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:
- Selecting qualified investigators;
- Providing investigators with the information they need to conduct the investigation properly;
- Ensuring proper monitoring of the investigation;
- Ensuring that the FDA, any reviewing IRBs, and all participating investigators are promptly informed of significant new information about an investigation, including significant new adverse events or other risks of the test article.
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:
- Filing protocol amendments when required by 21 CFR 312.30;
- Notifying the FDA and participating investigators of adverse events as required in 21 CFR 312.32;
- Filing annual reports with the FDA as required by 21 CFR 312.33;
- Record keeping requirements of 21 CFR 312.57; and
- Promptly reporting as required in 21 CFR 312.56(b) to the FDA and all participating investigators of significant new adverse effects or risks with respect to the drug or biologic.
- Filing supplemental applications when required by 21 CFR 812.35;
- Record keeping requirements of 21 CFR 812.140(b);
- Filing annual reports with the FDA as required by 21 CFR 812.150(a)(3); and
- Required notification under 21 CFR 812.150(b)(1) to the FDA and all participating investigators of any evaluation of an unanticipated device effect within ten (10) working days of first receiving notice of the effect.