The Office of Compliance provides educational resources for the Emory research community. Training regarding FDA regulations and sponsor-investigator (S-I) responsibilities is provided individually and through educational presentations to investigators and research study staff.
Below are materials that have been presented in previous educational presentations.
- Charging for Investigational Drugs in Clinical Trial and in Expanded Access
- Dietary Supplements and IND
- Humanitarian Use Device and Humanitarian Device Exemption
- Institutional Review Board Responsibilities in Making the Significant Risk and Non-Significant Risk Device Determination
- Investigator Device Exemption (IDE) Overview
- Sponsor-Investigator Drug Safety Reporting
- Sponsor/Investigator Responsibilities
If you have any questions or would like to discuss topics related to FDA regulated studies, please contact us at (404) 727-2398 or email@example.com.