PHS Human Subjects and Clinical Trials Information Instructions

G.500 - PHS Human Subjects and Clinical
Trials Information
The PHS Human Subjects and Clinical Trials Information
form is used to collect information on human subjects
research, clinical research, and/or clinical trials, including
study population characteristics, protection and
monitoring plans, and a protocol synopsis.
This form accommodates the full spectrum of all types of
clinical trials, including, but not limited to, behavioral,
exploratory/development, mechanistic, pilot/feasibility,
early phase, efficacy, effectiveness, group-randomized,
and others.
Read all the instructions in the Funding Opportunity
Announcement (FOA) before completing this form to
ensure your application meets all IC-specific criteria.
"Section II. Award Information" of the FOA will indicate
whether clinical trials are or are not allowed and
whether clinical trial research experience is or is not
allowed. The designation of your FOA will determine how to use these instructions, and
subsequently, how to fill out this form.
The PHS Human Subjects and Clinical Trials Information form, together with the rest of your
application, should include sufficient information for the evaluation of the project,
independent of any other documents (e.g., previous application). Be specific, describe each
study clearly, and avoid redundancies. Be especially careful to avoid redundancies with your
research strategy.
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Quick Links
PHS Human Subjects and Clinical Trials Information
Use of Human Specimens and/or Data
If No to Human Subjects
If Yes to Human Subjects
Other Requested Information
Study Record(s)
Delayed Onset Study(ies)
Study Record: PHS Human Subjects and Clinical Trials Information
Section 1 - Basic Information

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1.1 Study Title (each study title must be unique)
1.2 Is this Study Exempt from Federal Regulations?
1.3 Exemption Number
1.4 Clinical Trial Questionnaire
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
2.3.a Inclusion of Individuals Across the Lifespan
2.4 Inclusion of Women and Minorities
2.5 Recruitment and Retention Plan
2.6 Recruitment Status
2.7 Study Timeline
2.8 Enrollment of First Participant
2.9 Inclusion Enrollment Report(s)

Section 3 - Protection and Monitoring Plans
3.1 Protection of Human Subjects
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?
3.3 Data and Safety Monitoring Plan
3.4 Will a Data and Safety Monitoring Board be appointed for this study?
3.5 Overall Structure of the Study Team

Section 4 - Protocol Synopsis
4.1 Study Design
4.2 Outcome Measures
4.3 Statistical Design and Power
4.4 Subject Participation Duration
4.5 Will the study use an FDA-regulated intervention?
4.6 Dissemination Plan

Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments

Complete the PHS Human Subjects and Clinical Trials Information form after you have completed the
G.220 - R&R Other Project Information Form.

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This form accommodates the full spectrum of all types of clinical trials, including, but not limited to,
exploratory/development, mechanistic, pilot/feasibility, early phase, efficacy, effectiveness, grouprandomized, and others.
Who should use the PHS Human Subjects and Clinical Trials Information form:
The designation of your FOA will determine how to use these instructions, and subsequently, how to
fill out this form.
All applicants must use the PHS Human Subjects and Clinical Trials Information form regardless of your
answer to the question “Are human subjects involved?” on the G.220 - R&R Other Project Information
Form.
Additional Instructions for Training:
K12 and D43 applicants: If you are proposing any human subject studies in your
application, then at the time of application, you must use the PHS Human Subjects
and Clinical Trials Information form to submit delayed onset studies. Do not fill in
Study Records. Follow the instructions in your FOA. Post award, you will submit
Study Records if applicable.
All other Training applicants: This form is not applicable and will not be available
to you.
Note for studies involving only the secondary use of identifiable biospecimens or data: For
studies where the only involvement of human subjects is the use of identifiable biospecimens or data
originally collected for another purpose, complete the PHS Human Subjects and Clinical Trials
Information form with information specific to the current study and not the original collection unless
the information associated with the original collection is pertinent to the proposed study. If
information about the original collection is necessary, provide context and clearly distinguish between
the current study and historical information.
Using the PHS Human Subjects and Clinical Trials Information form:
Everyone must complete the "Use of Human Specimens and/or Data" section of the PHS Human
Subjects and Clinical Trials Information form. However, your answer to the “Are human subjects
involved?” question will determine which other sections of the PHS Human Subjects and Clinical Trials
Information form you must complete. Once you have completed the "Use of Human Specimens and/or
Data" section, follow instructions on the form that are specific to your answer to the "Are human
subjects involved?" question on the G.220 - R&R Other Project Information Form:
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if you answered "Yes" to the question "Are human subjects involved?" on the G.220 - R&R
Other Project Information Form, see the "If Yes to Human Subjects" section for instructions.
if you answered "No" to the question "Are human subjects involved?" on the G.220 - R&R
Other Project Information Form, see the "If No to Human Subjects" section for instructions.

The PHS Human Subjects and Clinical Trials Information form allows you to add Study Record(s) and/or
Delayed Onset Study(ies), as applicable.
Within each Study Record, you will add detailed information at the study level. Do not duplicate
studies within your application. Each study within the application should be unique and should have a
unique study title. Each Study Record is divided into numbered sections:

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Section 1 - Basic Information
Section 2 – Study Population Characteristics (includes Inclusion Enrollment Report)
Section 3 – Protection and Monitoring Plans
Section 4 – Protocol Synopsis
Section 5 – Other Clinical Trial-related Attachments

Note: The PHS Human Subjects and Clinical Trials Information form will capture detailed information at
the study level. Although you are encouraged to refer to information in the PHS Human Subjects and
Clinical Trials Information form in your discussion of the Research Strategy, do not duplicate
information between the Research Strategy attachment and the PHS Human Subjects and Clinical Trials
Information form.
For more information on what a “study” is for the purposes of the PHS Human Subjects and Clinical
Trials Information form, see the relevant FAQ on the Applying Electronically FAQ page.
The PHS Human Subjects and Clinical Trials Information form is dynamic and may eliminate sections
that are not relevant to your application. The dynamic form behavior may not be enabled on all
submission methods.
Note: Some fields in this form match fields within ClinicalTrials.gov and are identified as such within
these instructions. Additional information about the fields can be found on the ClinicalTrials.gov
Protocol Registration Data Element Definitions website.
Additional Instructions for Research:
R25 applicants who are proposing to provide clinical trial research experience
for their participants (i.e., participants will not be leading an independent
clinical trial): You will generally follow the standard instructions to complete the
PHS Human Subjects and Clinical Trials Information form, but follow relevant
Research instructions where they are given. Make sure you are applying to a FOA
that allows Clinical Trial Research Experience (this is noted in “Section II. Award
Information” of the FOA). Additionally, your mentor or co-mentor is required to
include a statement to document leadership of the clinical trial. The statement
must include the following:
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Source of funding;
ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable;
A description of how the mentor's expertise is appropriate to guide participants
in any proposed clinical trials research experience; and
A statement/attestation that the mentor will be responsible for the clinical trial.
o

o

The mentor must have primary responsibility for leading and overseeing the
trial and must describe how she/he will provide this oversight.
Include details on the specific roles/responsibilities of the mentor and
participants.

This statement must be included in the “Other Attachments” attachment in the
G.220 – R&R Other Project Information Form.

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R36 applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): You will generally follow the standard instructions to complete the
PHS Human Subjects and Clinical Trials Information form, but follow relevant
Research instructions where they are given. Make sure you are applying to a FOA
that allows Clinical Trial Research Experience (this is noted in “Section II. Award
Information” of the FOA). Additionally, your mentor or co-mentor is required to
include a statement to document leadership of the clinical trial. The statement
must include the following:






Source of funding;
ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable;
A description of how your expertise is appropriate to guide the applicant in any
proposed clinical trials research experience; and
A statement/attestation that the mentor will be responsible for the clinical trial.
o

o

The mentor must have primary responsibility for leading and overseeing the
trial and must describe how she/he will provide this oversight (be careful
not to overstate the candidate’s responsibilities).
Include details on the specific roles/responsibilities of the applicant and
mentor.

This statement must be included in the “Letters of Support” attachment in the
G.400 - PHS 398 Research Plan Form.
All other Research applicants: Follow the standard instructions to complete the
PHS Human Subjects and Clinical Trials Information form.
Additional Instructions for Career Development:
There are three primary situations by which K applicants can apply for human
subjects and/or clinical trial research.
Career Development Award (CDA) applicants who are not proposing a clinical
trial: Follow the standard instructions to complete the PHS Human Subjects and
Clinical Trials Information form.
CDA applicants who are proposing an independent clinical trial: Make sure you
are applying to a FOA that allows independent clinical trials (this is noted in
“Section II. Award Information” of the FOA). Follow the standard instructions to
complete the PHS Human Subjects and Clinical Trials Information form. (Note that
not every Study Record within your application has to be a clinical trial).
For more information on independent clinical trials, see:
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NIH Glossary definitions of Independent Clinical Trial and Ancillary Study
NIH Definition of Clinical Trial Case Studies
FAQ on Ancillary Studies
FAQs on the Human Subjects and Clinical Trials Information form, including a
specific FAQ on K99/R00 applications.

