Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 202
AAHRPP Elements: I.7.A.
- SPONSOR-INVESTIGATOR: An individual who both initiates and conducts an
investigation, and under whose immediate direction the investigational drug is
administered or dispensed.
- INVESTIGATIONAL NEW DRUG (IND): A drug permitted by the FDA to be tested in
humans but not yet determined to be safe and effective for a particular use in the
general population and not yet licensed for marketing.
- UIC HSPP policy is that a sponsor-investigator assumes all sponsor
responsibilities required by the FDA of both 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
- 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 adequate records showing the receipt, shipment, or
other disposition of the investigational drugs and records of subjects’
- Completion of regulatory filings, including submission of amendments,
annual and final reports;
- Timely submission of reports (adverse events and others);
- Serious, unexpected adverse experiences 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 further information on the FDA requirements, refer to 21 CFR 312, particularly
- 21 CFR 312.57 Recordkeeping and record retention;
- 21 CFR 312.60 General responsibilities of investigators;
- 21 CFR 312.62 Investigator record keeping and record retention; and
- 21 CFR 312.64 Investigator reports.
- For IND Forms and Instructions, please refer to the following, which includes:
- FDA 1571 Investigational New Drug Application;
- FDA 1572 Statement of Investigator;
- Instructions for completing FDA forms 1571 and 1572.
- 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. For more information regarding the IRB review and approval process for research involving drugs or biologics, refer to the UIC HSPP policy Research Involving the Use of Drugs, Biologics, or Medical Devices.
- Based on the application, the IRB will assess the sponsor-investigator’s
understanding of the following, including but not limited to:
- Documentation of the IND application and FDA correspondence with the IND number cited (21CFR 312.20);
- Plan to provide critical information/updates to researchers when
applicable. (21 CFR 312.55);
- Plan to select, supervise and train personnel on an ongoing basis. (21
- Plan for monitoring of ongoing investigation. (21 CFR 312.56);
- Plan for preparation, disposition and destruction of investigational drug.
(21 CFR 312.57, 312.59 and 312.62);
- Plan to comply with reporting obligations (21 CFR 312.32 and 312.33);
- Plan for accurate drug tracking and record keeping. (21 CFR 312.57).
- Submission of a signed UIC OPRS form Appendix O 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:
- Amendments to the IND (21 CFR 312.30 and 312.31);
- Safety records reported to the FDA (21 CFR 312.32 and 312.64);
- FDA Annual Report or plan for timely submission of report (21 CFR 312.33);
- Documentation of any unanticipated adverse events and reporting to the IRB
and FDA (21 CFR 312.64);
- Changes to investigators and staff; qualifications of new staff (21 CFR
- Records of supervision and staff training (21 CFR 312.53 and 312.55);
- Informed Consent Forms (ICF) and materials associated with informed
consent (21 CFR 312.66);
- Records of study monitoring (21 CFR 312.56);
- Records of shipping, labeling, dispensing, and disposal of the drug (21 CFR
312.59 and 312.62);
- Records of subject case histories (21 CFR 312.62);
- Plan for long term record retention (21 CFR 312.62).
Version (#, date)
Replaces (#, date)
Summary of changes
Policy IV.A. revised to reference the drug/biologics/medical device policy. Policy IV.B.1. revised to specify the inclusion of the IND number.