140-HR CRA Certificate Program

	Part 1: Online with text-book and regulatory CD-ROM provided.
	Part 2: Two weeks hands on training with competency and regulatory exams.

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.

Payment Schedule:

	$1,995 required for Part 1; this provides the applicant with access to the online course. Course textbook and materials sent via express mail;
	$1,500 is due on, or prior to the Part 2 “Training” starting date.