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

FAQs on Clinical Trial-specific FOAs, including a specific FAQ on K99/R00
applications.

CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): You will generally follow the standard instructions to complete the
PHS Human Subjects and Clinical Trials Information form, but follow relevant Career
Development instructions where they are given. Make sure you are applying to a
FOA that allows Clinical Trial Research Experience (this is noted in “Section II. Award
Information” of the FOA). Additionally, the mentor or co-mentor is required to
include a statement to document leadership of the clinical trial. The statement
must include the following:

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

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Source of funding;
ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable;
A description of how your expertise is appropriate to guide the applicant in any
proposed clinical trials research experience; and
A statement/attestation that the mentor will be responsible for the clinical trial.
o

o

The mentor must have primary responsibility for leading and overseeing the
trial and must describe how she/he will provide this oversight (be careful
not to overstate the candidate’s responsibilities).
Include details on the specific roles/responsibilities of the applicant and
mentor, keeping in mind that the terms of a CDA award do not always
permit the candidate to lead a clinical trial.

This statement must be included in the “Plans and Statements of Mentor and CoMentor(s)” attachment in the G.410 - PHS 398 Career Development Award
Supplemental Form.
Additional Instructions for Fellowship:
Fellowship applicants are permitted to conduct research involving human subjects;
however, they are NOT permitted to lead an independent clinical trial.
For more information, see:


FAQs on Clinical Trial-specific FOAs, especially the items related to Fellowship
awards:
o

FAQ about whether F awards allow clinical trials

o

FAQ about why Fellows are not allowed to lead an independent clinical trial

o

o

FAQ about whether there is a list of responsibilities that a Fellow must
assume with a clinical trial research experience
FAQ about who is responsible for the conduct of clinical trials proposed in a
Fellowship application

Fellowship applicants who are not proposing a clinical trial: Follow the
standard instructions to complete the PHS Human Subjects and Clinical Trials
Information form.

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Fellowship applicants who are proposing to gain clinical trial research
experience under a sponsor’s supervision (i.e., you will not be leading an
independent clinical trial): You will generally follow the standard instructions to
complete the PHS Human Subjects and Clinical Trials Information form, but follow
relevant Fellowship instructions where they are given. Make sure you are applying
to a FOA that allows Clinical Trial Research Experience (this is noted in “Section II.
Award Information” of the FOA). Additionally, the sponsor or co-sponsor is
required to include a statement to document leadership of the clinical trial. The
statement must include the following:
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Source of funding;
ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable;
A description of how the sponsor or co-sponsor’s expertise is appropriate to
guide the applicant in any proposed clinical trials research experience; and
A statement/attestation that the sponsor will be responsible for the clinical trial
o

o

The sponsor must have primary responsibility for leading and overseeing
the trial and must describe how she/he will provide this oversight (be
careful not to overstate the fellow’s responsibilities).
Include details on the specific roles/responsibilities of the fellow and
sponsor, keeping in mind that the terms of a fellowship award do not
permit the fellow to lead a clinical trial.

This statement must be included in the “Sponsor and Co-Sponsor Statements”
attachment of the G.430 - PHS Fellowship Supplemental Form.
Additional Instructions for Multi-project:
For multi-project applications with studies that are self-contained within a single
component:
Overall Component: Do not complete a Study Record.

Other Component: Complete a separate Study Record for each human subjects
study that is self-contained within a single component.
For multi-project applications with studies that span components:
Overall Component: Complete one Study Record for each study if it spans multiple
components. This Study Record must include sufficient information for all
components that are involved in the particular study. This might occur when an
application includes a data coordinating center or recruitment core, or when
participant assessments for one study are conducted across multiple components
(e.g., the study includes an imaging core and clinical site).
Applicants must follow all policies and requirements related to formatting, proprietary
information, human subjects, and clinical trials. See the following pages for more information:
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Format Attachments
Rules for Text Fields
NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information

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NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act
NIH's Human Subjects Research website
NIH's Clinical Trials website

Note: There are no page limits for any attachments in the PHS Human Subjects and Clinical Trials
Information form.

PHS Human Subjects and Clinical Trials
Information

Applicants must complete the human subjects questions on the G.220 - R&R Other Project
Information Form prior to completing this form.

Use of Human Specimens and/or Data
Regardless of your answer to the question “Are Human Subjects Involved?” on the G.220 R&R Other Project Information Form, answer the following question(s) about the use of
human specimens and/or human data.
Does any of the proposed research in the application involve human specimens and/or data?
Select “Yes” or “No” to indicate whether the proposed research involves human specimens
and/or data.

Note: Applications involving the use of human specimens or data may not be considered to be
research involving human subjects, depending on the details of the materials to be used.
Note: If you answered “No” to the “Does the proposed research involve human specimens
and/or data?” question, skip the rest of the PHS Human Subjects and Clinical Trials Information
form unless otherwise directed by your FOA.
Provide an explanation for any use of human specimens and/or data not considered to be human
subjects research.

If you answered “No” to the “Does any of the proposed research in the application involve human
specimens and/or data?” question, you do not need to attach an explanation here.

If you answered “Yes” to the “Does any of the proposed research in the application involve
human specimens and/or data?” question, you must provide an explanation for any use of
human specimens and/or data not considered to be human subjects research. To help determine
whether your research is classified as human subjects research, refer to the Research Involving
Private Information or Biological Specimens flowchart. For any human specimens and/or data
that is considered human subjects research, you will add a Study Record. Do not duplicate the
information in your explanation in any of your Study Records.
Attach the explanation as a PDF file. See NIH’s Format Attachments page.
This explanation should include:


information on who is providing the data/biological specimens and their role in the
proposed research;

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a description of the identifiers that will be associated with the human specimens and
data;
a list of who has access to subjects’ identities; and
information about the manner in which the privacy of research participants and
confidentiality of data will be protected.

Please complete the human subjects section of the Research & Related Other
Project Information form prior to completing this form.
Are Human Subjects Involved? Yes/No

This field is pre-populated from the G.220 - R&R Other Project Information Form. If the value in
this field appears to be incorrect, you may correct it by adjusting it on the G.220 - R&R Other
Project Information Form.

Is the Project Exempt from Federal regulations? Yes/No

This field is pre-populated from the G.220 - R&R Other Project Information Form. If the value in
this field appears to be incorrect, you may correct it by adjusting it on the G.220 - R&R Other
Project Information Form.

Exemption number: 1, 2, 3, 4, 5, 6, 7, 8

This field is pre-populated from the G.220 - R&R Other Project Information Form. If the value in
this field appears to be incorrect, you may correct it by adjusting it on the G.220 – R&R Other
Project Information Form.

Note: If you change your answer to the “Are Human Subjects Involved” question on the G.220 - R&R
Other Project Information Form after you have started entering information into the PHS Human
Subjects and Clinical Trials Information form, your data in the PHS Human Subjects and Clinical Trials
Information form may be lost.

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If No to Human Subjects
If you answered "No" to the question “Are Human Subjects Involved?” on the G.220 - R&R
Other Project Information Form, skip the rest of the PHS Human Subjects Clinical Trials
Information form unless otherwise directed by your FOA.

If Yes to Human Subjects
If you answered “Yes” to the question “Are Human Subjects Involved?” on the G.220 - R&R
Other Project Information Form, add a Study Record for each proposed study involving
human subjects by selecting “Add New Study” or “Add New Delayed Onset Study,” as
appropriate.

Other Requested Information
Who may provide Other Requested Information:

Follow the instructions below and any instructions in your FOA to determine whether you are
permitted to include the “Other Requested Information” attachment.
Format:

Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:

Content is limited to what is described in your FOA or in these instructions. Do not use the
“Other Requested Information” attachment to include any other information.
Renewal applications: When preparing a renewal (or resubmission of a renewal), you can
provide a list of ongoing studies or ClinicalTrials.gov identifiers (e.g., NCT87654321).
Additional Instructions for Multi-project:
For multi-project applications with studies that span components:
Overall Component: For each study that spans components, describe the
components involved with the study.

Other Components: Each component should include an attachment that indicates
that the details of the study are included in the Overall component within this
attachment.
For more information, see the “Where do I enter my human subjects study
information in my multi-project application” FAQ on the Applying Electronically
FAQ page.

Study Record(s)
Adding Study Record Attachment(s):

Add a study record for each proposed study involving human subjects. If specific plans for your
study involving human subjects can be described in the application but will not begin

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immediately (i.e., your study has a delayed start), you must add a Study Record for that study. If
your study anticipates involving human subjects within the period of award but specific plans
cannot be described in the application (i.e., delayed onset), see the instructions for Delayed
Onset Study(ies).
For all submission methods, the Study Record is used to collect human subjects study data. Note:
The steps to add a Study Record attachment(s) may vary with the submission method. For
example, from the ASSIST Human Subjects and Clinical Trials tab, use the ‘Add New Study’ button
to access the data entry screens to enter Study Record information directly into ASSIST. With
other submission methods, you may have to extract a blank copy of the Study Record, complete it
offline, and then attach it to your application.
Note on Grouping Studies into Study Records: While there may be more than one way to split
or group studies into Study Records, you are encouraged to group studies that use the same
human subjects population and same research protocols into a single Study Record, to the
extent that the information you provide is accurate and understandable to NIH staff and
reviewers.
If information in any attachment is identical across studies, include the complete information only
in the first Study Record for which the information is relevant. In the subsequent Study Records
for which the identical information is needed, upload an attachment that says, “See information
for attachment X in Study Record entitled [include study title]." No other information is needed in
the attachment. Do not submit attachments that are duplicated from one Study Record to
another. Note that you should not name Study Records by number. Examples of attachments that
may be identical across studies include, but are not limited to, the 3.1 Protection of Human
Subjects and 3.5 Overall Structure of the Study Team attachments.
See the NIH Glossary definitions of Study and Study Record.

The PHS Human Subjects and Clinical Trials Information form accommodates up to 150 separate
Study Records.
Format:

All attachments must be PDF files. If you extract a Study Record, it will already be in a fillable PDF
format. Please use this PDF file and do not alter the format of the Study Record file. Use unique
filenames for each human subject study record. The filename for each attachment within a study
must be unique within the application (i.e., do not use the same filename in multiple Study
Records).
Content:

Follow the instructions in the “Study Record: PHS Human Subjects and Clinical Trials Information”
section below.

Delayed Onset Study(ies)
Additional Instructions for Training:
K12 and D43 applicants: At the time of application, you must use the PHS Human
Subjects and Clinical Trials Information form to submit delayed onset studies if you
are proposing any human subject studies in your application. Follow the
instructions in your FOA. Post award, you will submit Study Records if applicable.

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If you anticipate conducting research involving human subjects but cannot describe the study at
the time of application (i.e., your study is a delayed onset human subject study), enter a Delayed
Onset Study Record as instructed below.
Generally, for any study that you include as a delayed onset study in this section, you will provide
a study title, indicate whether the study is anticipated to include a clinical trial, and include a
justification attachment. Since by definition, information for a delayed onset study is not available
at the time of application, you will not be given the option to complete a full Study Record for a
delayed onset study. For delayed onset studies, the Delayed Onset Study Record is sufficient.
Notes on delayed onset studies:




Delayed onset does NOT apply to a study that can be described but will not start
immediately (i.e., delayed start). Refer to the NIH Glossary definition of Delayed Onset
Study and Delayed Start.
If you anticipate multiple delayed onset studies, you can include them together in a
single Delayed Onset Study Record.

Study Title

This field is required.

The Study Title can have a maximum of 600 characters.
Enter a brief, unique title that describes the study the participants will be involved in. Each study
within your application must have a unique Study Title. The first 150 characters will display in the
application image bookmarks.
Note on multiple delayed onset studies: If you are including multiple delayed onset studies in
one delayed onset study entry, you may enter “Multiple Delayed Onset Studies” as the title of this
record.
Anticipated Clinical Trial?
This field is required.

Check this box if you anticipate that this study will be a clinical trial. For help determining whether
your study meets the definition of clinical trial, see the Clinical Trial Questionnaire below.
Read your FOA carefully to determine whether clinical trials are allowed in your application.
Note on multiple delayed onset studies: If you are including multiple delayed onset studies in
one delayed onset study entry, and you anticipate that any of these studies will be a clinical trial,
check the “Anticipated Clinical Trial?” checkbox.
Additional Instructions for Career Development:
Career Development Award (CDA) applicants who are not proposing a clinical
trial: Follow the standard instructions.
CDA applicants who are proposing an independent clinical trial: Follow the
standard instructions.

CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not check the “Anticipated Clinical Trial?” box.

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Additional Instructions for Fellowship:
Do not check the “Anticipated Clinical Trial?” box. Fellowship FOAs do not allow
independent clinical trials.
Justification Attachment

This attachment is required.
Attach the justification as a PDF file. See NIH’s Format Attachments page.
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All delayed onset studies must provide a justification explaining why human subjects
study information is not available at the time of application.
If NIH’s Single Institutional Review Board (sIRB) policy will apply to your study, this
justification must also include information regarding how the study will comply with the
policy. The applicant must provide a statement naming the sIRB of record in the Justin-time submission prior to award.
If NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information will apply to
your study, this justification must also include the dissemination plan.

Note on multiple delayed onset studies: If you are including more than one delayed onset
study in any given delayed onset study entry, address all the included studies in a single
justification attachment.

Study Record: PHS Human Subjects and Clinical
Trials Information
Section 1 - Basic Information
Who must complete “Section 1 – Basic Information:”
“Section 1 – Basic Information” is required for all studies involving human subjects.

1.1 Study Title (each study title must be unique)
The “Study Title” field is required.
The Study Title can have a maximum of 600 characters.
Enter a brief title that describes the study the participants will be involved in. If there is more than
one study (i.e., you are including more than one Study Record and/or delayed onset study in your
application), each one must have a unique study title. The first 150 characters will display in the
bookmarks of the application image.
Note: When registering a clinical trial in ClinicalTrials.gov, all study titles across your organization
must be unique.
Note: This field matches a ClinicalTrials.gov field (Official Title).

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1.2 Is this Study Exempt from Federal Regulations?
An answer to the “Is this Study Exempt from Federal Regulations?” question is required.
Indicate whether the study is exempt from Federal regulations for the Protection of Human
Subjects.
For more information, see the NIH's Definition of Human Subjects Research website.

1.3 Exemption Number
The “Exemption Number” field is required if you selected “Yes” to the “Is this Study Exempt from
Federal Regulations?” question.
Select the appropriate exemption number(s) for this particular study. Multiple selections are
permitted. Regardless of whether these exemptions may apply to you in the future, you must fill
out your application following the instructions below.
For more information:
The categories of research that qualify for exemption are defined in the Common Rule for the
Protection of Human Subjects. These regulations can be found at 45 CFR 46.
Need help determining the appropriate exemption number?



Refer to NIH's Human Subjects FAQs.
See the NIH's Human Subjects Frequently Asked Questions section on Exemptions.

The Office of Human Research Protections (OHRP) guidance states that appropriate use of
exemptions described in 45 CFR 46 should be determined by an authority independent from the
investigators (for more information, see OHRP's Frequently Asked Questions). Institutions often
designate their Institutional Review Board (IRB) to make this determination. Because NIH does
not require IRB approval at the time of application, the exemptions designated often represent
the opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is
evaluated during peer review.

1.4 Clinical Trial Questionnaire
The Clinical Trial Questionnaire is required.
Note for basic and mechanistic studies involving human participants: The NIH definition of a
clinical trial encompasses a broad range of studies, including studies using human participants
that aim to understand fundamental aspects of phenomena, the pathophysiology of a disease, or
the mechanism of action of an intervention. This includes many mechanistic studies and studies
submitted to Basic Experimental Studies with Humans FOAs.
Answer “Yes” or “No” to the following questions to determine whether this study involves a
clinical trial. Answer the following questions based only on the study you are describing in this
Study Record.
Note: The answer to question “1.4.a Does the study involve human participants?” will be prepopulated with “Yes” for all study records. You will not be able to change this answer.

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1.4.a. Does the study involve human participants? Yes/No
1.4.b. Are the participants prospectively assigned to an intervention? Yes/No
1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?
Yes/No
1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome? Yes/No

If you answered “Yes” to all the questions in the Clinical Trial Questionnaire, this study meets the
definition of a clinical trial.
Refer to the table below for information about what sections of this form are required, based on
your answers to Question 1.4 "Clinical Trial Questionnaire."

Form Section

If you answered "yes"

If you answered "no"

to all the questions in

to any of the questions

the Clinical Trial

in the Clinical Trial

Questionnaire

Questionnaire

Section 2 - Study Population
Characteristics

Required

Required

Section 3 - Protection and
Monitoring Plans

Required

Required

Section 4 - Protocol Synopsis

Required

Do not complete

Section 5 - Other Clinical Trialrelated Attachments

Required if specified in the
FOA

Do not complete

Additional Instructions for Research:
R25 applicants who are proposing to provide clinical trial research experience
for their participants (i.e., participants will not be leading an independent
clinical trial): Even if you answered “Yes” to all the questions in the Clinical Trial
Questionnaire, only certain fields of the PHS Human Subjects and Clinical Trials
Information form are required (and other fields are not allowed) because the study
is not an independent clinical trial. Do not provide information in “Section 4 –
Protocol Synopsis” or in “Section 5 – Other Clinical Trial-related Attachments” of the
Study Record. Inputting information into these sections will result in errors and will
prevent your application from being accepted.
R36 applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Even if you answered “Yes” to all the questions in the Clinical Trial
Questionnaire, only certain fields of the PHS Human Subjects and Clinical Trials
Information form are required (and other fields are not allowed) because the study
is not an independent clinical trial. Do not provide information in “Section 4 –

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Protocol Synopsis” or in “Section 5 – Other Clinical Trial-related Attachments” of the
Study Record. Inputting information into these sections will result in errors and will
prevent your application from being accepted.
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Even if you answered “Yes” to all the questions in the Clinical Trial
Questionnaire, only certain fields of the PHS Human Subjects and Clinical Trials
Information form are required (and other fields are not allowed) because the study
is not an independent clinical trial. Do not provide information in “Section 4 –
Protocol Synopsis” or in “Section 5 – Other Clinical Trial-related Attachments” of the
Study Record. Inputting information into these sections will result in errors and will
prevent your application from being accepted.
You will generally follow the standard instructions to complete the PHS Human
Subjects and Clinical Trials Information form, but follow relevant Career
Development instructions where they are given.
Additional Instructions for Fellowship:
Fellowship applicants who are proposing to gain clinical trial research
experience under a sponsor’s supervision (i.e., you will not be leading an
independent clinical trial): Even if you answered “Yes” to all the questions in the
Clinical Trial Questionnaire, only certain fields of the PHS Human Subjects and
Clinical Trials Information form are required (and other fields are not allowed)
because the study is not an independent clinical trial. Do not provide information in
“Section 4 – Protocol Synopsis” or in “Section 5 – Other Clinical Trial-related
Attachments” of the Study Record. Inputting information into these sections will
result in errors and will prevent your application from being accepted.
You will generally follow the standard instructions to complete the PHS Human
Subjects and Clinical Trials Information form, but follow relevant Fellowship
instructions where they are given.

