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PI Name:
Project title or IRB #:
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Date: Click here to enter a date.
Instructions for completing this form:
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Researchers planning to include a drug, Generally Regarded As Safe (GRAS) substance or biological product not legally distributed in the United States interstate commerce, even if the research question is not about this product, must complete this form.
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Researchers planning to include a commercial drug, GRAS substance or biological product that is studied for a new indication, new patient population, new dosage or other modifications, must complete this form.
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All researchers using tobacco must complete this form.
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This form does not apply to drugs, GRAS substances or biological products that are legally distributed in the United States interstate commerce and are used identically to their corresponding Prescribing
Information and Labeling, except for those products being investigated for safety and effectiveness (the product is the subject of your research).
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Notwithstanding the above provisions, the IRB may request Appendix E if more information about the drug is needed to aid in its evaluation of human subjects’ research.
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Complete a separate Appendix E for each drug, GRAS substance, tobacco or biological product.
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For investigational products, researchers are reminded that the word “experimental” or “investigational” must appear in the consent form to modify the drug names. ( see 21 CFR 312 )
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For questions about this form please contact the HRPP office at medreg@umn.edu
Research involving investigational drugs, biologics or Tobacco is rarely eligible for expedited review.
Product Identification: Drug, Biologic, GRAS Substance or Tobacco
Trade name of Drug or Biological product:
Generic name:
Manufacturer of the product to be used in this study:
If a drug, is this drug or chemical considered a controlled substance ?
http://www.fda.gov/regulatoryinformation/legislation/ucm148726.htm
Yes No Not applicable
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This section is only applicable to FDA approved products or those legally in
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1.1 Check one:
New Drug Application (NDA) # or Biological License Application (BLA) # for approved drug/biologic
Exempt from the IND requirements per FDA Guidance “Guidance for Clinical Investigators, Sponsors, and IRBs –
Investigational New Drug Applications (INDs) Determining Whether Human Research Studies Can be Conducted
Without an IND”
If Exempt, this section is complete. Go to Section 3
Need Assistance determining the status?
If you are unsure of the FDA classification the most direct source of assistance is the drug manufacturer. You may also contact the UMN HRPP (medreg@umn.edu) office for assistance.
1.2 Provide the FDA approved prescribing information for this particular drug or biological product
or
See attachment labeled:
1.3 How is the drug/biologic to be used differently than the FDA approved labeling, including but not limited to dosage and patient population?
Provide an explanation
Section 2 – FDA Regulatory Status of the Investigational Drug/Biologic/GRAS
Substance/Tobacco Product
2.1 Is this a combination product as defined by FDA per 21 CFR 3.2(e) ?
No Yes If yes is checked, provide any information about the device or the FDA determination
that will aid the IRB in review of this application:
2.2 Check the box next the description of the current IND status. If IND has been assigned or pending, answer the additional questions below.
No IND or Protocol for Tobacco
number (neither pending nor assigned)
Section Complete – go to Section 3 Investigational New Drug
Requirements/Exemption
An IND or Protocol for Tobacco
number is PENDING (an application has been submitted to the FDA)
An IND or FDA Protocol for Tobacco number has been ASSIGNED
Expected date of receipt of documentation
Who is the sponsor (holder) of the IND or Tobacco Protocol?
Enter the complete IND or Tobacco Protocol Number:
Who holds the IND or Tobacco Protocol?
Validation of IND or Tobacco protocol number is required.
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Provide both of the following with your application:
Written communication from the FDA
Sponsor protocol imprinted with an IND or a protocol for
Tobacco number
2.3 A copy of the Investigator’s Brochure, package insert or a copy of the Pharmaceutical Quality Control/CMC
section of the sponsor-investigator’s IND application must be provided with the IRB application.
Indicate how this information is provided:
via a UMN Central File submission
attached to this application
Section complete. Go to Section 4 – Drug Management and Accountability
Section 3 – Investigational New Drug Requirements/Exemption
This section must be completed if an IND number is neither pending nor assigned.
Under FDA regulations, research that involves use of a drug other than the use of a marketed drug in the course of medical practice, must have an IND, unless the study meets one of the exemptions from the
IND requirement at 21 CFR 312.2(b) . Complete the following to document that the study is being conducted under a valid IND or the study is exempt from IND requirements.
