Pre-Review Supplemental Worksheet:
DRUGS, BIOLOGICS, FOODS, DIETARY SUPPLEMENTS, DEVICES, BIOEQUIVALENCE
Study IDStudy 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 / ☐ Bioequivalence & Bioavailability
☐ Foods or related / ☐ Devices
Complete only the relevant sections below and the final determination section
FINAL DETERMINATION / YES / NO / N/A / COMMENTS
Complete this section after completing the sections below.
a)Is the study FDA-regulated? / ☐ / ☐ / (Note to Staff: if yes, Database checkbox/FDA Approval Notice)
b)Does the study require an IND or IDE? / ☐ / ☐ / ☐
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 / N/A / COMMENTS
a)Does the study involve administering a drug or biologicalproductto subjects?
If no, skip this section
If yes, the study is FDA-regulated: / ☐ / ☐ / NOTE: If FDA-regulated, 21 CFR 50 & 56 apply.
- Is the drug or biological product already lawfully marketed in the U.S.?
- Is the route of administration, dosage level and use in a subject population consistent with the approved indications and labeling?
- 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
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? / ☐ / ☐ / ☐ / Rationale: ______
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 / ☐ / ☐ / ☐ / Number: ______
- If no, is the IND application pending?
- 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 / COMMENTS
a)Does the study involve giving or providingfoodor a food ingredientto 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? / ☐ / ☐
- Are subjects expectorating all alcohol?
- 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. / ☐ / ☐
- Is the food used as only a food (i.e. primarily for taste, aroma or nutritive value)?
- Is the food store-bought or does it have aGMP or USP/Food Grade certificate provided by the manufacturer?
- Is the food used for therapeutic purposes or to cure, mitigate, or prevent disease (outside of providing nutrition)?
- Is the food used to affect or measure structure or function of the body other than providing nutrition
- Will the study be used to support a new health claim related to the food?
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 theIND Decision Tree. Skip the rest of this section.
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 theIND Decision Tree
f)Is the food being used as a drug? / ☐ / ☐ / ☐
- Is the food already lawfully marketed (as a drug) in the U.S.?
- Is the route of administration, dosage level and in a subject population consistent with the approved indications and labeling?
- 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? / ☐ / ☐ / ☐ / Rationale: ______
h)Is an IND needed for the drug/food?
If yes, the study is FDA-regulated / ☐ / ☐ / ☐ / NOTE: If FDA-regulated, 21 CFR 50 & 56 apply.
- If yes, has the FDA issued an IND number?
- If no, is the IND application pending?
- Has the validity of the IND number been confirmed?
3. DIETARY SUPPLEMENTS / YES / NO / N/A / COMMENTS
a)Does the study involve administering dietary supplements to subjects?
If no, skip this section. / ☐ / ☐
- Is the dietary supplement being used for therapeutic purposes or to cure, mitigate, or prevent disease?
- 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?
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 supplementbeing used as a drug? / ☐ / ☐ / ☐
- Is the dietary supplement already lawfully marketed (as a drug)in the U.S.?
- Is the route of administration, dosage level and use in a subject population consistent with the approved indications and labeling?
- 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
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: ______
d)Is an IND needed for the drug/dietary supplement?
If yes, the study is FDA-regulated / ☐ / ☐ / ☐ / NOTE: If FDA-regulated, 21 CFR 50 & 56 apply.
- If yes, has the FDA issued an IND number?
- If no, is the IND application pending?
- 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 / N/A / COMMENTS
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. / ☐ / ☐ / NOTE: If FDA-regulated, 21 CFR 50 & 56 apply.
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. / ☐ / ☐ / Rationale: ______
d)Is the device an in vitro diagnostic (IVD) device? / ☐ / ☐
If “yes” and exempt from IDE requirements, consent can be waived if all of the following criteria are met:
- Specimens are left over from routine clinical care or a specimen repository or are leftover specimens that were previously collected for other research purposes.
- Identity of the individual from whom the specimen was originally obtained is not readily ascertainable (deidentified or coded with an agreement)
- Researchers are not otherwise involved with the subjects’ clinical care
- 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. / Risk Determination Rationale: ______
g)Is there an IDE for the device? / ☐ / ☐ / ☐ / Number: ______
- If “yes”, has the validity of the IDE number been confirmed?
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 / COMMENTS
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 / ☐ / ☐ / ☐ / NOTE: If FDA-regulated, 21 CFR 50 & 56 apply.
g)If non-exempt, has the FDA issued an IND number? / ☐ / ☐ / ☐ / Number: ______
- Has the validity of the IND number been confirmed?
h)Is there an adequate plan for the storage, dispensing, labeling, handling, and disposal of the drug product? / ☐ / ☐
1HRPP Form | v. June 2016