The Management of Clinical Trials

GMS CI 631

This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with an explanation and analysis of selected portions of the Code of Federal Regulations (CFR), applicable to clinical research during the new drug development process. The case study approach is used in this course since the drug development industry translates these regulations into both written and unwritten standards, practices, and guidelines. Each session will use activities to expand the interpretation of the regulations, into an operational and organizational focus, further integrating real-life issues into the classroom. In order to ensure that classroom learning is linked with the students' work experiences, there will be an outside project required which will incorporate the course work with the simulated on-the-job situations, and a final presentation to share the learning with the entire class. 4 cr, Spring sem.

SPRG 2022 Schedule

Section Instructor Location Schedule Notes
A1 Volpe INS 213 M 6:00 pm-8:50 pm room requested
L213 at BUMC
MED Campus

Note that this information may change at any time. Please visit the Student Link for the most up-to-date course information.