Guidance
Determining and Documenting The Need To File An IND/IDE Application
The Clinical Research Support Office, Program of IND Assistance(PIA) will provide assistance in determining the need to file an application. To consult with the IND specialist, please bring or send information on your proposal, any available literature documenting safe use in the intended population, or any available drug package insert. Summary guidance as to the need to submit an IND is provided on the FDA IND FAQs page. Assistance can also be provided to arrange an FDA pre-IND consultation if desired.
Overview of IND/IDE regulations
Title 21 of the federal register (21 CFR 312) contains the regulations regarding IND applications. The FDA Center for Drug Evaluation and Research IND Applications page provides links and information about the IND application process and applicable regulations. The information in the pages below provides additional explanations and links to assist investigators in navigating the sites, guidance and regulations. The IND specialist is available to help at all stages of the process.
21 CFR 312 specifies IND regulations for investigators and sponsors relevant to the conduct of FDA-regulated research.
Investigator-Sponsor Obligations
Investigators who are also acting as the sponsor, so-called, "sponsor-investigators", are held to both the responsibilities of sponsors and the responsibilities of investigators.
The sponsor-investigator is responsible for:
- Conducting the study according to the most current approved protocol
- Ensuring clinical monitoring conducted by a qualified individual and is documented
- Obtaining informed consent
- Following the study protocol, and if a change is made, an amendment must be sent to and approved by the FDA.
- Reporting adverse events to FDA.
- Sending annual progress reports to FDA
- Maintaining adequate record keeping of drug disposition
- Maintaining drug disposition logs
- Maintaining adequate data collection forms (case report forms)
- Maintaining adequate safety reports
- Labeling all drug products with an investigational drug label
- Permitting inspection of the study records and reports by FDA and the Program of IND Assistance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/BioresearchMonitoring/ucm052023.htm
Additional instructions and links regarding execution of responsibilities are in the Conduct and Oversight section of this site.
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Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu
