Download Drugs, Devices, and Biologics - Oregon State University Research

Human Research Protection Program
Institutional Review Board
Office of Research Integrity
B308 Kerr Administration Building, Corvallis, Oregon 97331-2140
(541) 737-8008
[email protected] | http://research.oregonstate.edu/irb
Pre-Review Supplemental Worksheet:
DRUGS, BIOLOGICS, FOODS, DIETARY SUPPLEMENTS, DEVICES, & BIOEQUIVALENCE
Study ID
Study Title
Principal Investigator
Submission Type
Pre-Reviewer
Date of Pre-Review
INTERVENTION TYPE
The study involves which of the following intervention(s):
☐ Drugs or Biologics
☐ Dietary Supplements
☐ Foods or related
☐ Devices
☐ Bioequivalence &
Bioavailability
Complete only the relevant sections below and the final determination section
FINAL DETERMINATION
YES
NO
a) Is the study FDA-regulated?
☐
☐
b) Does the study require an IND or IDE?
☐
☐
N/A
COMMENTS
Complete this section after completing the sections below.
(Note to Staff: if yes,
Database checkbox/FDA
Approval Notice)
☐
c) If “yes” what is the IND/IDE Status?
☐ IND # ______________
☐ IND Application Pending*
☐ Exempt from IND requirements
☐ IDE # _____________ (Significant Risk)
☐ IDE Application Pending*
☐ NSR Determination Recommended
☐ Exempt from IDE requirements
*IRB approval should not be granted until the IND or IDE #’s are received and validated.
1. DRUGS OR BIOLOGICS
YES
NO
a) Does the study involve administering a drug or biological
product to subjects?
If no, skip this section
If yes, the study is FDA-regulated:
☐
☐
☐
☐
i.
Is the drug or biological product already lawfully
marketed in the U.S.?
OSU IRB FWA000003920
1
N/A
COMMENTS
NOTE: If FDA-regulated, 21 CFR 50
& 56 apply.
HRPP Form | v. date May 2016
ii.
Is the route of administration, dosage level and
use in a subject population consistent with the
approved indications and labeling?
iii.
Is the study intended to support a significant
change in labeling, advertising, or to support a
new indication?
If “no” to (i) or (ii) and/or “yes” to (iii) - an IND may be
required. For more information see the IND Decision
☐
☐
☐
☐
☐
☐
☐
Rationale: ____________
☐
☐
☐
Number: ___________
Tree
If “yes” to (i) and (ii) and “no” to (iii) – the intervention
may be exempt from the IND requirements. For more
information see the IND Decision Tree
b) Is the intervention exempt from IND requirements?
c) If not exempt, has the FDA issued an IND number?
If no, IRB approval cannot be granted until the PI has
a valid IND number
i.
If no, is the IND application pending?
If no, the PI must submit an IND application to
the FDA
☐
☐
☐
ii.
If yes, has the validity of the IND number been
confirmed?
☐
☐
☐
d) Is there an adequate plan for the storage, dispensing,
labelling, handling, and disposal of all investigational and
FDA-approved drugs and/or biologics?
☐
☐
☐
2. FOODS
YES
NO
N/A
a) Does the study involve giving or providing food or a food
ingredient to subjects?
If no, skip this section.
☐
☐
b) Is there an adequate plan for the storage, preparation,
handling, and distribution of all foods?
☐
☐
c) Does the study adequately address the potential for
allergic reactions?
☐
☐
d) Does the study involve alcohol?
☐
☐
☐
☐
Acceptable documentation of the IND number includes:
Sponsor protocol imprinted with the IND number; written
communication from sponsor documenting the IND
number; or written communication from the FDA
documenting the IND number.
i.
Are subjects expectorating all alcohol?
May be eligible for exemption if it meet all criteria
under category 6
2
COMMENTS
☐
HRPP Form | v. June 2016
ii.
Are subjects ingesting alcohol?
If yes, may be expedited category 7 or Full Board
e) Does the study involve giving food or food ingredients as
an intervention (as opposed to compensation)?
If no, skip the rest of this section.
i.
Is the food used as only a food (i.e. primarily for
taste, aroma or nutritive value)?
ii.
