The FDA has announced the opening of registration for its third annual FDA Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration's (FDA) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI). The course will be held on November 7-9, 2011 in Silver Spring, Maryland. Topics to be discussed include the design, conduct, and analysis of clinical trials; regulatory considerations essential for clinical research; the role of the Data and Safety Monitoring Board and Institutional Review Board in clinical studies; preclinical and pharmacological issues in clinical studies; safety assessment during clinical trials; inclusion of special populations such as pregnant women in clinical studies; and the role of personalized medicine in the future of medical product development. The course has been designed with the goal of enabling investigators to improve the quality of clinical trials and to enhance the safety of trial participants.