FDA Compliance for Sponsor-Investigator IND-IDEs

The Office of Research Compliance and Regulatory Affairs is now reviewing FDA documents for Sponsor-Investigator protocols requiring an IND or IDE prior to IRB review, as per IRB Policy III.08.(see policies)  

An IND is an Investigational New Drug application. It is a request to the FDA to allow the administration of investigational drugs to humans.

An IDE is an Investigational Device Exemption. It is documentation submitted to the FDA to allow for the conduct of a clinical study using a significant risk device that is new or not approved for that use.

The FDA defines a Sponsor-Investigator as a Principal Investigator that initiates and conducts an investigation and must comply with all the obligations of both a Sponsor and an investigator (21 CFR §312 Subpart D; 21 CFR §812 Subparts C & E:  

A Sponsor

• Must be an individual, not the University, College of Medicine, a Practice Corporation or a Federal Agency
• Does not refer to the agency which provides support for the research
• Agrees to provide for independent data monitoring of the research

Investigators are required to submit

• For INDs - a copy of the 1571 submitted to the FDA
• For IDEs - a copy(s) of the signed Investigator's Agreement for conducting the study
• Copy of the letter from the FDA assigning the IND/IDE number
• A copy of all labels and labeling for the investigational product
• Clinical monitoring plan including name, address and qualifications of monitors