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CRC160: Clinical Research Site Management – 4 credits

Clinical research site organization, operation and management. Office setup, study initiation process, site maintenance, essential documentation requirements and binders, site evaluation and site closure. Understanding Institutional Review Boards (IRB) timeliness for submission, approval and study maintenance. Budget and contract negotiation, and sponsor and regulatory audit components and preparation. Coordination with sponsors and related research entities; investigative staff training. Organization of process flow and effective interactions with IRB, Contract Research Organizations, sponsors, regulators, investigators, and community. Prerequisites: None.