Are Human
SubjectsInvolved?
1
PHS Human Subjects andClinical Trials Information Form
R Series
Does the research
involve human
specimens and/or
data?
NOYES
YES
NO
Is the project Exempt
from Federal
regulations?
NO
Select
Exemption
Number
YES
FINISHED
Attach Other Requested Information
only per FOA instructions
Attach Other Requested Information
only per FOA instructions
Is study
Delayed Onset?
1
Response to "Are Human Subjects Involved?" must match the response on the R&R Other Project Information form.
2
A proposal may include both Delayed Onsets and Study Records. Complete the appropriate sections for each portion of the project.
3
See NIH definition of clinical trial:
https://grants.nih.gov/policy/clinical-trials/definition.htm
4
Multiple delayed onset studies may be combined in a single delayed onset record.
These guidelines are generally applicable to NIHR-series proposals. Please refer to the FOA for specific instructions.
Please refer to the NIH Application Guide Section G.500 for details on this form:
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
FINISHED
YES
Clinical Trial
Complete at least one
Study Record
Go to Table 3
NO
Non-Exempt Human
Subjects Research
Complete at least one
Study Record
Go to Table 2
Exempt Human
Subject Research
Complete at least one
Study Record
Go to Table 1
Attach
Explanation
At least one Delayed Onset and/or
Study Record is required.
2
Determine Study Conditions:
Is study exempt?
Enter study title, Y/N
clinical trial, attach
justification
4
YES
NO
YES
NO
Is study a
Clinical Trial?
3
Created By Theresa Couch, Last Updated 
Exempt Human Subjects Research
Section 1 Basic Information Required
1.1 Study Title Required
1.2 Exempt? YES
1.3 Exemption Number Required
1.4 Clinical Trial Questionnaire
At least one question NO
1.5 ClinicalTrials.gov Identifier
E4 ONLY
1
All other Exemptions
2
YES
Section 2 Study Population Characteristics Not Required Required
2.1 Conditions or Focus of Study
Required
2.2 Eligibility Criteria Required
2.3 Age Limits Required
2.4 Inclusion of Women, Minorities & Children Required
2.5 Recruitment and Retention Plan
Required
2.6 Recruitment Status Required
2.7 Study Timeline Required
2.8 Enrollment of First Subject Required
Inclusion Enrollment Report Not Required Required
1. Existing Dataset or Resource?
Required
2. Enrollment Location Type
Required
3. Enrollment Countries Optional
4. Enrollment Locations Optional
5. Comments
Optional
Planned Table
Required if not using an existing
dataset or resource
Cumulative Table
Required if using existing dataset
or resource
Section 3 Protection and Monitoring Plans Required Required
3.1 Protection of Human Subjects Required Required
3.2 Multisite Study? Required Required
IRB Plan
3.3 Data Safety Monitoring Plan Optional Optional
3.4 DSM Board? Optional Optional
3.5 Overall Structure of the Study Team Optional Optional
Study Record
→ 1.4.a "Does the Study Involve Human Participants?" should be answered YES
Expemption Number (1.3 above)
→ Select "N/A" for Exempt Studies
→ Type of location, not name
→ Autopoulates USA for domestic
→ Up to 20 reports per study record
→ Use dash+space for bulleted list
→ Up to 20 Entries
→ Should match selection on PHS Human Subjects and Clinical Trials Information form
TABLE 1
Section 4 Protocol Synopsis
Do Not Complete Do Not Complete
Section 5 Other Clincial Trial-related Attachments Do Not Complete Do Not Complete
↓ ↓
Finished.
Attach to PHS Human Subjects
and Clinical Trials Information
form.
Finished.
Attach to PHS Human Subjects
and Clinical Trials Information
form.
Please refer to the NIH Application Guide Section G.500 for details and content requirements:
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
2
Any exemption other than E4 only, or any combination of exemptions including E4.
1
Exemption 4 ONLY.
These guidelines are generally applicable to NIH R-series proposals. Please refer to the FOA for specific instructions.
Non-Exempt Human Subjects Research
Section 1 Basic Information Required
1.1 Study Title Required
1.2 Exempt? NO
1.3 Exemption Number
1.4 Clinical Trial Questionnaire
At least one question NO
1.5 ClinicalTrials.gov Identifier
Section 2 Study Population Characteristics Required
2.1 Conditions or Focus of Study
Required
2.2 Eligibility Criteria
Required
2.3 Age Limits
Required
2.4 Inclusion of Women, Minorities & Children Required
2.5 Recruitment and Retention Plan
Required
2.6 Recruitment Status
Required
2.7 Study Timeline Required
2.8 Enrollment of First Subject
Required
Inclusion Enrollment Report
Required
1. Existing Dataset or Resource? Required
2. Enrollment Location Type
Required
3. Enrollment Countries Optional
4. Enrollment Locations Optional
5. Comments Optional
Planned Table
Required if not using an existing
dataset or resource
Cumulative Table
Required if using existing dataset
or resource
Section 3 Protection and Monitoring Plans
Required
3.1 Protection of Human Subjects
Required
3.2 Multisite Study?
Required
IRB Plan Required if 3.2 = YES
3.3 Data Safety Monitoring Plan Optional
3.4 DSM Board? Optional
3.5 Overall Structure of the Study Team Optional
Study Record
TABLE 2
→ 1.4.a "Does the Study Involve Human Participants?" should be answered YES
→ If YES, contact IRB office to develop sIRB Plan ([email protected]u)
→ Type of location, not name
→ Autopoulates USA for domestic
→ Up to 20 reports per study record
→ Use dash+space for bulleted list
→ Up to 20 Entries
Section 4 Protocol Synopsis
Do Not Complete
Section 5 Other Clinical Trial-related Attachments
Do Not Complete
↓
Finished.
Attach to PHS Human Subjects
and Clinical Trials Information
form.
These guidelines are generally applicable to NIH R-series proposals. Please refer to the FOA for specific instructions.
Please refer to the NIH Application Guide Section G.500 for details and content requirements:
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
Clinical Trial
Section 1 Basic Information Required
1.1 Study Title Required
1.2 Exempt? NO
1.3 Exemption Number
1.4 Clinical Trial Questionnaire
All questions YES
1.5 ClinicalTrials.gov Identifier Optional
Section 2 Study Population Characteristics Required
2.1 Conditions or Focus of Study
Required
→ Up to 20 Entries
2.2 Eligibility Criteria Required
→ Use dash+space for bulleted list
2.3 Age Limits
Required
2.4 Inclusion of Women, Minorities & Children
Required
2.5 Recruitment and Retention Plan Required
2.6 Recruitment Status Required
2.7 Study Timeline
Required
2.8 Enrollment of First Subject
Required
Inclusion Enrollment Report
Required → Up to 20 reports per study record
1. Existing Dataset or Resource?
Required
2. Enrollment Location Type Required
3. Enrollment Countries
Optional → Autopoulates USA for domestic
4. Enrollment Locations
Optional → Type of location, not name
5. Comments Optional
Planned Table
Required if not using an existing
dataset or resource
Cumulative Table
Required if using existing
dataset or resource
Section 3 Protection and Monitoring Plans
Required
3.1 Protection of Human Subjects Required
3.2 Multisite Study? Required
IRB Plan Required if 3.2 = YES
3.3 Data Safety Monitoring Plan
Required
3.4 DSM Board?
Required
3.5 Overall Structure of the Study Team Required
Study Record
TABLE 3
→ If YES, contact IRB office to develop sIRB Plan
([email protected])
Section 4 Protocol Synopsis
Required
4.1 Brief Summary Required
4.2 Study Design
4.2.a. Narrative Study Description Required
4.2.b. Primary Purpose Required
4.2.c Interventions
Required → Up to 20 interventions
4.2.d Study Phase Required → Select Y/N NIH Phase III
4.2.e. Intervention Model Required
4.2.f. Masking Required → aka Blinding, if YES select type(s)
4.2.g. Allocation Required
4.3 Outcome Measures Required → At least 1 required; up to 50
4.4 Statistical Design and Power Required
4.5 Subject Participation Duration Required
4.6 Will the study use FDA-regulated intervention? Required → If YES, provide attachment
4.7 Dissemination Plan Required
Section 5 Other Clinical Trial-related Attachments
Only include per FOA
↓
Finished.
Attach to PHS Human Subjects
and Clinical Trials Information
form.
Please refer to the NIH Application Guide Section G.500 for details and content requirements:
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
These guidelines are generally applicable to NIH R-series proposals. Please refer to the FOA for specific instructions.
→ File name must be unique to the proposal if more than one study
record is included
PHS Human Subjects and Clinical Trials Information
OMB Number: 0925-0001
Expiration Date: 03/31/2020
Please complete the human subjects section of the Research & Related Other Project Information form prior to completing this form.
The following items are taken from the Research & Related Other Project Information form and displayed here for your reference. Any changes to these
fields must be made on the Research & Related Other Project Information form and may impact the data items you are required to complete on this form.
Are Human Subjects Involved?
Yes No
Is the Project Exempt from Federal regulations?
Yes No
Exemption number:
If No to Human Subjects
654321
Does the proposed research involve human specimens and/or data?
Yes No
If Yes, provide an explanation of why the application does not involve human subjects research.
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Skip the rest of the PHS Human Subjects and Clinical Trials Information Form.
If Yes to Human Subjects
78
Add a record for each proposed Human Subject Study by selecting ‘Add New Study’ or ‘Add New Delayed Onset Study’ as appropriate. Delayed onset
studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset
Studies. For delayed onset studies, you will provide the study name and a justification for omission of human subjects study information.
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Other Requested Information
Click here to extract the Human Subject Study Record Attachment
Study Record(s)
Attach human subject study records using unique filenames.
1) Please attach Human Subject Study 1
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Delayed Onset Study(ies)
Study Title
Anticipated
Clinical
Trial?
Justification
Add Attachment Delete Attachment View Attachment
Updated: December 12, 2018
FORMS-E Series
Page 11 of 37
Complete human subjects section of R&R Other Project Information form prior to completing this form.
Information populated
from R&R Other Project
Information form.
When human subjects is No,
applicants answer a single
question, provide associated
attachment (as applicable), and
are done with the form unless
instructed in announcement to
include Other Requested
Information attachment.
Cannot add a Delayed Onset Study if you
answer No to human subjects question on
R&R Other Project Information form.
Required if Yes to human
specimens/data question.
If Anticipated Clinical Trial box is checked, funding
opportunity announcement must allow clinical trials.
When multiple studies are included in the same delayed
onset record, select Yes if it is anticipated that any study
will be a clinical trial.
Only provide an Other Requested Information
attachment when specifically requested in the funding
opportunity announcement text or application guide.
Required and system enforced for each delayed
onset study. In addition to justification, must
include information regarding how the study will
comply with the NIH single Institutional Review
Board (sIRB) policy prior to initiating any multi-site
study, as well as, a plan for the dissemination of
NIH-funded clinical trial information.
Delayed onset does NOT apply to a study that can be described
but will not start immediately (i.e., delayed start). Multiple delayed
onset studies can be grouped in a single record.
Answer required and
system enforced when
human subjects is No.
Required and system enforced for each delayed
onset study. Up to 600 characters. Study title must
be unique within the application. First 150
characters of title will show in application bookmark.
OMB Number: 0925-0001
Expiration Date: 03/31/2020
Study Record: PHS Human Subjects and Clinical Trials Information
* Always required field
Section 1 - Basic Information
1.1. * Study Title (each study title must be unique)
1.2. * Is this Study Exempt from Federal Regulations?
Yes No
1.3. Exemption Number
654321 78
1.4. * Clinical Trial Questionnaire
If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.
Yes
No
Yes No
Yes No
1.4.a. Does the study involve human participants?
1.4.b. Are the participants prospectively assigned to an intervention?
1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?
1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
Yes No
1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable
Section 2 - Study Population Characteristics
2.1. Conditions or Focus of Study
2.2. Eligibility Criteria
2.3. Age Limits Minimum Age Maximum Age
2.4. Inclusion of Women, Minorities, and Children
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2.5. Recruitment and Retention Plan
Add Attachment View AttachmentDelete Attachment
2.6. Recruitment Status
2.7. Study Timeline
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Add Inclusion Enrollment Report
2.8. Enrollment of First Subject
Inclusion Enrollment Report(s)
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FORMS-E Series
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Cannot add a Study Record if you answer No to Human Subjects question on R&R Other Project Information form.
HS = Human Subjects
CT = Clinical Trials
Required and system enforced. Up to 600 characters. Study title must be unique within the application. First 150
characters of title will show in application bookmark.
Answer required and system enforced.
If Study Exempt is Yes, must provide
exemption number. Exemptions 7 and
8 can be used for due dates on/after
January 25, 2019.
Answers to questionnaire required and system enforced.
If four questions are
all Yes AND FOA
allows clinical trials,
then study will be
flagged as a Clinical
Trial (CT) study.*
Optional. Provide NCT# for this study, if available.
Newly proposed studies do not need to be entered in
ClinicalTrials.gov at time of application. If building on an
existing study, enter NCT# for ancillary study (if
available), not the parent study.
Required and system enforced unless study is exemption 4. Up to 20 conditions at 255 characters each.
Required and system enforced unless study is exemption 4 or otherwise noted in opportunity.
Age limits are required and system enforced unless study is exemption 4 or otherwise noted in opportunity.
Dropdown
Dropdown:
Inclusion Enrollment Reports required and
system enforced unless study is exemption
4 or otherwise noted in opportunity.
Date: MM/DD/YYYY.
Required and system enforced unless study is exemption
4, 1.4.a=No, or otherwise noted in opportunity.
Required and system enforced unless study is exemption 4.
* Fellowship (F) and Career Development (K) applications to FOAs that do not allow clinical trials cannot propose
independent clinical trial studies led by applicant PD/PI. However, proposing studies under the leadership of a
sponsor/mentor that allows for clinical trials research experience is encouraged. Answering Yes to all four Clinical
Trial Questionnaire questions will not flag the study as a clinical trial. These studies must include HS information, but
will receive a system error if information is included in study fields in sections 4 or 5 of form.
Dropdown
Dropdown
If "N/A (No Limit)"
selected, do not
provide
numerical min/
max age.
Required and system enforced unless study is exemption
4, 1.4.a=No, or otherwise noted in opportunity.
Required and system enforced unless study is exemption
4, 1.4.a=No, or otherwise noted in opportunity.
Required and system enforced
unless study is exemption 4,
1.4.a=No, or otherwise noted in
opportunity.
Up to 20 Inclusion Enrollment Reports can be added.
Inclusion Enrollment Report
1. * Using an Existing Dataset or Resource
Yes No
2. * Enrollment Location Type
ForeignDomestic
3. Enrollment Country(ies)
4. Enrollment Location(s)
5. Comments
Planned
Racial Categories
Ethnic Categories
Not Hispanic or Latino
Female Male
Hispanic or Latino
Female Male
Total
American Indian/
Alaska Native
0
Asian
0
Native Hawaiian or
Other Pacific Islander
0
Black or African
American
0
White
0
More than One Race
0
Total
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Updated: December 12, 2018
FORMS-E Series
Page 13 of 37
Answer required and system enforced.
Answer required and system enforced. Do not mix domestic and foreign
enrollment data on the same inclusion enrollment report.
Multi-select from list of countries.
Planned enrollment information is required and system enforced when answer to "Using an Existing
Dataset or Resource" question is No. System enforcement relaxed if Comment is provided.
Up to 500 characters.
Cumulative (Actual)
Racial Categories
Ethnic Categories
Not Hispanic or Latino
Female Male
Unknown/
Not
Reported
Hispanic or Latino
Female Male
Unknown/
Not
Reported
Unknown/Not Reported Ethnicity
Female Male
Unknown/
Not
Reported
Total
American Indian/
Alaska Native
0
Asian
0
Native Hawaiian or
Other Pacific Islander
0
Black or African
American
0
White
0
More than One Race
0
Unknown or Not
Reported
0
Total
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Report 1 of 1
Updated: December 12, 2018
FORMS-E Series
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Cumulative (Actual) enrollment information is required and system enforced when answer to "Using an
Existing Dataset or Resource" question is Yes. System enforcement relaxed if Comment is provided.
Section 3 - Protection and Monitoring Plans
3.1. Protection of Human Subjects
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3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
Yes No N/A
If yes, describe the single IRB plan
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3.3. Data and Safety Monitoring Plan
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3.4. Will a Data and Safety Monitoring Board be appointed for this study?
Yes No
3.5. Overall Structure of the Study Team
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Section 4 - Protocol Synopsis
4.1. Brief Summary
4.2. Study Design
4.2.a. Narrative Study Description
4.2.b. Primary Purpose
4.2.c. Interventions
Intervention Type
Name
Description
4.2.d. Study Phase
Is this an NIH-defined Phase III clinical trial?
Yes No
4.2.e. Intervention Model
4.2.f. Masking
Yes No
Participant Care Provider Investigator Outcomes Assessor
Updated: December 12, 2018
FORMS-E Series
Page 15 of 37
Required and system enforced.
Answer required and system enforced. "N/A" is only a valid option for fellowship, and career
development applications OR if study is exempt from federal regulations (i.e., Question 1.2a is Yes).
Required and system enforced if Yes. Can attach same plan
(unique filenames) in multiple studies.
Required and system enforced for CT study. Optional for HS study.
Answer required and system enforced for CT study unless
otherwise noted in opportunity. Optional for HS study.
Up to 5000 characters. Required and system enforced for CT studies unless otherwise
noted in opportunity.
Dropdown list: Treatment; Prevention; Diagnostics; Supportive Care; Screening;
Health Services Research; Basic Science; Device Feasibility; and Other
Dropdown list: Drug (including placebo); Device (including
sham); Biological/Vaccine; Procedure/Surgery; Radiation;
Behavioral (e.g., Psychotherapy, Lifestyle Counseling);
Genetic (including gene transfer, stem cell and recombinant
DNA); and Dietary Supplement (e.g., vitamins, minerals)
Dropdown list: Early Phase 1 (or Phase 0); Phase 1; Phase 1/2;
Phase 2; Phase 2/3; Phase 3; Phase 4; and Other
Dropdown list: Single Group; Parallel; Cross-Over;
Factorial; Sequential; and Other.
All Study Design fields (4.2.a thru 4.2.g) are required and system enforced for
CT studies unless otherwise noted in opportunity.
Up to 32,000 characters.
Up to 200 characters.
Up to 1,000 characters.
Up to 20 Interventions allowed.
If Masking is Yes, you
must select at least 1 of
the Participant/Care
Provider/Investigator/
Outcomes Assessor
check boxes.
Optional.
You are not allowed to complete fields in Section 4 (i.e., will receive system error) if FOA
does not allow clinical trials and/or you answered No to one of the Clinical Trial
Questionnaire questions in Section 1.
4.2.g. Allocation
4.3. Outcome Measures
Name
Type
Time Frame
Brief Description
4.4. Statistical Design and Power
Add Attachment View AttachmentDelete Attachment
4.5. Subject Participation Duration
4.6. Will the study use an FDA-regulated intervention?
Yes No
4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational
Device Exemption (IDE) status
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4.7. Dissemination Plan
Add Attachment View AttachmentDelete Attachment
Section 5 - Other Clinical Trial-related Attachments
5.1. Other Clinical Trial-related Attachments
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Updated: December 12, 2018
FORMS-E Series
Page 16 of 37
Dropdown list: N/A; Randomized; and Non-randomized
At least one Outcome Measure required and system enforced for CT studies unless
otherwise noted in opportunity. Up to 50 Outcome Measures allowed.
Up to 255 characters.
Dropdown list: Primary; Secondary; and Other
Up to 255 characters.
Up to 999 characters.
Required and system enforced for CT study
unless otherwise noted in opportunity.
Up to 255 characters. Required and system enforced for CT studies
unless otherwise noted in opportunity.
Answer required and system enforced for CT study
unless otherwise noted in opportunity.
Required and system enforced if Yes.
Required and system enforced for CT study. Generally one Dissemination Plan per
application is sufficient. Can attach same plan (unique filenames) in multiple studies.
Form supports up to 10 attachments. Attachments only allowed for
CT studies. Only include attachments requested in opportunity.