FORM 2: Drugs, Biologics, Dietary Supplements, and Foods
VERSION DATE
6/11/2015
PAGE
1 of 2
Submit this completed form (with original PI signature) to the IRB office (Box 817 or 15 Kneeland St, 1st floor)
IRB #:
PRINCIPAL INVESTIGATOR:
STUDY TITLE:
List all:
 Unapproved drugs/biologics being used in the protocol
 Approved drugs/ biologics whose use is specified in the protocol1
 Foods or dietary supplements whose use is specified in the protocol1
Tufts MC investigational
drug service (IDS)
If Tufts MC IDS will not store and
Generic Name:
Brand Name:
research pharmacy will
prepare drug, explain below:
store and prepare drug
Submit the
package insert or
investigator
brochure for each
listed drug
Under IND
Protocol is being conducted:
Submit evidence of
IND#(s)2
IND#(s)
Without IND
What is the basis for determining an IND is not required?3
Sponsor
Submit approved IND application(s) (Form 1571)
and FDA approval letter(s)) for IND#(s)
Investigator
Who holds the IND?
Other (Specify
)
__________________________________________________________
Signature of Principal Investigator
_____________________
Date
THE PRINCIPAL INVESTIGATOR IS TO RETAIN A COPY OF THIS COMPLETED FORM IN THE STUDY FILES
__________________________________
“Specified in the protocol” means that the protocol requires the one or more subjects to use the drug, biologic, dietary supplement, or food as part of study participation,
regardless of whether its’ use is standard of care. For example, if the protocol indicates that “subjects in group 1 will take 650 mg of aspirin in response to a headache” the use of
aspirin is specified by the protocol. If the protocol indicates that “subjects in group 1 may take 650 mg of aspirin in response to a headache” the use of aspirin is not specified by
the protocol.
2 Acceptable evidence includes: Sponsor protocol with the IND#, communication from the sponsor documenting the IND#, or FDA approval letter indicating IND#. IND numbers
may not be validated with an Investigator Brochure (which may serve multiple INDs).
3 Attach a separate sheet clarifying whether the sponsor determined that an IND is or is not required and the basis for the determination. If the sponsor has determined that an
IND is not required, provide a copy of any available supporting documentation (e.g., letter from the sponsor or FDA, other basis for that determination). Refer to the FDA
Guidance to determine whether an IND is needed.
Is this study subject to FDA
regulations under 21 CFR 312?
DRUGS*
*Isotopes not
addressed
Used as a
drug?
YES
Drug Definition:
“articles intended for the use in the
diagnosis, cure, mitigation,
treatment, or prevention of disease
or other condition…” and “articles
(other than food) intended to affect
the structure or any function of the
body of man or other animals.”
Includes dietary supplements
START
Must have an IND.
Contact the
sponsor or the
FDA.
YES
NO
NO
STOP. Does not
require review under
21 CFR 312.
DRUG?
Lawfully
marketed in the
US?
YES
BA/BE Study
only?
NO
IND exists?
In Vitro
NO
product?
YES
NO
YES
NO
Dietary
supplement, food,
cosmetic, or
biologic?
Exempt category
312.2b2(i) (see
responsibilities
below)
Revised
March 2014
YES
BA/BE Exemption
(see below)
YES
Contact sponsor or
FDA
No/Unsure
No/Unsure
Is it being used
in a diagnostic procedure that confirms
the diagnosis made by another medically
established diagnostic product or
procedure and is being shipped in
compliance with 312.160?
Dietary Supplement Definition: A product taken by mouth that
is intended to supplement the diet and that contain a dietary
ingredient. Can include vitamins, minerals, herbs, and other
botanicals, or amino acids. Includes concentrates, metabolites,
constituents, extracts, or combinations of the above ingredients.
Food definition: (1) articles used for food or drink for man or other
animals, (2) chewing gum, and (3) articles used for components of any
such article.
Cosmetic definition:“(1) articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or otherwise applied to the
human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and (2) articles intended for
use as a component of any such articles; except that such term shall not
include soap.
Biologic Definition: a virus, therapeutic serum, toxin, antitoxin,
vaccine, blood, blood component or derivative, allergenic
product, protein (except any chemically synthesized polypeptide),
or analogous product, or arsphenamine or derivative of
arsphenamine (or any other trivalent organic arsenic compound)
Bioavailability or Bioequivalence Studies (BA/BE)
- The drug product does not contain a new chemical entity (21 CFR
314.108), is not radioactively labeled, and is not cytotoxic.
- The dose (single dose or total daily dose) does not exceed the
dose specified in the labeling of the approved version of the drug
product.
Meets
exemption
criteria under
312.2b 1?
YES
IND #
(see responsibilities
below)
YES
IND Exempt (see
below)
Reference:
http://www.fda.gov/
downloads/Drugs/
Guidances/
UCM229175.pdf
Sep 2013
In Vitro diagnostic Biologic Product:
A. blood grouping serum
B. reagant red blood cells
C. anti-human globulin
Exemption Criteria 312.2 b 1: ALL conditions must be met:
1. No intent to report the investigation to FDA as a well-controlled study in support of a
new indication and no intent to use it to support any other significant change in the
labeling of the drug.
2. In the case of a prescription drug, the investigation is not intended to support a
significant change in the advertising of the drug.
3. The investigation does not involve a route of administration, dose, patient
population, or other factor that significantly increases the risk (or decreases the
acceptability of the risk) associated with the use of the drug.
4. The investigation is conducted in compliance with the requirements for review by an
IRB and with the requirements of informed consent.
5. The investigation is conducted in compliance with the requirements of 312.7 (the
investigation is not intended to promote or commercialize the drug product.)
Responsibilities if IND exists:
1. Document IND #
2. Ensure protocol contains FDA required monitoring plan
3. Ensure protocol addresses product labeling
4. Ensure 1571/1572 is completed and on file
5. IRB must review under 45 CFR 46 and 21 CFR 50,21 CFR 56, 21 CFR 312.
6. Start letter should clearly define reporting requirements
7. Best practice to have investigator with Good Clinical Practice (GCP) training
conduct the study.
8. IRB must review investigator brochure or package insert
Responsibilities if IND Exempt:
- IRB must review Investigator brochure or package insert
- IRB must concur with exemption determination by FDA. If no FDA
BA/BE Exemption
- The investigation is conducted in compliance with the requirements for determination, review sponsor determination and concur. If IRB
disagrees with sponsor determination must refer to FDA.
review by an IRB (21 CFR part 56) and with the requirements for
- IRB must review under 45 CFR 46, 21 CFR 50/56, 21 CFR 312.
informed consent (21 CFR part 50).
- The sponsor meets the requirements for retention of test article samples - Start letter should clearly define reporting requirements
- Best practice to have investigator with Good Clinical Practice
(21 CFR 320.31(d)(1)) and safety reporting (21 CFR 320.31(d)(3)).
(GCP) training conduct the study.