CLRES 2800 - FUNDAMENTALS IN CLINICAL TRIALS

Minimum Credits: 1
Maximum Credits: 1
Fundamentals in clinical trials course will provide information on the first three phases (phases i-iii) of drug development and fundamental components of randomized clinical trials. A majority of lectures will focus on aspects of phase iii parallel group designs with discussions on topics including developing research questions and defining endpoints, recruitment, randomization, blinding, data management and quality, monitoring, study closeout, and presentation/interpretation of results. The student will be introduced to the good clinical practice guidelines and the principles of planning and implementing clinical research protocols including: ethical issues and regulatory imperatives designed to protect human subjects in clinical research, adverse event reporting, protocol/proposal development, and publications. We will use manuscripts on clinical trials and protocols of completed studies to facilitate learning of concepts discussed in class. It is highly recommended that you have taken ANOVA and logistic regression courses before taking this course.
Academic Career: Graduate
Course Component: Lecture
Grade Component: Grad LG/SNC Basis
Course Requirements: CREQ: [CLRES 2005 and (CLRES 2020 or BIOST 2041)] or [MEDEDU 2005 and (MEDEDU 2020 or BIOST 2041)]; PLAN: Medical Education (ACM, MS), Clinical Research (ACM, MS), or Clinical Translational Science (PHD)

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