Course Number: BIOL 537 (3.00 Units)
You will receive a comprehensive overview of the components necessary for setting up a human clinical trial. Topics include the various types of phases of clinical trials, implementation of Good Clinical Practices (GCP), development of clinical study documents, interactions with the Institutional Review Board (IRB), identification and qualification of study sites, insurance requirements and needs, statistical considerations in study design, ethical issues, setting up clinical trials globally, investigator and subject matter recruitment issues and inclusion and exclusion criteria. The course will also examine project management skills and best practices used when developing project plans, forming a clinical trial team, developing a clinical trials budget and negotiating contracts. Team projects based on case studies and real world examples will reinforce the overall course objectives.
Note: Click on the schedule number (i.e. E125-11103) to view more course information.
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