Download IND Exemption Determination

REVIEWER CHECKLIST
INVESTIGATIONAL NEW DRUG (IND) APPLICATION DETERMINATION
PROTOCOL TITLE:
PRINCIPAL INVESTIGATOR:
SPONSOR/FUNDING SOURCE:
IRB Panel:
A
B
IRB REFERENCE #:
Meeting Date:
Reviewer Initials:
Primary Reviewer
When a clinical investigation involves the use of a drug or biologic other than the use of an
FDA approved, marketed drug/biologic in the course of medical practice, ONE of the
following conditions must be true:
 The drug or biologic must have an IND issued by the FDA
 An IND is not required – the investigation meets the criteria for exemption
Verification of IND Status
Does the drug or biologic have an IND issued by the FDA?
Yes
No
If yes, is the IND valid?
(The Investigator’s Brochure may not be used for this purpose).
Only one of the following must be “Yes”:
 The number is imprinted on the sponsor’s protocol.
 The number is noted in written correspondence from
the sponsor.
 The number is noted in written correspondence from
the FDA (required if the Investigator holds the IND)
.
Yes
No
Yes
No
Yes
No
Assessment of Requirement for an IND
For a clinical investigation involving a drug or biologic lawfully marketed in the
U.S., ALL of the following items must be found to be “Yes” for an IND to not be
required.
N/A
Is the investigation intended to be reported to FDA as a
well-controlled study in support of a new indication for use?
Yes
No
Is the investigation intended to be used to support any
other significant change in the labeling for the drug?
Yes
No
(rev. 7/4/11)
Is the investigation intended to support a significant change in the advertising for the lawfully
marketed drug product undergoing investigation?
Yes
No
Does the investigation 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 of the drug product?
Yes
No
Will the investigation be conducted in compliance with the
requirements for institutional review set forth in part 56 and with
the requirements for informed consent set forth in part 50?
Yes
No
Will the investigation be conducted in compliance with the
requirements of 21 CFR 312.7?
Yes
No
The investigation is not intended to invoke exception from informed
consent requirements for planned emergency use under 21 CFR 50.24.
Yes
No
For a clinical investigation involving a combination of drug products, this item
must be found to be “Yes” for an IND to not be required.
N/A
Each drug in the combination has been approved by the FDA for
marketing in the United States.
Yes
No
Note: Consultation with the FDA may be needed at the discretion of the IRB, for example, if
the IRB finds that statement 1.d. (above section) applies to the combination of products.
For a clinical investigation involving an in vitro diagnostic biological, ALL of the
following items must be found to be “Yes” for an IND to not be required.
N/A
The unlicensed biological product is limited to one or more of the
following in vitro diagnostic products: (a) blood grouping serum;
(b) reagent red blood cells; and (c) anti-human globulin;
Yes
No
It is intended to be used in a diagnostic procedure that confirms the
diagnosis made by another, medically established, diagnostic product
or procedure;
Yes
No
It is shipped in compliance with 312.160.
Yes
No
For a clinical investigation involving the use of a placebo:
An IND is not required for a clinical investigation involving use of a placebo if the research does not
otherwise require submission of an IND.
For an in vivo bioavailability or bioequivalence study in humans, ALL of the
following 6 items must be answered “No” for an IND to not be required.
N/A
[If any of the following is answered “Yes”, an IND is required.]
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The test product contains a new chemical entity** as defined in
21 CFR 314.108(a). [**a drug that contains no active moiety that
has been approved by FDA in any other application]
Yes
No
The study involves a radioactively labeled drug product;
Yes
No
The study involves a cytotoxic drug product.
Yes
No
The investigator will conduct a bioavailability or bioequivalence
study in humans using a drug product that contains an already
approved, non-new chemical entity and the study will involve a single
dose in normal subjects or patients where either the maximum single
or total daily dose exceeds that specified in the labeling of the drug
product that is the subject of an approved new drug application or
abbreviated new drug application;
Yes
No
The investigator will conduct a bioavailability or bioequivalence study
in humans using a drug product that contains an already approved, non-new
chemical entity and the study will involve a multiple-dose study in normal
subjects or patients where either the single or total daily dose exceeds that
specified in the labeling of the drug product that is the subject of an
approved new drug application or abbreviated new drug application;
Yes
No
The investigator will conduct a bioavailability or bioequivalence study
in humans using a drug product that contains an already approved,
non-new chemical entity and the study will involve a multiple-dose
study on an extended release product on which no single-dose study
has been completed.
Yes
No
For tests in vitro or in laboratory research animals, the following items must be
found to be “Yes” for an IND to not be required.
N/A
Is the drug/biologic is intended solely for tests in vitro or in laboratory
research animals?
Yes
No
Will the drug/biologic be shipped in accordance with FDA Regulations
for Drugs for investigational use in laboratory research animals or
in vitro tests (21 CFR 312.160)
Yes
No
FINAL IRB DETRMINATION
An IND is required for this investigation. Proper documentation has been received.
An IND is not required for this investigation (an FDA exemption letter has been
received).
The IRB feels an IND is not required for this investigation; however, the investigator
should formally request an exemption determination from the FDA.
Page 3 of 3 (rev. 7/4/11)