For more information:








NIH Glossary’s definition of an NIH-defined clinical trial
NIH's Definition of a Clinical Trial page
NIH Definition of Clinical Trials Case Studies page
FAQs on the NIH Clinical Trial Definition
NIH’s decision tool will help determine whether your human subjects research study is
an NIH-defined clinical trial
Your study may also be subject to additional regulations. Read NIH’s Requirements for
Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov.

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1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if
applicable
If a clinical trial has already been entered into ClinicalTrials.gov, enter the ClinicalTrials.gov
identifier (e.g., NCT87654321) for this trial. Enter the identifier only if you are proposing to work
on that specific clinical trial. If you are only getting samples and/or data from a clinical trial that
has already been entered into ClinicalTrials.gov, do NOT enter the identifier.
If you are building on an existing study (e.g., ancillary study), enter the ClinicalTrials.gov identifier
only for the ancillary study (if registered separately), not the parent study.
Note: The number you enter in this field should match the ClinicalTrials.gov identifier assigned by
ClinicalTrials.gov.

Section 2 - Study Population Characteristics
Who must complete “Section 2 - Study Population Characteristics:”
All of “Section 2 – Study Population Characteristics” is required (see exceptions for Question 2.7 Study
Timeline and for Question 2.8 Enrollment of First Subject) for all human subjects studies unless the
following applies to you:


If you selected only Exemption 4 and no other exemptions on the "1.3 Exemption Number"
question, then “Section 2 – Study Population Characteristics” is not required.

2.1 Conditions or Focus of Study
At least 1 entry is required, and up to 20 entries are allowed (enter each entry on its own line).
Each entry is limited to 255 characters.
Identify the name(s) of the disease(s) or condition(s) you are studying, or the focus of the study. If
available, use appropriate descriptors from NLM's Medical Subject Headings (MeSH) so the
application can be categorized. Include an entry for each condition.
Note: This field matches a ClinicalTrials.gov field (Primary Disease or Condition Being Studied in
the Trial, or the Focus of the Study).

2.2 Eligibility Criteria
List the study’s inclusion and exclusion criteria. To provide a bulleted list, use a dash (or other
character) followed by a space (“- “) at the start of each bullet. Be sure to check the formatting in
the assembled application image. Further explanation or justification should be included in the
Recruitment and Retention plan.
Your text entry is limited to 15,000 characters (but typically needs only 500 characters).
Note: This field matches a ClinicalTrials.gov field (Eligibility Criteria).

For more information about formatting text entry fields, see NIH's Rules for Text Fields page and
the ClinicalTrials.gov's Protocol Registration and Results System User's Guide.

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2.3 Age Limits
Minimum Age

Enter the numerical value for the minimum age a potential participant can be to be eligible for the
study. Provide the relevant units of time (i.e., years, months, weeks, days, hours, or minutes). If
there is no lower limit or no lower limit is known, enter “N/A (No Limit)” and do not enter a unit of
time.
Maximum Age

Enter the numerical value for the maximum age a potential participant can be to be eligible for
the study. Provide the relevant units of time (i.e., years, months, weeks, days, hours, or minutes). If
there is no upper limit or no upper limit is known, enter “N/A (No Limit)” and do not enter a unit
of time.
Note: This field matches a ClinicalTrials.gov field (Age Limits).

2.3.a Inclusion of Individuals Across the Lifespan
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Discuss each of the points listed below. Also include any additional information requested in the
FOA.
You will also have to complete an Inclusion Enrollment Report (IER). Note that you may need to
include multiple IERs for each study. Refer to the instructions for the IER below for more
information.
Inclusion of Individuals Across the Lifespan

For the purposes of the Inclusion of Individuals Across the Lifespan, exclusion of any specific age
or age range group (e.g., children or older adults) should be justified in this section. In addition,
address the following points:




Individuals of all ages are expected to be included in all NIH-defined clinical research
unless there are scientific or ethical reasons not to include them. Discuss whether
individuals will be excluded based on age and provide a rationale for the minimum and
maximum age of study participants, if applicable. Additionally, if individuals will be
excluded based on age, provide a scientific or ethical rationale for their exclusion. See the
NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as
Participants in Research Involving Human Subjects for additional information about
circumstances that may justify the exclusion of individuals based on age.
Include a description of the expertise of the investigative team for working with
individuals of the ages included, the appropriateness of the available facilities to
accommodate individuals in the included age range, and how the age distribution of
participants will contribute to a meaningful analysis relative to the purpose of the study.

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When children are involved in research, the policies under HHS’ 45 CFR 46, Subpart D - Additional
Protections for Children Involved as Subjects in Research apply and must be addressed in the
Protection of Human Subjects attachment.
Existing Datasets or Resources. If you will use an existing dataset, resource, or samples that may
have been collected as part of a different study, you must address inclusion, following the
instructions above. Generally, you must provide details about the sex/gender, race, and ethnicity
of the existing dataset/resource and justify the details as appropriate to the scientific goals of the
proposed study.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Monitoring Inclusion When Working with Existing Datasets and/or
Resources.
For more information, see:






NIH Policy Implementation Page on Inclusion Across the Lifespan
Inclusion Across the Lifespan: Guidance for Applying the Policy infographic
NIH FAQs on Inclusion Across the Lifespan
HHS’ 45 CFR 46 Subpart D – Additional Protections for Children
NIH Grants Policy Statement, Section 4.1.15.7: Inclusion of Individuals Across the Lifespan
as Participants in Research Involving Human Subjects

2.4 Inclusion of Women and Minorities
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Discuss each of the points listed below and include any additional information requested in the
FOA.
You will also have to complete an Inclusion Enrollment Report (IER). Note that you may need to
include multiple IERs for each study. Refer to the instructions for the IER below for more
information.
Inclusion of Women and Minorities
Address the following points:







Describe the planned distribution of subjects by sex/gender, race, and ethnicity.
Describe the rationale for selection of sex/gender, racial, and ethnic group members in
terms of the scientific objectives and proposed study design. The description may
include, but is not limited to, information on the population characteristics of the
disease or condition under study.
Describe proposed outreach programs for recruiting sex/gender, racial, and ethnic
group members.
Inclusion and Excluded Groups: Provide a reason for limiting inclusion of any group by
sex/gender, race, and/or ethnicity. In general, the cost of recruiting certain groups

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and/or geographic location alone are not acceptable reasons for exclusion of particular
groups. See the Inclusion of Women and Minorities as Participants in Research Involving
Human Subjects - Policy Implementation Page for more information.
Existing Datasets or Resources. If you will use an existing dataset, resource, or samples that may
have been collected as part of a different study, you must address inclusion, following the
instructions above. Generally, you must provide details about the sex/gender, race, and ethnicity
of the existing dataset/resource and justify the details as appropriate to the scientific goals of the
proposed study.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Monitoring Inclusion When Working with Existing Datasets and/or
Resources.
NIH-Defined Phase III Clinical Trials. If the proposed research includes an NIH-Defined Phase
III Clinical Trial, the “Inclusion of Women and Minorities” attachment MUST address plans for how
sex/gender, race, and ethnicity will be taken into consideration in the design and valid analysis of
the trial. See the instructions for “Valid Analysis” and “Plans to test for Differences in Effect among
Sex/gender, Racial, and/or Ethnic Groups” below.
Additional information about valid analysis is available on the NIH Policy and Guidelines on The
Inclusion of Women and Minorities as Subjects in Clinical Research page.
Valid Analysis (for NIH-Defined Phase III Clinical Trials only):
Address the following issues for ensuring valid analyses:







Inclusive eligibility criteria – in general, the cost of recruiting certain groups and/or
geographic location alone are not acceptable reasons for exclusion of particular
groups;
Allocation of study participants of both sexes/genders and from different racial
and/or ethnic groups to the intervention and control groups by an unbiased process
such as randomization;
Unbiased evaluation of the outcome(s) of study participants; and
Use of unbiased statistical analyses and proper methods of inference to estimate and
compare the intervention effects by sex/gender, race, and/or ethnicity, particularly if
prior evidence strongly suggests that such differences exist.

Plan to Test for Differences in Effect among Sex/gender, Racial, and/or Ethnic Groups (for NIHDefined Phase III Clinical Trials only):
Applicants also should address whether they plan to test for differences in effect among
sex/gender, racial, and/or ethnic groups and why such testing is or is not appropriate.
This plan must include selection and discussion of one of the following analysis plans:




Plans to conduct analyses to detect significant differences in intervention effect
among sex/gender, racial, and/or ethnic subgroups when prior studies strongly
support these significant differences among one or more subgroups, or
Plans to include and analyze sex/gender, racial, and/or ethnic subgroups when prior
studies strongly support no significant differences in intervention effect between
subgroups. (Representation of sex/gender, racial, and ethnic groups is not required
as subject selection criteria, but inclusion is encouraged.), or

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

Plans to conduct valid analyses of the intervention effect in sex/gender, racial, and/or
ethnic subgroups (without requiring high statistical power for each subgroup) when
the prior studies neither support nor negate significant differences in intervention
effect among subgroups.

For more information, see:





NIH's Policy Implementation Page on the Inclusion of Women and Minorities
HHS’ 45 CFR 46 Subpart B – Additional Protections for Pregnant Women, Fetuses, and
Neonates
NIH Grants Policy Statement, Section 4.1.15.8: Inclusion of Women and Minorities as
Subjects in Clinical Research and Reporting Sex/Gender, Racial, and Ethnic Participation

2.5 Recruitment and Retention Plan
Who must complete the "Recruitment and Retention Plan" attachment:
The “Recruitment and Retention Plan” attachment is required unless the following applies to you:


You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.

Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Describe how you will recruit and retain participants in your study. You should address both
planned recruitment activities as well as proposed engagement strategies for retention.

2.6. Recruitment Status
Who must complete the "Recruitment Status" question:
The “Recruitment Status” question is required unless the following applies to you:


You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.

Content:
From the dropdown menu, select the "Recruitment Status" that best describes the proposed
study, based upon the status of the individual sites. If any facility in a multi-site study has an
individual site status of “recruiting,” then choose “recruiting” for this question. Only one selection
is allowed. Choose from the following options:





Not yet recruiting
Recruiting
Enrolling by invitation
Active, not recruiting

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




Completed
Suspended
Terminated (Halted Prematurely)
Withdrawn (No Participants Enrolled)

Note: This field matches a ClinicalTrials.gov field (Overall Recruitment Status).

2.7. Study Timeline
Who must complete the "Study Timeline" attachment:
The “Study Timeline” attachment is required if you answered "Yes" to all the questions in the
"Clinical Trial Questionnaire" (i.e., your study is a clinical trial).
The "Study Timeline" attachment is optional if either of the following apply to you:




You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.
You answered "No" to any of the questions in the "Clinical Trial Questionnaire" (i.e., your
study is not a clinical trial).

Format:
Attach this information as a PDF file. See NIH's Format Attachments page.
Content:
Provide a description or diagram describing the study timeline. The timeline should be general
(e.g., "one year after notice of award"), and should not include specific dates.
Note: Additional milestones or timelines may be requested as just-in-time information or postaward.

2.8. Enrollment of First Participant
Who must complete the "Enrollment of First Participant" question:
Do not complete this field if you will answer "Yes" to the question "Using an Existing Dataset or
Resource" in the Inclusion Enrollment Report.
The “Enrollment of First Participant” question is otherwise required unless the following applies
to you:


You selected only Exemption 4 and no other exemptions on the “1.3 Exemption
Number” question.

Content:
Enter the date (MM/DD/YYYY) of the enrollment of the first participant into the study. From the
dropdown menu, select whether this date is anticipated or actual.

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2.9. Inclusion Enrollment Report(s)
Who must complete the Inclusion Enrollment Report(s):
An Inclusion Enrollment Report is required for all human subjects studies unless, on Question 1.3
“Exemption Number,” you selected only Exemption 4 and no other exemptions.
Using the Inclusion Enrollment Report:
Each proposed study, unless it falls under Exemption 4, must contain at least one Inclusion Enrollment
Report (IER). However, more than one IER per study is allowed.
Once you have added an IER for a given study, you may edit, remove, or view it.
Note: You can add a maximum of 20 IERs per Study Record. These can be a combination of planned
and cumulative reports.
Multi-site studies: Generally, if the application includes a study recruiting subjects at more than one
site/location, investigators may create one IER or separate, multiple IERs to enable reporting by study
or by site, depending on the scientific goals of the study and whether monitoring of inclusion
enrollment would benefit from being combined or separated. At a minimum, participants enrolled at
non-U.S. sites must be reported separately from participants enrolled at U.S. sites, even if they are part
of the same study. Please review the FOA to determine whether there are any other specific
requirements about how to complete the IER.
Duplicative Inclusion Reports: It is important that the IER for a given study be associated with only
one application and be provided only once in a given application (e.g., do not submit the same IER on
both the data coordinating center and the research site). If submitting individual application(s) as part
of a network or set of linked applications, please provide the IER with the individual site applications
unless otherwise directed by the FOA.
Renewal applications: When preparing a renewal (or resubmission of a renewal), investigators should
provide a narrative description regarding the cumulative enrollment from the previous funding period
(s) as part of the progress report section of the research strategy attachment in the application. The
IER should NOT be used for this purpose. If a given study will continue with the same enrollment or
additional enrollment, or if new studies are proposed, provide a new IER for each as described in the
instructions below.
Resubmission applications: If IERs were provided in the initial submission application, and if those
studies will be part of the resubmission application, complete the IER and submit again with the
resubmission application, regardless of whether the enrollment has changed or not. Also, provide any
new (additional) IERs.
Revision applications: Provide an IER if new studies are planned as part of the Revision and they meet
the NIH definition for clinical research.
Additional Instructions for Multi-project:
For multi-project applications with studies that are self-contained within a
single component:
Other Component: Include the IER(s) with the component(s) that involves the
study(s), unless otherwise directed by the FOA.
For multi-project applications with studies that span components:

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Overall Component: Should the study span more than one component, include
the IER with the Study Record in the Overall Component and insert a comment in
the comment field of the IER to indicate what other components it is associated
with.
For more information:
Refer to the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects Policy Implementation Page.

1. Inclusion Enrollment Report Title
The “Inclusion Enrollment Report Title” field is required.
The “Inclusion Enrollment Report title can have a maximum of 600 characters.
Enter a unique title for each IER. The title should indicate specific criteria that uniquely identify
each report. If the Project Title is pre-populated, you may edit it so that each IER title is unique.

2. Using an Existing Dataset or Resource?
The “Using an Existing Dataset or Resource” question is required.
If the study involves analysis of an existing dataset or resource (e.g., biospecimens) only, answer
“Yes” to this question. If the study involves prospective recruitment or new contact with
participants answer “No” to this question. Use separate IERs for studies involving use of existing
datasets or resources only and for studies that involve prospective recruitment or new contact
with study participants.
For additional guidance on what is considered an existing dataset, refer to the NIH FAQs on
Monitoring Inclusion When Working with Existing Datasets and/or Resources.

3. Enrollment Location Type (Domestic/Foreign)
The “Enrollment Location Type” field is required.

Select whether the participants described in the IER are based at a U.S. (Domestic) or at a nonU.S. (Foreign) site. Participants at U.S. and non-U.S. sites must be reported separately (i.e., on
separate IERs), even if it is for the same study.
For additional guidance on how to complete the IER if you will be working with non-U.S.
populations, refer to these FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.

4. Enrollment Country(ies)
The “Enrollment Country(ies)” field is optional.
Indicate the country or countries in which participants will be enrolled. Multiple U.S. sites can be
reported together in one IER. Foreign countries can be reported together in one IER. However,
you must use separate IERs for U.S. and non-U.S. sites. You can add up to 200 countries per IER.

5. Enrollment Location(s)
The “Enrollment Location(s)” field is optional.
Indicate the type of enrollment location (e.g., hospital, university, or research center), not the
name of the enrollment location.

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Enrollment locations are typically where the research is conducted, and can be different from the
recruitment site.

6. Comments
Your comments are limited to 500 characters.
Enter information you wish to provide about this IER. This includes, but is not limited to,
addressing information about distinctive subpopulations if relevant to the scientific hypotheses
being studied. If inclusion monitoring is conducted on another study or NIH grant (e.g., data
coordinating center or research site), please indicate here.
Revision applications: If there are no updates to the IER(s) in your original grant application, do
not include an IER in your Revision application. Instead, provide a comment in this field to the
effect that previous IER(s) are still applicable. If you are revising the IER(s) in your original grant
application, provide a comment here to that effect.
Additional Instructions for Multi-project:
For multi-project applications with studies that span components:

Overall Component: Should the study span more than one component, include
the IER with the Study Record in the Overall Component and insert a comment
here in the comment field to indicate what other components it is associated with.

Planned
Who must complete planned enrollment tables:
All studies must enter planned enrollment counts unless your proposed study will use only an
existing dataset or resource. Planned enrollment generally means that individuals will be
recruited into the study and/or that individuals have already been recruited and continue to be
part of the study.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.
For more information on racial categories, see the NIH Glossary definition of Racial Categories.
For more information on ethnic categories, see the NIH Glossary definition of Ethnic Categories.
Racial Categories
American Indian/Alaska Native:
These fields are required.

Enter the expected number of females and males (in the respective fields) who are both American
Indian/Alaska Native and Not Hispanic or Latino. Enter the expected number of females and
males (in the respective fields) who are both American Indian/Alaska Native and Hispanic or
Latino.
Asian:

These fields are required.
Enter the expected number of females and males (in the respective fields) who are both Asian
and Not Hispanic or Latino. Enter the expected number of females and males (in the respective
fields) who are both Asian and Hispanic or Latino.

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Native Hawaiian or Other Pacific Islander:
These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Native
Hawaiian or Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of
females and males (in the respective fields) who are both Native Hawaiian or Other Pacific
Islander and Hispanic or Latino.
Black or African American:

These fields are required.
Enter the expected number of females and males (in the respective fields) who are both Black or
African American and Not Hispanic or Latino. Enter the expected number of females and males (in
the respective fields) who are both Black or African American and Hispanic or Latino.

White:

These fields are required.
Enter the expected number of females and males (in the respective fields) who are both White
and Not Hispanic or Latino. Enter the expected number of females and males (in the respective
fields) who are both White and Hispanic or Latino.

More than One Race:

These fields are required.
Enter the expected number of females and males (in the respective fields) who both identify with
more than one racial category and are Not Hispanic or Latino. Enter the expected number of
females and males (in the respective fields) who both identify with more than one racial category
and are Hispanic or Latino.

Total:

The total fields at the bottom will be automatically calculated and reflect the totals of all racial
categories for females, males, and individuals of unknown/not reported sex/gender who are Not
Hispanic or Latino and of all racial categories for females, males, and individuals of unknown/not
reported sex/gender who are Hispanic or Latino. The “Total” fields in the right column will be
automatically calculated to total all individuals.

Cumulative (Actual)
Who must complete cumulative (actual) enrollment tables:
You must enter cumulative enrollment counts if your proposed study will use an existing dataset
or resource.
For more information about what is considered an existing dataset or resource for inclusion
policy, see the NIH FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.
For more information on racial categories, see the NIH Glossary definition of Racial Categories.
For more information on ethnic categories, see the NIH Glossary definition of Ethnic Categories.
Racial Categories
American Indian/Alaska Native:
These fields are required.

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Enter the number of females and males (in the respective fields) who are both American
Indian/Alaska Native and Not Hispanic or Latino. Enter the number of females and males (in the
respective fields) who are both American Indian/Alaska Native and Hispanic or Latino. Use the
“Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity is unknown).
Asian:

These fields are required.

Enter the number of females and males (in the respective fields) who are both Asian and Not
Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who
are both Asian and Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e.,
race and/or ethnicity is unknown).
Native Hawaiian or Other Pacific Islander:
These fields are required.

Enter the number of females and males (in the respective fields) who are both Native Hawaiian or
Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of females and
males (in the respective fields) who are both Native Hawaiian or Other Pacific Islander and
Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity
is unknown).
Black or African American:

These fields are required.

Enter the number of females and males (in the respective fields) who are both Black or African
American and Not Hispanic or Latino. Enter the expected number of females and males (in the
respective fields) who are both Black or African American and Hispanic or Latino. Use the
“Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity is unknown).
White:

These fields are required.
Enter the number of females and males (in the respective fields) who are both White and Not
Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who
are both White and Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e.,
race and/or ethnicity is unknown).

More than One Race:

These fields are required.
Enter the number of females and males (in the respective fields) who both identify with more
than one racial category and are Not Hispanic or Latino. Enter the expected number of females
and males (in the respective fields) who both identify with more than one racial category and are
Hispanic or Latino. Use the “Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity
is unknown).

Unknown or Not Reported:

These fields are required.

Enter the number of females, males, and individuals of unknown/not reported sex/gender (in the
respective fields) whose race is unknown/not reported and who are Not Hispanic or Latino. Enter
the number of females, males, and individuals of unknown/not reported sex/gender (in the
respective fields) whose race is unknown/not reported and who are Hispanic or Latino. Enter the

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number of females, males, and individuals of unknown/not reported sex/gender (in the
respective fields) who are both of unknown/not reported race and of unknown/not reported
ethnicity. Use the “Unknown/Not Reported” fields as needed (i.e., race and/or ethnicity is
unknown).
Total:

The total fields at the bottom will be automatically calculated and reflect the totals of all racial
categories for females, males, and individuals of unknown/not reported sex/gender who are Not
Hispanic or Latino and of all racial categories for females, males, and individuals of unknown/not
reported sex/gender who are Hispanic or Latino. Use the “Unknown/Not Reported” fields as
needed (i.e., race and/or ethnicity is unknown). The “Total” fields in the right column will be
automatically calculated to total all individuals.

Section 3 – Protection And Monitoring Plans
Who must complete “Section 3 – Protection and Monitoring Plans:”
All of “Section 3 – Protection and Monitoring Plans” is required for all studies involving human
subjects, unless otherwise noted.

3.1 Protection of Human Subjects
The “Protection of Human Subjects” attachment is required.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Do not use the “Protection of Human Subjects” attachment to circumvent the page limits of the
Research Strategy.
For Human Subjects Research Claiming Exemptions: If you are claiming that your human
subjects research falls under any exemptions, justify why the research meets the criteria for the
exemption(s) that you have claimed. This justification should explain how the proposed research
meets the criteria for the exemption claimed. Do not merely repeat the criteria or definitions
themselves.
For Studies that involve Non-Exempt Human Subjects Research: For any proposed nonexempt study involving human subjects, NIH requires a Protection of Human Subjects
attachment that is commensurate with the risks of the study, its size, and its complexity. Organize
your attachment into four sections, following the headings and specified order below, and
discuss each of the points listed below. Start each section with the appropriate section heading –
Risks to Human Subjects, Adequacy of Protection Against Risks, Potential Benefits of the
Proposed Research to Research Participants and Others, and Importance of the Knowledge to be
Gained. Also include any additional information requested in the FOA.

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1. Risks to Human Subjects
a. Human Subjects Involvement, Characteristics, and Design





Briefly describe the overall study design.
Describe the subject population(s) to be included in the study; the procedures for assignment
to a study group, if relevant; and the anticipated numbers of subjects for each study group.
List any collaborating sites where human subjects research will be performed, and describe
the role of those sites and collaborating investigators in performing the proposed research.

b. Study Procedures, Materials, and Potential Risks








Describe all planned research procedures (interventions and interactions) involving study
subjects; how research material, including biospecimens, data, and/or records, will be
obtained; and whether any private identifiable information will be collected in the proposed
research project.
For studies that will include the use of previously collected biospecimens, data or records,
describe the source of these materials, whether these can be linked with living individuals,
and who will be able to link the materials.
Describe all the potential risks to subjects associated with each study intervention, procedure
or interaction, including physical, psychological, social, cultural, financial, and legal risks; risks
to privacy and/or confidentiality; or other risks. Discuss the risk level and the likely impact to
subjects.
Where appropriate, describe alternative treatments and procedures, including their risks and
potential benefits. When alternative treatments or procedures are possible, make the
rationale for the proposed approach clear.

2. Adequacy of Protection Against Risks
a. Informed Consent and Assent


Describe the process for obtaining informed consent. Include a description of the
circumstances under which consent will be sought and obtained, who will seek it, the nature
of the information to be provided to prospective subjects, and the method of documenting
consent. When appropriate, describe how potential adult subjects’ capacity to consent will be
determined and the plans for obtaining consent from a legally authorized representative for
adult subjects not able to consent.
o



For research involving children: If the proposed studies will include children, describe
the process for meeting HHS regulatory requirements for parental permission and child
assent (45 CFR 46.408). See the HHS page on Research with Children FAQs and the NIH
page on Requirements for Child Assent and Parent/Guardian Permission.

If a waiver of some or all of the elements of informed consent will be sought, provide
justification for the waiver. Do not submit informed consent document(s) with your
application unless you are requested to do so.

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b. Protections Against Risk






Describe planned strategies for protecting against or minimizing all potential risks identified,
including strategies to manage and protect the privacy of participants and confidentiality of
research data.
Where appropriate, discuss plans for ensuring necessary medical or professional intervention
in the event of adverse effects on participants.
Describe plans for handling incidental findings, such as those from research imaging,
screening tests, or paternity tests.

c. Vulnerable Subjects, if relevant to your study
Explain the rationale for the involvement of special vulnerable populations, such as fetuses, neonates,
pregnant women, children, prisoners, institutionalized individuals, or others who may be considered
vulnerable populations. 'Prisoners' includes all subjects involuntarily incarcerated (for example, in
detention centers).
Pregnant Women, Fetuses, and Neonates or Children
If the study involves vulnerable subjects subject to additional protections under Subparts B and D
(pregnant women, fetuses, and neonates or children), provide a clear description of the risk level and
additional protections necessary to meet the HHS regulatory requirements.




