Indiana University Health Bloomington Institutional Review Board (IRB)
DRUG OR BIOLOGICAL PRODUCT FORM
Principal Investigator:
IRB Study Number:
Document Date:
Study Title:
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 IRB Office at 812-3532847 if you have any questions or need assistance.
NOTE: Please complete a separate Drug or Biological Product Form for each drug listed in Section III, A., 1.
of the Study Summary Statement (SSS) 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:
I
II
III
IV
1. 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 the IRB Office
to discuss the additional responsibilities as a sponsor of an IND.
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 Investigational 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.:
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
FALSE
1. 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.
2. 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.
3. 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.
4. 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
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.
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5.
6.
7.
8.
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 wellcontrolled 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
1. 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.
2. 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.
3. 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).
TRUE
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. Question B. below and SECTION IV do not require completion.
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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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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 IRB Office 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
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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 Continuing Review).
This form must be electronically signed by the Principal Investigator or designee. The electronic signature
certifies that the information provided above is accurate, current and complete.
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