Is the food store-bought or does it have a GMP or
USP/Food Grade certificate provided by the
manufacturer?
iii.
Is the food used for therapeutic purposes or to
cure, mitigate, or prevent disease (outside of
providing nutrition)?
iv.
Is the food used to affect or measure structure or
function of the body other than providing
nutrition
v.
Will the study be used to support a new health
claim related to the food?
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
Rationale: ___________
☐
☐
☐
NOTE: If FDA-regulated, 21 CFR 50
& 56 apply.
☐
☐
☐
Number: ___________
See also: 2015 FDA stay
related to health claims
If “yes” to (i) and (ii) and “no” to (iii), (iv) and (v) – The
food is not considered a drug and no IND would be
required. For more information see the FAQs on the IND
Decision Tree. Skip the rest of this section.
f)
If “no” to (i) or (ii) and/or “yes” to (iii), (iv) or (v) – The
food may be considered a drug and an IND may be
required. For more information see the FAQs on the IND
Decision Tree
Is the food being used as a drug?
i.
Is the food already lawfully marketed (as a drug)
in the U.S.?
ii.
Is the route of administration, dosage level and in
a subject population consistent with the approved
indications and labeling?
iii.
Is the study intended to support a significant
change in labeling, advertising, or to support a
new indication (such as a health claim)?
If “no” to (i) or (ii) and/or “yes” to (iii) - an IND may be
required. For more information see the IND Decision Tree
If “yes” to (i) and (ii) and “no” to (iii) – the intervention
may be exempt from the IND requirements. For more
information see the IND Decision Tree
g) Is the intervention exempt from IND requirements?
h) Is an IND needed for the drug/food?
If yes, the study is FDA-regulated
i.
If yes, has the FDA issued an IND number?
3
☐
HRPP Form | v. June 2016
If no, IRB approval cannot be granted until the PI
has a valid IND number
ii.
i. If no, is the IND application pending?
If no, the PI must submit an IND
application to the FDA
Has the validity of the IND number been
confirmed?
☐
☐
☐
☐
☐
☐
YES
NO
N/A
☐
☐
Acceptable documentation of the IND number includes:
Sponsor protocol imprinted with the IND number; written
communication from sponsor documenting the IND
number; or written communication from the FDA
documenting the IND number.
3. DIETARY SUPPLEMENTS
a) Does the study involve administering dietary supplements
to subjects?
If no, skip this section.
i.
Is the dietary supplement being used for
therapeutic purposes or to cure, mitigate, or
prevent disease?
☐
☐
ii.
Is the dietary supplement being used to affect
structure or function of the body other than
providing nutrients?
Will the study be used to support a new health
claim related to the dietary supplement?
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
iii.
COMMENTS
See also: 2015 FDA stay
related to health claims
If “no” to (i), (ii) and (iii) – The dietary supplement is not
considered a drug and no IND would be required. For
more information see the FAQs on the IND Decision Tree.
Skip to 3e.
If “yes” to (i), (ii) or (iii) – The dietary supplement may be
considered a drug and an IND may be required. For more
information see the FAQs on the IND Decision Tree
b) Is the dietary supplement being used as a drug?
i.
Is the dietary supplement already lawfully
marketed (as a drug) in the U.S.?
ii.
Is the route of administration, dosage level and
use in a subject population consistent with the
approved indications and labeling?
iii.
Is the study intended to support a significant
change in labeling, advertising, or to support a
new indication?
If “no” to (i) or (ii) and/or “yes” to (iii) - an IND may be
required. For more information see the IND Decision Tree
4
☐
HRPP Form | v. June 2016
If “yes” to (i) and (ii) and “no” to (iii) – the intervention
may be exempt from the IND requirements. For more
information see the IND Decision Tree
c) Is the intervention exempt from IND requirements?
☐
☐
☐
Rationale: __________
☐
☐
☐
NOTE: If FDA-regulated, 21 CFR 50
& 56 apply.
If yes, has the FDA issued an IND number?
If no, IRB approval cannot be granted until the PI
has a valid IND number
☐
☐
☐
Number: ___________
i. If no, is the IND application pending?
If no, the PI must submit an IND
application to the FDA
Has the validity of the IND number been
confirmed?
☐
☐
☐
☐
☐
☐
e) Is there an adequate plan for the storage, dispensing,
labeling, handling, and disposal of all dietary
supplements?
4. DEVICES
☐
☐
YES
NO
a) Does the study involve a medical device?
Refer to the “Is it a Medical Device” decision tree.
If “no”, skip this section.
b) Does the study collect safety or efficacy data related to
the medical device?
If “no”, it is not a clinical investigation of a device, and an
IDE is not required. Skip to 4h.
If “yes”, even if exempt from IDE requirements, the study
is FDA-regulated.
c) Is the device exempt from IDE requirements?
Refer to the “Is my medical device exempt” decision tree.
If the intervention is not exempt, an IDE is required.
☐
☐
☐
☐
NOTE: If FDA-regulated, 21 CFR 50
& 56 apply.
☐
☐
Rationale: ____________
d) Is the device an in vitro diagnostic (IVD) device?
☐
☐
d) Is an IND needed for the drug/dietary supplement?
If yes, the study is FDA-regulated
iii.
iv.
Acceptable documentation of the IND number includes:
Sponsor protocol imprinted with the IND number; written
communication from sponsor documenting the IND
number; or written communication from the FDA
documenting the IND number.
If “yes” and exempt from IDE requirements, consent can
be waived if all of the following criteria are met:
i.
Specimens are left over from routine clinical care
or a specimen repository or are leftover
specimens that were previously collected for
other research purposes.
ii.
Identity of the individual from whom the
specimen was originally obtained is not readily
5
N/A
COMMENTS
For more information, see:
FDA Guidance for informed
consent for IVD device
studies using leftover
specimens that are not
individually identifiable
HRPP Form | v. June 2016
ascertainable (deidentified or coded with an
agreement)
iii.
Researchers are not otherwise involved with the
subjects’ clinical care
iv.
Test results will not be reported to subjects’
health care providers.
If “no” to IVD device, or device is not exempt from IDE
requirements, or criteria above are not met, consent is
required (even if only deidentified specimen will be
used).
e) Are the consent procedures in compliance with FDA
requirements?
If exempt from IDE requirements, skip to 4h.
f) If the device is NOT exempt, indicate the risk level:
Refer to “Significant risk versus nonsignificant risk device”
decision tree.
☐ Non- Significant Risk (NSR) device
Investigator should provide documentation from
the sponsor, if sponsored. If no sponsor, the
determination must be made by the IRB at a
convened meeting.
☐ Significant Risk (SR) device
IDE is required.
g) Is there an IDE for the device?
☐
☐
☐
Risk Determination
Rationale: _____________
☐
☐
☐
If “yes”, has the validity of the IDE number been
confirmed?
Acceptable documentation of the IDE number includes:
Sponsor protocol imprinted with the IDE number; written
communication from sponsor documenting the IDE
number; or written communication from the FDA
documenting the IDE number.
h) Is there an adequate plan for the storage, dispensing,
labeling, handling, and disposal of all investigational
and/or FDA-approved devices?
☐
☐
☐
☐
☐
☐
5. BIOEQUIVALENCE & BIOAVAILABILITY
YES
NO
N/A
a) Does the study involve bioavailability or bioequivalence ?
☐
☐
b) Is the intervention exempt from IND requirements?
Refer to IND decision tree for additional information.
f) Is an IND needed for the drug product?
If yes, the study is FDA-regulated
g) If non-exempt, has the FDA issued an IND number?
☐
☐
☐
☐
☐
☐
NOTE: If FDA-regulated, 21 CFR 50
& 56 apply.
☐
☐
☐
Number: ___________
☐
☐
☐
i.
i.
Has the validity of the IND number been
confirmed?
Number: _____________
COMMENTS
Acceptable documentation of the IND number includes:
Sponsor protocol imprinted with the IND number; written
communication from sponsor documenting the IND
6
HRPP Form | v. June 2016
number; or written communication from the FDA
documenting the IND number.
h) Is there an adequate plan for the storage, dispensing,
labeling, handling, and disposal of the drug product?
7
☐
☐
HRPP Form | v. June 2016