IND & IDE Support

Our experienced IND and IDE Support (IIS) staff provide assistance to Investigator-Sponsors and their study teams in preparing, submitting, and maintaining applications to the Food and Drug Administration (FDA) in the conduct of FDA-regulated clinical trials.

Once studies are FDA and IRB approved, the ECS-HSR Division may provide local monitoring services by assigning a lead Education and Compliance Support (ECS) Coordinator to assist with fulfilling the sponsor’s requirement to monitor the progress of the clinical investigation(s). 

Two researchers inspect a vial.

Where to Begin

Not every clinical trial involving a drug or device must be conducted under an Investigational New Drug (IND)/Investigational Device Exemption (IDE) Application. Unsure if your clinical trial must be
regulated under FDA oversight? Please read the FDA guidance and reach out to our team if you have questions.

FDA Forms

Access specific forms required for FDA-regulated clinical trials and expanded-access requests along with the instructions for completion. The forms link directly to the FDA website to ensure the most recent versions are always available. 

IND Templates

Access IND templates in support of complex regulatory and scientific work.

IDE Templates

Access IDE templates in support of complex regulatory and scientific work.

Expanded Access (Drugs)

Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient rather than to obtain the kind of information about the drug that is generally derived from clinical trials.

Compassionate Use (Devices)

Compassionate use is a potential pathway for patients with a serious or life-threatening disease or condition to access an investigational medical device that has not been approved or cleared by the FDA for treatment outside of clinical trials and no comparable or satisfactory alternative therapy options exist.