Regulatory is the day-to-day management of policy and support provided to ensure that clinical trials are appropriately evaluated, investigated and submitted.
Roles and Responsibilities
- Obtaining a copy all investigators and coordinators licenses, human subjects training, HIPAA, picture identification and NIH biosketches
- Maintaining all regulatory documents for each clinical trial. A completed CRC application is needed for all trials utilizing the CRC or its resources.
- Maintaining a record of Adverse Events, Serious Adverse Events and other safety information as required by institutional, sponsor, NIH or federal guidelines
- Dispersing a variety of information associated with clinical protocols and the daily operations of clinical trials
- Serving as a liaison to MSM Institutional Review Board (IRB) and Grady Research Oversight Committee (ROC) as well as assisting in the preparation of materials to be submitted
Click here for link to register in IRB Net
Morehouse School of Medicine
Clinical Research Center
720 Westview Drive, S.W.
Atlanta, Georgia 30310
Phone: (404) 756-5022