CTA 5300 - Clinical Study Administration I

This course covers the planning, development, implementation and management of clinical trials. Topics include regulations, protocol development, case report form design, clinical data management operation, writing and conducting informed consent, Institutional Review Boards, contracting, budget development, selection and evaluation of research sites and activities required for implementation of a clinical trial.

Prerequisites/Corequisites: Prerequisite: CTA 5000.

Credits: 3 hrs.