial development and management.
The Part 2 classroom training focuses on developing a systematic approach to monitoring, conflict resolution, and problem solving. The participants monitor 6 study subjects and 3 regulatory binders across two study types. Writing effective and professional monitoring reports is also addressed. During the review and discussion of GCP issues, the instructor highlights the differences between device and drug/biologic studies.
"Fundamentals of Clinical Research" is one of the only known courses that offer ALL the following:
- Extensive clinical research education, including device and drugs/biologic regulations
- "Hands-on" training for CRAs and related professions
- Assistance with resume preparation