Support multiple projects to make clinical trials more efficient - Examples include develop, plan, and hold training for clinical investigators worldwide to improve the safety and efficiency of clinical trials; support Clinical Trials Transformation Initiative (CTTI) project to draft and issue white papers (part of large effort to improve trial management and protect the safety of participants while optimizing procedures to ensure trial quality and data acquisition).To address the clinical trial industry's chronic shortage of well-trained, experienced clinical investigators committed to performing clinical trials over the long haul, the office has launched an annual 3-day Clinical Investigator Training Course targeting medical professionals. Clinical investigators are pivotal to medical product development because they provide FDA with the clinical data required for making regulatory decisions. This training course helps to develop a cadre of well-trained investigators by ensuring that they are apprised of FDA regulatory and monitoring requirements as well as other key knowledge areas essential to conducting quality clinical research. In the November 2010 course, senior FDA experts and guest lecturers from industry and academia offered participants from across the globe FDA perspectives on such important issues as 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. Videos, slides, and transcripts are available to those investigators unable to attend the 2010 course on <a href=http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm236523.htm target=”_blank”>FDA's Critical Path Initiative website</a>.A. Issue white paper on goals and objectives of clinical trial monitoring8/1/2010Completed5/17/2010B. Announce FDA Clinical Investigator Training Course in the Federal Register9/30/2010Completed9/21/2010C. Hold Clinical Investigator Training Course11/8/2010 - 11/10/2010Completed11/8/2010 - 11/10/2010D. Expand training outreach by publishing video course online3/31/2011Completed12/5/2010http://www.fda.gov/AboutFDA/Transparency/track/ucm206688.htmFDA-TRACK OC Office of the Chief Scientist Dashboard