Printed on: 11/21/2019. Please go to http://policy.umn.edu for the most current version of the Policy or related document.
University of Minnisota  Administrative Policy

University Sponsor and Sponsor-Investigator IND/IDE and FDA Pre-Submission Requirements

Responsible University Officer(s):
  • Vice President for Research
Policy Owner(s):
  • Associate Vice President for Research
Policy contact(s):
  • Debra Dykhuis
Date Revised:
Oct 30, 2019
Effective Date:
Nov 1, 2003

Policy Statement

The University has accountability obligations for all University-sponsored and sponsor-investigator drug, device, or biological research and manufacturing at the University. The primary objective is to promote compliance with Food and Drug Administration (FDA) Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) regulations (Significant Risk and Non-Significant Risk) that apply when individuals serve in the role of sponsor or sponsor-investigator. This policy does not apply to research sponsored by an external entity such as a commercial drug or device company, nor to emergency use INDs/IDEs. The Vice President for Research, who serves as Institutional Official under federal regulations, may place limitations or conditions on the privilege of individuals to serve as sponsors or sponsor-investigators.

University Sponsors and Sponsor-Investigators

When individuals serve as a sponsor or sponsor-investigator, they assume the same sponsor obligations under FDA regulations as a commercial drug or device company. Individuals who serve as sponsors or sponsor-investigators must comply with FDA requirements and do the following:

  • register their proposed project with the Human Research Protection Program (HRPP);
  • complete appropriate training as designated by the HRPP;
  • submit required checklists to HRPP outlining their plan to meet FDA reporting and all other FDA requirements that apply to the study;
  • utilize clinical trial monitoring services provided by the University through the Clinical and Translational Science Institute (CTSI) or an equivalent monitoring plan accepted by CTSI; and
  • submit copies of all documents relevant to the FDA pre-submission and the IND/IDE application (as outlined below) to the University’s IND/IDE Central File.

These requirements are in addition to the obligations that apply through the Institutional Review Board (IRB), Conflict of Interest (COI) Program, Sponsored Projects Administration (SPA), Molecular and Cellular Therapeutics (MCT) facility, and any other applicable federal, state, local or University requirements.

Activities that Require Additional Review

The Vice President for Research or designee and the Vice President for Clinical Affairs or designee may require that the HRPP submit higher risk sponsor or sponsor investigator activities to their offices for additional review and approval. These activities include, for example, research where the University sponsor or sponsor-investigator is responsible for the conduct of the trial at multiple institutions or responsible for overseeing University manufacturing at the MCT or other University facility or at other academic or non-profit institutions.

IND/IDE Central File Requirements

For each new protocol, whether Non-Significant risk IDE, Significant Risk IDE or IND or an FDA pre-submission, Sponsors and Sponsor-investigators must submit the following to the University’s IND/IDE Central File, as applicable:

  • IND/IDE exemption or determinations requests
  • IND/IDE pre-submission and application
  • Safety reports
  • Amendments
  • Communications, including transcriptions of calls with the FDA
  • Annual report(s)

The registration must be updated if sponsorship is transferred to another sponsor or sponsor-investigator during the course of the study.

Sponsors and sponsor-investigators are responsible for compliance with FDA reporting requirements. Units must send copies of the FDA related documents to the University’s IND/IDE Central File as they are received or sent.

Non-Compliance

If a sponsor or a sponsor-investigator fails to comply with this policy, the HRPP will notify appropriate institutional leaders and groups including but not limited to the Vice President for Research, the Institutional Review Board (IRB), department head and dean.

The Vice President for Research, who serves as Institutional Official under federal regulations, may place limitations or conditions on the privilege of an individual to serve as sponsors or sponsor-investigators for failure to comply with these requirements.  Depending on the nature and extent of non-compliance, individuals also may be subject to regulatory sanctions by the FDA and/or disciplinary action by the University.

Exclusion

This reporting policy does not apply to the more common situation when a faculty member serves only as the principal investigator on an IND or IDE study, whose sponsor is an outside company, institution, organization, or individual.  Under federal law, the outside sponsor, not the University, is responsible for interactions with the FDA.  The principal investigator, however, remains subject to all other University policies on clinical research.

This policy also does not apply to emergency use INDs/IDEs.

Reason for Policy

This policy promotes compliance with FDA regulations in sponsor-investigator initiated drug, device and biologics studies at the University of Minnesota. The FDA will not directly communicate with the University regarding a sponsor-investigator's pre-submission, IND or IDE interactions. The University, however, is potentially liable for the actions of its faculty members. The requirement for sponsor-investigators to submit copies to the University-wide repository (IND/IDE Central File) will enable the University to monitor the completeness and timeliness of IND/IDE and FDA pre-submission reporting and to respond to inquiries.

This policy also promotes the availability of services to assist sponsor-investigators in interpreting FDA regulations and changes, and communicating with the FDA.

