UNIVERSITY OF MINNESOTA
INSTITUTIONAL REVIEW BOARD
REVISED NOV 2012
Appendix E
Use of Drugs and/or Biological Products in Research
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Researchers planning to include approved or unapproved drugs or biological products in
research projects must complete this form.
Complete Appendix E for each Drug or Biological Product.
Researchers are reminded that the word “experimental” must appear in the consent form to
modify the drug names. (see 21 CFR 312)
Research involving drugs/biologics is typically not eligible for expedited review.
1. Identify the drug(s) or biological product(s):
Trade name of Drug or Biological Product
Generic name (if drug) or Biological name
Manufacturer of the product to
be used in this study
2. Drug/biological product information:
 For industry protocols, provide the Investigator’s Brochure or package insert.
 For investigator-initiated protocols for marketed drug or biological product provide the
package insert
 For investigator-initiated protocols for drug or biological product not currently approved by
FDA for this use, dosage form, or population, provide the following:.
Chemical Structure
Pharmacology
Form of Administration
Maximum Tolerated Dose in Humans
Toxicity Observed
Pharmacokinetics Data
Procedures for minimizing adverse events in humans
3. Regulatory status of drug/biological product:
 Does this drug or biological product have an Investigational Drug Number (IND) for this
study?
Yes.
Yes.
IND #:
Who holds the IND?
Investigator (Attach a Protocol Meeting GCP Guidelines):
(name on Form FDA Manufacturer:
1571, sec.1)
Other: e.g., consortium, COG, GOG, CTEP, NIH:
Treatment IND#
Is there a charge for study medication? Yes No
If there is a charge for study medication who is responsible for paying for study medication. (Be aware that
many insurance companies and Medicare will NOT pay for study medications):
Does the consent form clearly state who is responsible for paying for study medication?
Yes No
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Use of Drugs and/or Biological Products in Research – Appendix E
UNIVERSITY OF MINNESOTA
No.
INSTITUTIONAL REVIEW BOARD
REVISED NOV 2012
Are you or your funding source intending to report the study results to the FDA to support
a new indication or labeling change?
Are you or your funding source intending to report the study results to the FDA to support
a change in the advertising?
Does the planned use of the study drug involve a route of administration or dosage level or
use in a patient population or other factor that significantly increases the risks (or decreases
the acceptability of the risks) associated with the use to the subjects being studied?
Does the study require any change in the approved formulation, dosage form, or route of
administration of the drug?
If yes to the previous question, will this change the risks to subjects participating in the
research?
Will the subjects be charged for the investigational drug?
Are there other FDA approved drugs used to treat the condition you plan to study?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Yes
No
No
Please review the University of Minnesota “Using Legend and Investigational New Drugs for Clinical
Research” policy (2.1.9) and procedures 2.1.9.1 to ensure that you are in compliance with Minnesota
law and University policy. University Policy – Reporting Sponsor-Investigator INDs or IDEs.
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If the commercial regulatory sponsor has determined that an IND is not required for
this study (i.e., IND exempt) a copy of that assessment must be attached.
If you are the sponsor-investigator and have determined that an IND is not required for
this study, a copy of your assessment must be attached.
4. 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 the Drug or Biological
Product is approved 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.
Investigational Drug Service Number (IDS#):
#
(List all that apply)
IDS Pharmacy is dispensing study medication – Proceed to Section 5.
Study medication(s) is/are all commercial medications and will be dispensed by a licensed
pharmacy – Proceed to Section 5.
Study medication(s) will be dispensed by physician – Complete entire Section 4.
