Guidance on Requirements by the FDA for the Investigator as a Sponsor

Version Date: June 14, 2011

Responsibilities of the Investigator-sponsor* under the FDA Regulations

*Investigator-Sponsor refers to a situation in which the individual investigator is both a UW-Madison investigator and is the holder of the IND or IDE and therefore assumes the duties of the sponsor of the clinical investigation under the applicable FDA regulations.


Traditionally the sponsor, a pharmaceutical, biotech, or medical device company, takes responsibility for initiating the clinical investigation, and holding the IND or IDE, but does not conduct the investigation.  However, an individual, group of individuals, or medical center can also be considered a sponsor for an investigation.  In this case, the sponsor-investigator holds the IND or IDE, and is subject to the same requirements under the FDA regulations as the traditional sponsor.

The sponsors' responsibilities generally include the following:

Investigator-Sponsors
An investigator-sponsor for an IND protocol must follow the FDA regulations in 21 CFR 312 applicable to sponsor responsibilities, particularly Subpart D.  This includes:
An investigator-sponsor for an IDE protocol must follow the FDA regulations in 21 CFR 812 applicable to sponsor responsibilities, particularly Subpart C.  This includes:
The Code of Federal Regulations (cited above) may be found on the FDA website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm