Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 203
AAHRPP Elements: I. 7.A.
- SPONSOR-INVESTIGATOR: An individual who both initiates and actually conducts,
alone or with others, an investigation under whose immediate direction the
investigational device is administered, dispensed or used.
- INVESTIGATIONAL DEVICE EXEMPTION (IDE): Exemption from certain
regulations to allow shipment of an unapproved device for use in a clinical
- Sponsor-Investigator Requirements.
- UIC HSPP policy is that a sponsor-investigator assumes all sponsor
responsibilities required by the FDA of the sponsor and the investigator,
including those related to record keeping and prompt reporting of safety
reports to the FDA. Investigators must have a written management plan for
both the sponsor and investigator responsibilities.
- Sponsor-investigator responsibilities 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
- Maintenance of accurate, complete and current records, including
correspondence with the FDA monitor and IRB, records on shipment
and disposition of devices and records of subjects’ case histories and
exposure to the device;
- Completion of regulatory filings, including amendments (supplemental
- Timely submission of reports:
- Unanticipated adverse device effects;
- Progress (regular intervals, but no less than annually);
- Current investigator list (6-month intervals);
- Recall and device disposition (within 30 working days after
request is made);
- Final Report (within 30 days of completion or termination of
- For further information on the FDA requirements:
- Refer to 21 CFR 812, particularly sections:
- 21 CFR 812.40 General responsibilities of sponsors;
- 21 CFR 812.100 General responsibilities of investigators;
- 21 CFR 812.110 Specific responsibilities of investigators;
- 21 CFR 812.140 Records;
- 21 CFR 812.145 Inspections;
- 21 CFR 812.150 Reports.
- Refer to the FDA website for the IDE application.
- IRB Requirements.
- 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.
- Based on the application, the IRB will assess the sponsor-investigator’s
understanding of the following:
- Investigational Device Exemption Application (IDE) and FDA
correspondence (21 CFR 812.20 and 812.30);
- Plan to amend the IDE as needed (21 CFR 812.35);
- Copy of the investigational plan (21 CFR 812.25 and 812.45);
- Summary of prior investigations using the device (21 CFR 812.27);
- Monitoring procedures (21 CFR 812.46);
- Plan to select qualified investigators and monitors (21 CFR 812.43);
- Investigator's CV and relevant experience (21 CFR 812.43);
- Commitment to personally conduct or supervise the investigation (21
- Involvement of other participating institutions (21 CFR 812.20);
- Review of consent materials and plan to obtain informed consent from
each subject (21 CFR 812.2).
- Submission of a signed UIC OPRS form Appendix N attesting that the
investigator has read and understood the FDA regulations listed on the
appendix for a Sponsor - Investigator of clinical trial involving an
investigational agent and agrees to adhere to them.
- Submission to the IRB within 10 working days of FDA audit reports and FDA
form 483, if issued
- Sponsor-Investigators are subject to random compliance audits. A compliance audit
may include a review the following:
- FDA correspondence (21 CFR 812.20 and 812.30);
- Amendments to the IDE (21 CFR 812.35);
- Current copy of the investigational plan (21 CFR 812.25 and 812.45);
- Records of monitoring and review of the study (21 CFR 812.46);
- Informed Consent Forms and materials associated with informed consent;
- Changes to investigators and staff - qualifications of new staff;
- Records of staff training (21 CFR 812.45);
- Complete records for each device received (21 CFR 812.140);
- Records of participants’ case histories (21 CFR 812.140);
- Documentation of unanticipated adverse events and reporting to the IRB and
FDA (21 CFR 812.150);
- Copy of annual progress report to the FDA or plan to write a timely report (21
- Plan for long term record retention (21 CFR 812.140).
Version (#, date)
Replaces (#, date)
Summary of changes
Editorial revisions (updating header, hyperlinks)