A. Per Minnesota Statute: If medication is not dispensed by a pharmacist, medication may
only be dispensed by a physician, physician’s assistant (in agreement with the physician),
or a nurse practitioner (in agreement with the physician). List the person(s), along with
their degree (and who they have a written practice agreement with – if applicable),
responsible for dispensing medication to the patient:
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Use of Drugs and/or Biological Products in Research – Appendix E
UNIVERSITY OF MINNESOTA
INSTITUTIONAL REVIEW BOARD
REVISED NOV 2012
B. Good Clinical Practice (GCP) requires medication to be stored at the proper
temperature. To meet expectations, GCP also requires that the daily temperatures be
monitored and recorded
a. What are the temperature requirements for storage of study medications?:
i. Room temperature (20-25oC or 68-77oF):
ii. Refrigerator temperature (2-8oC or 36-46oF):
iii. Freezer temperature (-20oC):
iv. Ultra-low freezer temperature (-70 to -80oC):
b. Please indicate which recording method is used to record daily temperatures:
i. Chart recorder:
Yes No
ii. Minimum/maximum thermometer:
Yes No
iii. Other (explain):
c. If medication is stored at refrigerator or freezer temperatures:
i. Is there a back-up power source in the event of a power outage?
Yes No
ii. Is the refrigerator or freezer alarmed to alert staff in the event of a power
outage?
Yes No
iii. Medications may not be stored in a refrigerator or freezer that contains
food or lab samples – the only thing allowed to be stored in the refrigerator
or freezer is medication. Confirm medication will be stored in a dedicated
medication storage refrigerator:
Yes No
C. Per Minnesota Board of Pharmacy Rules medications need to be stored in a separate
locked drug storage area. Access shall be limited to persons who have legal authority to
dispense and to those under their direct supervision. Provide information on storage and
access of study medication:
D. Emergency Unblinding: In the event of an emergency how will the contents of a drug
container be identified? This information is expected to be available 24 hours a day/7 days
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UNIVERSITY OF MINNESOTA
INSTITUTIONAL REVIEW BOARD
REVISED NOV 2012
a week (24/7) in a timely manner – EXPECTED TURN-AROUND TIME FOR THE
UNBLINDING PROCESS TO BE COMPLETED IS 20 TO 30 MINUTES.
a. Explain the process to be followed – including the telephone numbers and contact
information – to unblind a subject in the event of an emergency.
b. How will the subject know who to contact in the event of an emergency? How is
this information going to be provided to the subject (this information may be
provided in the consent form – but also must be provided in an additional
manner):
These are examples of acceptable methods: the emergency unblinding contact
number is printed on the medication bottle dispensed to the patient/subject OR the
patient/subject is given a wallet card with emergency unblinding contact
information OR the patient/subject is given the PI’s 24/7 contact telephone
number.
E. Labeling of study medication: In addition to the Federal requirements for proper labeling
of study medication, Minnesota State Board of Pharmacy rules and statutes must also be
following. Some of the information may be on the sponsor’s label. Additional information
will need to be affixed to the drug container. The following information must be on the
medication container dispensed to the subject/patient:
a. Name, address, and telephone number of clinic of physician’s office
b. Prescribing physician’s name
c. Patient’s name – may be initials or subject number
d. Date of dispensing
e. ‘Prescription number’ – may be a visit number with a date – has to unique to the
patient and the patient’s visit
f. Directions for use
g. Drug name or study name or protocol name or protocol number
h. Name of manufacturer or distributor of finished dosage form
i. Any necessary auxiliary labels
j. A ‘prescription order’ must be made – this is in addition to any notes/records
made in the patient’s chart.
Verify that all the above information is on the drug container:
Yes No
5. For all studies that are investigator-initiated (sponsor-investigator holds the IND):
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Use of Drugs and/or Biological Products in Research – Appendix E
UNIVERSITY OF MINNESOTA
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INSTITUTIONAL REVIEW BOARD
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Attach a protocol that meets Good Clinical Practice (GCP) guidelines.
Provide Form FDA 1572 and Form FDA 1571.
Will data integrity be monitored by the CTSI? Yes. No.
If no, indicate who will be monitoring for data integrity, FDA and GCP compliance:
6. For all studies that are registered with ClinicalTrials.gov:
ClinicalTrials.gov Identifier:
(List all that apply)
NCT#
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Use of Drugs and/or Biological Products in Research – Appendix E