Procedures

Forms/Instructions

Appendices

Frequently Asked Questions

Contacts

SubjectContactPhoneEmail
Primary Contact(s) Debra Dykhuis 612 626-5654 medreg@umn.edu
IND/IDE Central File Form Submission regfile@umn.edu

Definitions

Emergency Use – Drugs and Biologics
Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. The emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB. The exemption, which may not be used unless all of the conditions described in 21 CFR 56.102(d) exist, allows for one emergency use of a test article without prospective IRB review.
Emergency Use - Devices
Emergency use is when there is a need to use a device that has not received the FDA’s approval or clearance in an emergency. Expanded access to an investigational device under the emergency use mechanism is intended to provide patients and physicians with access to investigational devices to address immediately life-threatening situations when there is no available alternative and no time to use existing procedures to obtain FDA approval. 
Food and Drug Administration (FDA)
The regulatory authority in the United States which oversees various industries, including pharmaceutical and medical device industries.
Human Research Protection Program (HRPP)
Institution-wide program that includes University individuals and committees responsible for protecting the rights and welfare of participants in research.
Institutional Official
Individual who is legally authorized to act for and obligate the University to provide the resources and support necessary to comply with all requirements for human subjects research, consistent with federal regulations and our Federal Wide Assurance with the federal government.
Investigational Device Exemption (IDE)
FDA regulation to allow for the conduct of a clinical study using a device that is new or not used in accordance with the approved labeling. IDE also refers to documentation submitted to and received from the FDA regarding an IDE for significant risk devices.
Investigational new drug application (IND)
FDA regulation to allow for the conduct of a clinical study using a drug or a biological product that is new or not used in accordance with the approved labeling. IND application refers to documentation and correspondence submitted and received from the FDA regarding an IND.
Investigator
Investigator is an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the investigational device, biologic or drug is administered, dispensed to, or used involving a subject. In the event of an investigation being conducted by a team of individuals, "investigator" refers to the responsible leader of that team.
Sponsor
An individual, company, institution, or organization that takes responsibility for and initiates a clinical study, but does not conduct an investigation.
Sponsor-Investigator
Sponsor-investigator is an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the investigational device, biologic or drug is administered, dispensed, or used. The term does not, for example, include a corporation or agency. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor.
Pre-FDA Submission for IND/IDE
A process to establish an IND/IDE. Also refers to documentation and correspondence submitted to and received from the FDA.

Responsibilities

Sponsor
Comply with FDA requirements. Register proposed project with the HRPP. Complete training designated by HRPP. Submit required checklists to the HRPP outlining plan to meet FDA requirements. Utilize clinical trial monitoring services through CTSI or equivalent monitoring plan accepted by CTSI.
Submit copies of all relevant documents (pre-FDA submission, IND/IDE application, all communications to and from the FDA, safety reports, initial protocol, protocol amendments, and annual reports) to the IND/IDE Central File. Verbal communications with the FDA should be transcribed and filed with the Central File.
Sponsor-investigator
Comply with FDA requirements. Register proposed project with the HRPP. Complete training designated by HRPP. Submit required checklists to the HRPP outlining plan to meet FDA requirements. Utilize clinical trial monitoring services through CTSI or equivalent monitoring plan accepted by CTSI.
Submit copies of all relevant documents (pre-FDA submission, IND/IDE application, all communications to and from the FDA, safety reports, initial protocol, protocol amendments, and annual reports) to the IND/IDE Central File. Verbal communications with the FDA should be transcribed and filed with the Central File.
Human Research Protection Program (HRPP)
Provide free, optional assistance to faculty members who are seeking FDA pre-submission guidance, preparing an IND or IDE to the FDA or need guidance as to whether an IND or IDE is required. The HRPPwill receive and review all required checklists outlining plan to meet FDA requirements. Designate appropriate training required for individuals requesting to serve as sponsor-investigator. At the direction of the Vice President for Research or designee and the Vice President for Clinical Affairs or designee, HRPP shall forward higher risk sponsor or sponsor investigator activities to their offices for additional review and approval. The HRPP will operate the IND/IDE Central File as an obligatory requirement for all sponsor-investigators of an IND/IDE or a pre-IND/IDE. The central file includes all documents relevant to a sponsor-investigator pre-IND/IDE or IND/IDE held by a faculty member. Report suspected or known instances of noncompliance with University, FDA, or other applicable policies to the appropriate institutional leaders and groups, including but not limited to the Vice President for Research, IRB, department head and dean.
Institutional Official (IO)
If warranted, place limitations or conditions on the privilege of individuals to serve as sponsors or sponsor-investigators; and for failure to comply with applicable FDA or University policy requirements.
Vice President for Clinical Affairs
Determine whether additional review and approval is required at the senior level for certain types of higher risk sponsor or sponsor investigator activities. If so, provide that review and determine whether to approve the sponsor or sponsor-investigator study, acting personally or through a designee.
Vice President for Research
Determine whether additional review and approval is required at the senior level for certain types of higher risk sponsor or sponsor investigator activities. If so, provide that review and determine whether to approve the sponsor or sponsor-investigator study, acting personally or through a designee. 

Related Information

History

Amended:
October 2019 - Comprehensive Review, minor revision. Title change from: Reporting Sponsor-Investigator IND/IDE and FDA Pre-Submissions to: University Sponsor and Sponsor-Investigator IND/IDE and FDA Pre-Submission Requirements
Amended:
July 2015 - Comprehensive Review. Major Revision. Reflects the change of the documentation unit to IND/IDE Central File. Includes a requirement to provide transcripts of conversations with the FDA.
Effective:
November 2003

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