REVIEWER CHECKLIST

Investigational New Drug (IND) Application Determination

PROTOCOL TITLE:

Principal Investigator: IRB REFERENCE #:

SPONSOR/FUNDING SOURCE:

IRB Panel: A BMeeting 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?

(TheInvestigator’s Brochure may not be used for this purpose).

Only oneof the following must be “Yes”:

  • The number is imprinted on the sponsor’s protocol. Yes No
  • The number is noted in written correspondence from

the sponsor. Yes No

  • The number is noted in written correspondence from

the FDA (required if the Investigator holds the IND). 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

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 useunder 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, ALLof 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 notberequired. N/A

[If any of the following is answered “Yes”, an IND is required.]

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 doseexceeds 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 1 of 3 (rev. 7/4/11)