3.1 Check the box indicating whether statement A, B or C applies:
Statement A This study involves Approved Use (per approved labeling) of FDA Approved
Drug(s). Use must not involve a route of administration, dosage, patient population or other factor which significantly increases risks, or decreases acceptability of the risks, and; the results are not intended to be reported to FDA in support of a change in labeling/marketing.
The FDA approved package insert for the product must be submitted with the
IRB application.
Go to question 3.2
Statement B The Investigator, absent a ruling from FDA, believes the study meets Exemption
Category A: Approved Drug or Biologic or GRAS for Unapproved Use
Complete the Exemption Category A Worksheet below
Statement C The investigator has obtained/will obtain documentation from the sponsor or
FDA to confirm study is Exempt from IND requirements [21 CFR 312.2(b)(i)].
Note that final approval will not be granted until documentation is provided to the IRB
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Go to question 3.2
Exemption Category A Determination Worksheet
Is this drug, biologic or GRAS substance lawfully marketed in the United States?
Yes No If NO, the criteria for exemption is not met.
Yes No If YES, criteria for exemption is not met. Are you or your funding source intending to report the study results to the FDA to support a new indication or a significant labeling change?
Are you or your funding source intending to report the study results to the FDA to support a change in the advertising?
Yes No If YES, criteria for exemption is not met.
Does the planned use of the study drug involve a change in route of administration, dosage level or use in a patient population that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product (21 CFR
312.2(b)(1)(iii)?
Is the research conducted in compliance with the marketing limitations described in 21CFR312.7?
Yes
Yes
No If YES, criteria for exemption is not met.
No If NO, criteria for exemption is not met.
3.2 Does the protocol involve any of the following? Select all that apply.
In-Vitro diagnostic Cold Isotopes
Endogenous compounds
Live organisms
Other products intended to evaluate ability to diagnose, cure, mitigate, treat or prevent disease
Positron emission tomography (PET) drugs
Bioavailability or Bioequivalence Studies
Combination (drug/device) products
Dietary supplements, botanicals, or other substances designated as generally recognized as safe (GRAS) for use in food
None apply
If the protocol involves any of the above and the researcher is claiming exemption from an IND/Protocol Number, be aware that the FDA has very specific criteria which must be met . Provide an explanation of how you satisfy exemption.
The IRB may require you to provide documentation of concurrence from the FDA if questions remain about the exemption status of the investiga tion.
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Section 4 - Drug Management and Accountability, All Drugs/Biologics/GRAS
Substance/Tobacco
All drug and biological product studies must, at a minimum, be registered with the Investigational Drug Service
(IDS), 612-273-6212. This is true whether or not the drug or biological product is investigational or not. The number assigned by the Investigational Drug Service must be submitted to the IRB in order to receive final approval for this study.
Is the IDS Pharmacy dispensing study medication?
Yes Provide the IDS number:
No Provide the IDS RO (Registered Only) Number:
Who will dispense the study medication?
Study medication(s) will be dispensed by physician
-OR-
Study medication(s) is/are all commercial medications and will be dispensed by a licensed pharmacy
Section 5 – Special Considerations for Investigator Initiated Research
Sponsor-investigators are required to complete the web-based Good Clinical Practice Course available through the
Collaborative Institutional Training Initiative (CITI). This course provides guidance on the regulatory and institutional responsibilities of the sponsor-investigator role in drug studies. This training must be successfully completed before IRB approval is granted.
5.1 Is this study investigator initiated (the PI is initiating and conducting, either alone or with others, a clinical investigation). This section refers to Sponsor-investigator definition per 21 CFR 312.3
.
Yes No. If no, section complete.
5.2 Provide the date (Month/Year) the PI completed the required CITI course for sponsor-investigators.
5.3 Has the PI transferred any sponsor obligations/responsibilities to the commercial sponsor,
University of MN or contract research organization, or other entity?
Yes indicate roles and responsibilities transferred:
No
5.4 Check the boxes next to the statements below to confirm understanding and agreement:
The Principal Investigator confirms he/she is aware of the regulatory responsibilities as a sponsorinvestigator
The Principal Investigator confirms he/she will comply with the University of Minnesota Policy “ Reporting
Sponsor-Investigator IND/IDE and FDA Pre-Submissions ”
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