INDIANA UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)
DRUG OR BIOLOGICAL PRODUCT FORM
IRB STUDY NUMBER:
PRINCIPAL INVESTIGATOR:
DOCUMENT DATE:
FORM #:
OF
Most investigations of drugs or biological products require submission of an Investigational New Drug Application (IND) to the FDA.
Hereafter, the use of the term ‘drug’ includes a biological product. If the study involves a drug used in humans in any way other than in
the course of medical practice, an IND is required unless certain exemptions apply. Exemptions are some investigations of already
approved drugs (SECTION II), some studies using diagnostic biological products and in vitro drug tests (SECTION III), and some
bioavailability or bioequivalence studies (SECTION IV). For additional background see 21 CFR § 312.2. A study that is exempt from
the IND requirement must still comply with FDA requirements for IRB review (21 CFR § 56) and informed consent (21 CFR § 50).
Some of the questions below require the exercise of scientific/medical judgment. You are required to submit to the IRB, along with this
form, documentation and/or reasoning that supports your conclusion. The IRB uses this form as a tool to gather information. The
conclusions reached in this document are preliminary. If any question remains upon IRB review regarding whether an IND would be
required, you will be asked to submit a request to FDA and provide that documentation to the IRB. The FDA will make the ultimate
determination of whether your investigation requires an IND. If this is emergency research involving an exception to the requirement
that subjects give informed consent, an IND is required and an amendment to an existing IND will not suffice.
Please proceed through the form from the beginning and follow the listed flow instructions carefully. As this can be complex yet
very critical information to work through, please contact the Quality Improvement Office (QIO) at 317-278-7189 or the Human
Subjects Office at 317-274-8289 (irb@iu.edu) if you have any questions or need assistance. Also, if you need assistance with
obtaining an IND or IND exemption, you can contact the QIO or the Indiana Clinical Translational Sciences Institute at
invdrdev@iupui.edu.
NOTE: Please complete a separate Drug or Biological Product Form for each drug listed in Questionnaire B – Lay Summary &
Research Design of the KC IRB submission, and number each form consecutively in the header.
Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”.
SECTION I: ABOUT THE DRUG OR BIOLOGICAL PRODUCT BEING STUDIED
A. Name of Drug:
Name of Drug Manufacturer:
Study Phase:
1.
I
I/II
II
II/III
III
III/IV
IV
Has an IND been obtained from the FDA for the above named product for use in this study?
Yes. Complete a. through d. You do not need to complete Sections II through IV.
a. IND Number:
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b.
Provide verification of the IND number (choose all that apply):
Documentation from the FDA provided.
IND number included in the sponsor protocol. List the page number where the IND number is located:
c.
Does the local investigator hold the IND?
No.
Yes. Before approval can be granted, the investigator must meet with QIO staff to discuss the additional
responsibilities as a sponsor of an IND. Please contact the QIO at (317) 278-7189 and submit documentation from
them verifying this discussion has taken place.
d.
Will services of the Investigational Drug Services (IDS) be used?
Yes.
No. The investigator must demonstrate understanding of the handling and control of investigational test articles
by reviewing the SOP for Research with Investigational Test Articles. Check here
to confirm the investigator has
read the SOP and agrees to comply with the policies and procedures outlined. Describe how these requirements will
be met including who, what, where, how test articles will be handled, controlled, dispensed, etc.:
IRB Form v07.2015
No. Has an IND exemption been obtained from the FDA?
Yes. Provide the related documentation and this form is complete and ready for submission to the IRB.
No. Continue to SECTION II.
SECTION II: STUDIES INVOLVING LAWFULLY MARKETED DRUGS
A. Is this product a lawfully marketed drug?
No. Continue to SECTION III.
Yes.
TRUE
1.
2.
3.
4.
5.
6.
7.
8.
FALSE
The product IS lawfully marketed in the United States. You may answer TRUE to this statement even if
the study includes the use of a placebo. NOTE: Submit documentation of FDA approval such as the
package insert.
The study does NOT involve a route of administration that significantly increases the risks (or decreases
the acceptability of the risks) associated with the use of the product.1 NOTE: Submit product labeling
(e.g., package insert) showing the product's approved route of administration.
The study does NOT involve a dosage level that significantly increases the risks (or decreases the
acceptability of the risks) associated with the use of the product. 2 NOTE: Submit product labeling
showing the product's approved dosage level.
The study does NOT involve use of a product in a patient population that significantly increases the risks
or decreases the acceptability of the risks associated with the use of the product (for example, use in a
vulnerable subject population such as children, cognitively impaired individuals, pregnant women, human
fetuses, or fetal material, or prisoners that significantly increases the risks or decreases the acceptability
of the risks). NOTE: Submit product labeling showing the product's approved patient population.
The study does NOT involve any other factor that significantly increases the risks or decreases the
acceptability of the risks associated with the use of the product. 3 NOTE: If the product will be used
inconsistently with the product's approved labeling, provide explanation as to why, in your
professional judgment, the risks to subjects are not significantly increased.
The study is NOT intended to be (and is not likely to be) reported to the FDA as a well-controlled study
in support of a new indication or use.
The study is NOT intended to support any other significant change in the product labeling.
