New drug or new device studies (IND/IDE)

According to the FDA: Applicable clinical trials generally include controlled interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE). Trial sponsors and investigators have the responsibility of determining whether or not a trial is an "applicable clinical trial."

For drugs, phase 1 clinical investigations (defined in 21 C.F.R. § 312.21) are not categorized as "applicable clinical trials."42 U.S.C. § 282(j)(1)(A)(iii). Uncontrolled clinical investigations of drugs or devices also are not considered "applicable clinical trials."

For devices, small feasibility trials and larger clinical trials of prototype devices with a primary measure of feasibility rather than health outcomes are not applicable clinical trials. 42 U.S.C. § 282(j)(1)(A)(ii). Under current guidance contained on NIH's website at , a device trial is not an applicable device clinical trial when the trial includes only de-identified human specimens and does not include "human subjects"

Additional "Guidance for Sponsors, Investigators, and Institutional Review Boards," and "Questions and Answers on Informed Consent Elements under 21CFR50.25(c)," can be found at:

All Principal Investigators acting as a "Sponsor-Investigator" (S-I) for research involving and IND or IDE are required to fulfill the mandatory CUMC training for FDA --regulated Human Subjects Research. Questions regarding the requirements should be directed to the Clinical Trials Office (CTO) at The IRB will not approve  the enrollment of subjects in S-I research until the CTO notifies the IRB that the mandated prerequisites of the IND/IDE Assistance Program have been met.


Submissions of studies involving an IND or IDE that is held by the Principal Investigator, or by another faculty member who will be acting as Sponsor-Investigator, must be submitted along with the "Form of Notice by IND/IDE Holder"€, as part of the submission, and the IND/IDE must be approved by the Department Chair.


Forms (links)

Form of Notice by IND/IDE Holder 

IDE Decision Worksheet

IND Decision Worksheet