Investigational New Drug (IND) and Investigational Device Exemption (IDE)
The Education and Compliance Support for Human Subjects Research ECS-HSR Office at the University of Pittsburgh provides information for Investigator-Sponsors and study teams if an IND or an IDE is needed. Not every study involving a drug or device must be conducted under an IND/IDE application.
Please read ECS-HSR Guidance and email the ECS-HSR Office below, if you have any questions.
If you determine that an IND/IDE is needed, the office will assist in preparing, submitting, and maintaining applications to the Food and Drug Administration (FDA) for FDA regulated clinical trials. FDA and IRB approved studies may be provided with monitoring services from an Education and Compliance Support Coordinator to assist with your study and execute sponsor requirements.
ECS-HSR Office