HHS’ Subpart B - Additional Protections for Pregnant Women, Fetuses, and Neonates
HHS’ Subpart D - Additional Protections for Children
OHRP Guidance on Subpart D Special Protections for Children as Research Subjects and the
HHS 407 Review Process

Prisoners
If the study involves vulnerable subjects subject to additional protections under Subpart C (prisoners),
describe how proposed research meets the additional regulatory requirements, protections, and
plans to obtain OHRP certification for the involvement of prisoners in research.
Refer to HHS regulations, and OHRP guidance:



HHS’ Subpart C - Additional Protections Pertaining to Prisoners as Subjects
OHRP Subpart C Guidance on Involvement of Prisoners in Research

3. Potential Benefits of the Proposed Research to Research Participants and Others





Discuss the potential benefits of the research to research participants and others.
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to
research participants and others.
Note: Financial compensation of subjects should not be presented as a benefit of
participation in research.

4. Importance of the Knowledge to be Gained



Discuss the importance of the knowledge to be gained as a result of the proposed research.
Discuss why the risks to subjects are reasonable in relation to the importance of the
knowledge that reasonably may be expected to result.

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For more information:


Refer to the NIH’s Human Subjects Research website.

3.2 Is this a multi-site study that will use the same protocol to conduct nonexempt human subjects research at more than one domestic site?
Select "Yes" or "No" to indicate whether this is a multi-site study that will use the same protocol
to conduct non-exempt human subjects research at more than one domestic site.
Select “N/A” only if any of the following apply (do not select “N/A” if none of the following apply):







You answered “Yes” to “Question 1.2 Is this Study Exempt from Federal Regulations?
(Yes/No)”
You are a training grantapplicant
Multi-site studies for which more than single IRB review is required by law (including tribal law passed by
the official governing body of an American Indian or Alaska Native tribe).
Foreign sites participating in NIH-funded, multi-site studies

Applicants who check “Yes” are expected to use a single Institutional Review Board (sIRB) to
conduct the ethical review required by HHS regulations for the Protections of Human Subjects
Research unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation,
or policy.
Note: For Studies with Legal- or Regulatory -based Claims for Exception as described by the
sIRB Policy: Although applicants check “N/A” to 3.2, a sIRB attachment must be provided. See
instructions in content below.
Note: The NIH sIRB policy applies to participating domestic sites. Foreign sites participating in
NIH-funded, multi-site studies are not expected to follow this policy.

For more information:
Additional Instructions for Training:
Check “N/A,” as the sIRB policy does not apply to training awards.






HHS regulations and requirements for the Protections of Human Subjects can be found
at 45 CFR 46.
See NIH’s Single IRB Policy for Multi-site Research for more information.
See the FAQ about answering “No” for this question on the Applying Electronically FAQ
page.

If yes, describe the single IRB plan
Format:
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Attach this information as a PDF file. See NIH’s Format Attachments page.
You must include an sIRB attachment for each study within your application. All filenames within
your application must be unique.
Content:
Provide a statement that the sIRB plan is not applicable. This statement will be submitted, in lieu of a sIRB plan,
which is no longer required. The applicant must provide a statement naming the sIRB of record in the Just-intime submission prior to award.
For Studies with Legal-, Regulatory-, or Policy-based Claims for Exception as described by
the sIRB Policy: Indicate that review by an sIRB will not be possible for all or some sites (specify
which sites) because local IRB review is required by an existing federal/state/tribal law or policy.
Include a specific citation to the relevant law, policy, or regulation.
For more information:







NIH's Single IRB Policy for Multi-site Research page
NIH's FAQs on Single IRB Policy for Multi-site Research
NIH's Office of Science Policy's FAQs on NIH Policy on the Use of a Single IRB for MultiSite Research Costs
NIH's Office of Science Policy's FAQs on Implementation of the sIRB policy
NIH Guide Notice on the Revised NIH Policy on sIRB

3.3 Data and Safety Monitoring Plan
A “Data and Safety Monitoring Plan” attachment is required if you answered “Yes” to all the
questions in the “Clinical Trial Questionnaire.” The “Data and Safety Monitoring Plan” attachment
is optional for all other human subjects research.
For human subjects research that does not involve a clinical trial: Your study, although it is
not a clinical trial, may have significant risks to participants, and it may be appropriate to include
a data and safety monitoring plan. If you choose to include a data and safety monitoring plan,
you may follow the content criteria listed below, as appropriate.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:

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Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Include only the following information in your data and safety
monitoring plan (i.e., do not follow the standard instructions for the data and
safety monitoring plan):




The names of the individual(s) or group that will be responsible for trial
monitoring (i.e., the lead investigator of the clinical trial)
If applicable, the name of an independent safety monitor or a data and
safety monitoring board

Additional Instructions for Fellowship:
Fellowship applicants who are proposing to gain clinical trial research
experience under a sponsor’s supervision (i.e., you will not be leading an
independent clinical trial): Include only the following information in your data and
safety monitoring plan (i.e., do not follow the standard instructions for the data and
safety monitoring plan):




The names of the individual(s) or group that will be responsible for trial
monitoring (i.e., the lead investigator of clinical trial)
If applicable, the name of an independent safety monitor or a data and
safety monitoring board

For any proposed clinical trial, NIH requires a data and safety monitoring plan (DSMP) that is
commensurate with the risks of the trial, its size, and its complexity. Provide a description of the
DSMP, including:

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








Indicate how many people and what type of entity will provide the monitoring. Include
such details as whether a single person, multiple people, or a data safety monitoring
board will provide monitoring. Also indicate what type of entity will provide the
monitoring (e.g., PD/PI, Independent Safety Monitor/Designated Medical Monitor,
Independent Monitoring Committee, Safety Monitoring Committee, Data and Safety
Monitoring Board, etc.).
The overall framework for safety monitoring and what information will be monitored.
The frequency of monitoring, including any plans for interim analysis and stopping rules
(if applicable).
The process by which Adverse Events (AEs), including Serious Adverse Events (SAEs) such
as deaths, hospitalizations, and life threatening events and Unanticipated Problems
(UPs), will be managed and reported, as required, to the IRB, the person or group
responsible for monitoring, the awarding IC, the NIH Office of Biotechnology Activities,
and the Food and Drug Administration.
The individual(s) or group that will be responsible for trial monitoring and advising the
appointing entity. Because the DSMP will depend on potential risks, complexity, and the
nature of the trial, a number of options for monitoring are possible. These include, but
are not limited to, monitoring by a:
o

o

o

o

PD/PI: While the PD/PI must ensure that the trial is conducted according to the
approved protocol, in some cases (e.g., low risk trials, not blinded), it may be
acceptable for the PD/PI to also be responsible for carrying out the DSMP.
Independent safety monitor/designated medical monitor: a physician or other expert
who is independent of the study.
Independent Monitoring Committee or Safety Monitoring Committee: a small group
of independent experts.
Data and Safety Monitoring Board (DSMB): a formal independent board of experts
including investigators and biostatisticians. NIH requires the establishment of DSMBs
for multi-site clinical trials involving interventions that entail potential risk to the
participants, and generally, for all Phase III clinical trials, although Phase I and Phase II
clinical trials may also need DSMBs. If a DSMB is used, please describe the general
composition of the Board without naming specific individuals.

For more information:



NIH Grants Policy Statement, Section 4.1.15.6: Data and Safety Monitoring
NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials

3.4 Will a Data and Safety Monitoring Board be appointed for this study?
The “Data Safety and Monitoring Board” question is required if you answered “Yes” to all the
questions in the “Clinical Trial Questionnaire.” This question is optional for all other human
subjects research.
Check the appropriate box to indicate whether a Data Safety and Monitoring Board (DSMB) will
be appointed for this study.

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3.5 Overall Structure of the Study Team
The “Overall Structure of the Study Team” attachment is optional. Refer to your specific FOA for
specific instructions on the "Overall Structure of the Study Team" attachment.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Content:
Provide a brief overview of the organizational/administrative structure and function of the study
team, particularly the administrative sites, data coordinating sites, enrollment/participating sites,
and any separate laboratory or testing centers. The attachment may include information on
study team composition and key roles (e.g., medical monitor, data coordinating center), the
governance of the study, and a description of how study decisions and progress are
communicated and reported.
Note: Do not include study team members’ individual professional experiences (i.e., biosketch
information).