The study is NOT intended to support a significant change in the advertising for the product.
If you answered TRUE to ALL of the statements in this table, the use of this drug in this study is likely exempt from the requirement
to submit an IND application to the FDA; thus, the form is complete and ready for submission to the IRB. Conversely, a FALSE
answer in any box means an IND or an IND exemption from the FDA is required; therefore, SECTION I above will need to be
completed to reflect the IND or IND exemption information and SECTIONS III and IV below do not require completion.
SECTION III: DIAGNOSTIC BIOLOGICAL PRODUCTS AND IN VITRO DRUG TESTS
A. Is this product a diagnostic biological product?
(Most diagnostic products are regulated as devices; please see the Medical Device Form if your product is not one of the 3
biological diagnostic products listed in row 1. in the following table.)
No. Continue to B.
Yes.
Studies Involving In Vitro Diagnostic Biological Products
TRUE
FALSE
1
For example, FDA presumes that a change from any dosage form to intravenous or intrathecal (including a change from
intramuscular to intravenous) would significantly increase the risk and warrant an IND.
2
FDA has stated that use of an OTC drug to treat a life-threatening illness, or to prevent irreversible damage, would likely trigger the
need for an IND. Similarly, an IND should be submitted for a study of a prescription drug approved for treatment of a serious or lifethreatening disease or condition, when the study uses the drug at a dose significantly lower than the labeled dose.
3
FDA recognizes that a considerable amount of professional judgment must be exercised in making this determination. Deviations
from the approved labeling should be carefully scrutinized to ensure that the risks to subjects are not significantly increased.
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IRB Form v07.2015
1.
2.
3.
The in vitro diagnostic biological product IS one of the following types of product: (1) blood grouping
serum; (2) reagent blood cells; (3) anti-human globulin. NOTE: Submit documentation confirming
the identity of the diagnostic as one of the 3 listed.
The diagnosis made using the test article WILL be confirmed using another, medically established,
diagnostic product or procedure. NOTE: Please submit documentation to support this conclusion.
The test article will be labeled and shipped in accordance with FDA requirements for Drugs for
Investigational Use in Laboratory Research Animals or In Vitro Tests. (For additional background see
21 CFR § 312.160).
If you answered TRUE to ALL of the statements in this table, the use of this drug in this study is likely exempt from the requirement
to submit an IND application to the FDA; thus, the form is complete and ready for submission to the IRB. Conversely, a FALSE
answer in any box means an IND or an IND exemption from the FDA is required; therefore, SECTION I above will need to be
completed to reflect the IND or IND exemption information. Question B. below and SECTION IV do not require completion.
B. Is this product intended solely for tests in vitro or for use in laboratory animals?
No. Continue to SECTION IV.
Yes.
Studies Involving Drugs Intended Solely for Tests In Vitro or for use in Laboratory Animals
1. The test article intended solely for tests in vitro or in laboratory animals WILL be shipped in
accordance with FDA regulations. (For additional background see 21 CFR § 312.160).
TRUE
FALSE
If you answered TRUE to the statement in this table, the use of this drug in this study is likely exempt from the requirement to submit
an IND application to the FDA, thus, the form is complete and ready for submission to the IRB. Conversely, a FALSE answer in any
box means an IND or an IND exemption from the FDA is required; therefore, SECTION I above will need to be completed to reflect the
IND or IND exemption information. SECTION IV below does not require completion.
A.
1.
2.
3.
SECTION IV: BIOAVAILABILITY OR BIOEQUIVALENCE STUDIES
Is this study a bioavailability or bioequivalence study?
No. Please contact the HSO or CRCO for assistance as further assessment or clarification is necessary.
Yes.
Bioavailability/Bioequivalence Studies in Humans
TRUE
The study is NOT one of the following types of studies: (1) a study involving a test product that
contains a new chemical entity; (2) a study involving a radioactively labeled drug product; (3) a
study involving a cytotoxic product.
The maximum single dose or total daily dose DOES NOT exceed that specified in the product's
approved labeling. NOTE: Submit product labeling to support this conclusion.
The study is NOT a multiple dose study on an extended release product on which no single dose
study has been completed.
FALSE
If you answered TRUE to ALL of the statements in this table, the use of this drug in this study is likely exempt from the requirement
to submit an IND application to the FDA; thus, the form is complete and ready for submission to the IRB. Conversely, a FALSE
answer in any box means an IND or an IND exemption from the FDA is required; therefore, SECTION I above will need to be
completed to reflect the IND or IND exemption information.
NOTE: For BA/BE studies conducted in the United States, even if the study is exempt from the requirement to file an IND, the
investigator conducting the study must notify the FDA and all participating investigators of any serious adverse event that is observed
in the BA/BE study, as soon as possible but in no case later than 15 calendar days after becoming aware of its occurrence, regardless
of whether the event is considered drug-related and whether the event is observed in the investigational drug arm or an approved drug
arm. (For additional information see 21 CFR § 320.31(d)(3)).
Please submit this form with all of the appropriate supporting documentation to the IRB. This form is to be treated as any other
document submitted to the IRB for review (e.g., requires submission of an amendment if there are changes to the information on this
form after initial IRB approval and is also required to be submitted at the time of renewal).
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IRB Form v07.2015