Sponsor-Investigator Research (SIR) Requirements
A Sponsor-Investigator assumes all responsibilities of both the “sponsor“ and the “investigator” as required by the FDA under 21 CFR 312 (drugs) and 21 CFR 812 (medical devices), including those related to record keeping and prompt reporting of safety reports to the FDA.
| Sponsor-Investigator |
|---|
| An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to or used involving, a subject. The term does not include any person other than an individual, e.g., corporation or agency. |
Sponsor-Investigator Responsibilities
Responsibilities of a sponsor-investigator include:
- Selection of research staff qualified by training and experience;
- Commitment to personally conduct or supervise the investigation according to the research plan;
- Selection of study monitor(s) qualified to monitor the progress of the project;
- Maintenance of accurate, complete and current records, including correspondence with the FDA, monitor and IRB, records on shipment and disposition of drug/devices and records of participants’ case histories;
- Completion of regulatory filings, including submission of amendments (supplemental applications), annual and final reports; and
Timely submission of reports:
For investigational drugs under an IND:
- Serious, unexpected adverse events associated with the use of the drug
- Written reports (no later than 15 days from observation),
- Telephone or facsimile reports (no later than 7 days from observation if fatal or life-threatening event);
- Any findings from tests in laboratory animals that suggest significant risk for human subjects; and
- Other reports:
- Annual report (within 60 days of the anniversary date the IND went into effect).
For medical devices under an IDE:
- Unanticipated adverse device effects (10 working days of learning of event)
- Progress (regular intervals, but no less than annually)
- Current investigator list (6-month intervals)
- Recall and device disposition (30 working days after request is made)
- Final Report (within 30 days of completion or termination of investigation)
- Serious, unexpected adverse events associated with the use of the drug
If the Stanford investigator is the sponsor of a Non-Significant Risk device study, see Research with Medical Devices.
IRB Review Requirements of Sponsor-Investigator Research
Prior to approving a protocol that involves a sponsor-investigator, the IRB must be satisfied that the sponsor-investigator is knowledgeable about his/her responsibilities and has adequate policies and procedures in place to comply with the FDA regulatory requirements. The IRB may rely on feedback from the Stanford entity providing the education in its determination of proficiency, but may also contact or conduct a site visit of the sponsor-investigator as deemed necessary. For background on this requirement, see the Memorandum from Dr. Ann Arvin, Dean of Research.
After submission of a new sponsor-investigator protocol, the Protocol Director and Administrative Contact on a sponsor-investigator project will receive an email from the IRB that SIR training will be required. Either Spectrum or the Cancer Clinical Trials Office (CCTO) will follow-up with information on arranging the education session.
A review designed to evaluate compliance with the FDA regulatory requirements will be conducted on at least an annual basis and is a condition of continuing review approval by the IRB. The SIR IND/IDE Annual Self-Assessment Checklist will need to be completed and submitted with the continuing review application.
Assistance and consultation are available for researchers planning to submit IND or IDE applications to the FDA. Contact Spectrum at regulatory-spectrum@lists.stanford.edu or the Cancer Clinical Trials Office (for cancer studies) at ccto-regulatory@stanford.edu for information.
Page updated June, 2026