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Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
April 27, 2018 @ 10:00 am - 11:30 am
4/27/2018 at 10:00 AM – 11:30 AM (EST) Reed Hall – B102 Reed Hall (OHSR Conf Rm) Baltimore, MD
Institutions, sponsors, and the NIH are increasingly requiring good Clinical Practice or ‘GCP’ training for investigators and study-team members. This 90-minute course will explain the elements of the International Conference for Harmonization’s (ICH) principles and specific guidelines for Good Clinical Practice. Attendees will be introduced to the GCP Principles, and will explore investigator responsibilities in human subject research, focusing on the areas of trial conduct (experience, resources, and physician duties); performance (communication with the IRB, protocol compliance, and investigational product management); ethical research (safety oversight and informed consent); and recording/reporting (data acquisition, progress summaries, and safety-event reporting). **PI recertification approved**