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
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 (within 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 (within 30 working days after
request is made);
Final Report (within 30 days of completion or termination of
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);
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: