FDA Clinical Investigator Training Course

Clinical investigators play a pivotal role in medical product development by providing FDA with the clinical data for regulatory decisions. Yet, the clinical trial industry faces a chronic shortage of well-trained, experienced clinical investigators committed to performing clinical trials over the long haul.

The resultant need to continually recruit new investigators drains valuable resources and may compromise the quality of clinical research, since new investigators may be less equipped to recognize emerging safety issues, ethical problems, and pitfalls in study design. They may also not fully apprehend FDA's regulatory and monitoring requirements.

To help develop a cadre of well-trained investigators, FDA's Critical Path Initiative has launched a Clinical Investigator Training Course targeted at medical professionals (experts who sign FDA Form 1572 before participating in an investigation). The 3-day course includes lectures given by senior FDA experts and guest lecturers from industry and academia, providing FDA's perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research, and acceptable scientific and analytic standards in clinical study design and conduct.

The annual courses, held in November 2009 and 2010, quickly filled to capacity, drawing 125 participants from across the United States and from as far away as Japan, Mali, Egypt, and Taiwan. The course covered topics ranging from basic concepts of clinical trial design and how to review clinical data for sources of bias and errors to what to look for in drugs being studied in a clinical trial.

To access FDA course materials, please follow the link below:
FDA's Clinical Investigator Training Course