Joint Clinical Trials Office

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Writing an Investigator Initiated Trial (IIT)

This section is in development. The JCTO will provide guidance on submitting Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE). For more information on INDs and IDEs visit the Food and Drug Administration website pages listed below.

21 CFR Part 312: IND

21 CFR Part 812: IDE

A template has been developed outlining the important components of an investigator initiated trial protocol. 

Researcher's Toolbox

Contact Information

Joint Clinical Trials Office Weill Cornell Medicine /
NewYork-Presbyterian
1300 York Avenue,
Box 305
New York, NY 10065 Phone: (646) 962-8215 Fax: (646) 962-0536

Abbreviation Library