Section 4 – Protocol Synopsis
Who must complete “Section 4 – Protocol Synopsis:"
If you answered "Yes" to all the questions in the "Clinical Trial Questionnaire:" All the questions
in the “Protocol Synopsis” section are required.
If you answered “No” to any question in the “Clinical Trial Questionnaire:” Do not provide
information in this section. Inputting information in this section will result in errors and will prevent
your application from being accepted.
Additional Instructions for Research:
R25 applicants who are proposing to provide clinical trial research experience
for their participants (i.e., participants will not be leading an independent
clinical trial): Do not provide information in “Section 4 - Protocol Synopsis.”
Inputting information in this section will result in errors and will prevent your
application from being accepted.
R36 applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not provide information in “Section 4 - Protocol Synopsis.”
Inputting information in this section will result in errors and will prevent your
application from being accepted.
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not provide information in “Section 4 - Protocol Synopsis.”

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Inputting information in this section will result in errors and will prevent your
application from being accepted.
Additional Instructions for Training:
K12 and D43 applicants who are proposing to provide clinical trial research
experience for their Scholars/Trainees (i.e., Scholars/Trainees will not be
leading an independent clinical trial): At the time of your application, do not
provide information in “Section 4 – Protocol Synopsis.” Inputting information in this
section will result in errors and will prevent your application from being accepted.
Post-award, while you will be required to fill out Study Records, you must still not
provide information in “Section 4 – Protocol Synopsis.”
Additional Instructions for Fellowship:
Fellowship applicants proposing to gain clinical trial research experience under
a sponsor’s supervision (i.e., you will not be leading an independent clinical
trial): Do not provide information in “Section 4 - Protocol Synopsis.” Inputting
information in this section will result in errors and will prevent your application
from being accepted.

4.1. Study Design
4.1.a. Detailed Description

Enter a narrative description of the protocol. Studies differ considerably in the methods used to
assign participants and deliver interventions. Describe your plans for assignment of participants
and delivery of interventions. You will also need to show that your methods for sample size and
data analysis are appropriate given those plans. For trials that randomize groups or deliver
interventions to groups, special methods are required; additional information is available at the
Research Methods Resources webpage. The Narrative Study Description is not meant to be a
repeat of the Research Strategy.
The narrative description is limited to 32,000 characters (but typically needs only 5,000
characters), should be written in layperson’s terms, and may repeat some of the information in
the Research Strategy.
Note: This field matches a ClinicalTrials.gov field (Detailed Description).

For more information about formatting text entry fields, see NIH's Rules for Text Fields page.
4.1.b. Primary Purpose

Enter or select from the dropdown menu a single "Primary Purpose" that best describes the
clinical trial. Choose from the following options:







Treatment
Prevention
Diagnostics
Supportive Care
Screening
Health Services Research

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



Basic Science
Device Feasibility
Other (If you select “Other,” provide a description in the space provided. Your response
is limited to 255 characters.)

Note: This field matches a ClinicalTrials.gov field (Primary Purpose).
4.1.c. Interventions

Complete the “Interventions” fields for each intervention to be used in your proposed protocol. If
an arm of the study to which subjects will be assigned (as discussed in 4.1.a. Detailed Description)
includes more than one intervention (e.g., drug plus educational intervention), complete this
section for each intervention. You can add up to 20 interventions.
Intervention Type: Enter or select from the dropdown menu the intervention type the clinical
trial will administer during the proposed award. Choose from the following options:












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)
Dietary Supplement (e.g., vitamins, minerals)
Combination Product
Diagnostic Test
Other

Name: Enter the name of the intervention. The name is limited to 200 characters.

Description: Enter a description of the intervention. The description is limited to 1,000
characters.
Note: This field matches a ClinicalTrials.gov field. (Interventions, including Intervention Type and
Intervention Name(s)).
For more information on how to answer this question for behavioral research trials, refer to the
relevant FAQ on the Applying Electronically FAQ page.
4.1.d. Study Phase

Enter or select from the dropdown menu a "Study Phase" that best describes the clinical trial. If
your study involves a device or behavioral intervention, choose “Other.”
Choose from the following options:





Early Phase 1 (or Phase 0)
Phase 1
Phase 1/2
Phase 2

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




Phase 2/3
Phase 3
Phase 4
N/A

Is this an NIH-defined Phase III clinical trial? Yes/No
Select "Yes" or "No" to indicate whether the study includes an NIH-defined Phase III clinical trial.
Device and behavioral intervention studies may select “Yes” here even if the answer above is
“Other”.
For more information on how to answer this question for devices or behavioral interventions,
refer to the relevant FAQ on the Applying Electronically FAQ page.
4.1.e. Intervention Model

Enter or select from the dropdown menu a single "Intervention Model" that best describes the
clinical trial. If you select “Other,” provide a description in the space provided. Choose from the
following options:







Single Group
Parallel
Cross-Over
Factorial
Sequential
Other (If you select “Other,” provide a description in the space provided. Your response
is limited to 255 characters.)

Note: This field matches a ClinicalTrials.gov field (Interventional Study Model).

For more information: Definitions of intervention models may be found in ClinicalTrials.gov’s
Glossary of Common Site Terms or in the ClinicalTrials.gov’s description of Study Design.
4.1.f. Masking

Select "Yes" or "No" to indicate whether the protocol uses masking. Note that masking is also
referred to as “blinding.”
If you answered “Yes” to the “Masking” question, select one or more types of masking that best
describes the protocol. Choose from the following options:





Participant
Care Provider
Investigator
Outcomes Assessor

Note: This field matches a ClinicalTrials.gov field (Masking).
4.1.g. Allocation

Enter or select from the dropdown menu a single "Allocation" that best describes how subjects
will be assigned in your protocol. If allocation is not applicable to your clinical trial, select “N/A”
(e.g., for a single-arm trial). Choose from the following options:

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



N/A
Randomized
Non-randomized

Note: This field matches a ClinicalTrials.gov field (Allocation).

4.2. Outcome Measures
Complete the “Outcome Measures” fields for each primary, secondary, and other important
measures to be collected during your proposed clinical trial. You may have more than one
primary outcome measure, and you can add up to 50 outcome measures.
Name: Enter the name of the individual outcome measure. The outcome measure must be
unique within each Study Record.
Type: Enter or select from the dropdown menu the type of the outcome measure. Choose from
the following options:






Primary – select this option for the outcome measures specified in your protocol that are
of greatest importance to your study
Secondary – select this option for outcome measures specified in your protocol that are
of lesser importance to your study than your primary outcomes
Other – select this option for additional key outcome measures used to evaluate the
intervention.

Time Frame: Indicate when a measure will be collected for analysis (e.g., baseline, posttreatment).
Brief Description: Describe the metric used to characterize the outcome measure if the metric is
not already included in the outcome measure name. Your description is limited to 999 characters.
NIH-Defined Phase III Clinical Trials: If the proposed research includes an NIH-Defined Phase
III Clinical Trial, then outcomes for required analyses by sex/gender, race, and ethnicity should be
entered.
Additional information about valid analysis is available on the NIH Policy and Guidelines on The
Inclusion of Women and Minorities as Subjects in Clinical Research page.
Note: This field matches a ClinicalTrials.gov field (e.g., Primary Outcome Measure Information,
which includes Title, Description, and Time Frame).
For more information:


Refer to the relevant FAQ for question 4.2 Outcome Measures on the Applying
Electronically FAQ page.

4.3. Statistical Design and Power
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.

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Content:
Specify the number of subjects you expect to enroll, the expected effect size, the power, and the
statistical methods you will use with respect to each outcome measure you listed in 4.2 Outcome
Measures.
You will need to show that your methods for sample size and data analysis are appropriate given
your plans for assignment of participants and delivery of interventions. For trials that randomize
groups or deliver interventions to groups, special methods are required; additional information is
available at the Research Methods Resources webpage.

4.4 Subject Participation Duration
Enter the time (e.g., in months) it will take for each individual participant to complete all study
visits. If the participation duration is unknown or not applicable, write “unknown” or “not
applicable.” The subject participation duration is limited to 255 characters.

4.5 Will the study use an FDA-regulated intervention?
Select "Yes" or "No" to indicate whether the study will use an FDA-regulated intervention (see the
definition of “FDA Regulated Intervention” under the Oversight section of the ClinicalTrials.gov
Protocol Registration Data Element Definitions for Interventional and Observational Studies
page).
4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New
Drug (IND)/Investigational Device Exemption (IDE) status:

This attachment is required if you answered “Yes” to the “Will the study use an FDA-regulated
intervention?” question.
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
This attachment’s typical length is approximately 3,000 characters.
Content:
Provide a summary describing the availability of study agents and support for the acquisition and
administration of the study agent(s).
Please indicate, if applicable, the IND/IDE status of the study agent, including whether a clinical
investigation is exempt from the IND/IDE requirement. Also indicate whether the investigators
have had any interactions with the FDA (e.g., indicate if the FDA has stated that research may
proceed). If the study agent currently has an IND/IDE number, provide that information.
Do not include the IND/IDE application, manufacturer’s product specifications, study protocol, or
protocol amendments in this attachment.
Additional information such as FDA letters or correspondence with the FDA may be requested in
the FOA.
Note: The awarding component may request consultation with the FDA and the IND/IDE
sponsor about the proposed clinical trial after peer review and prior to award.

4.6 Is this an applicable clinical trial under FDAAA?
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Select "Yes" or "No" to indicate whether the study is an applicable clinical trial (ACT) under the
Food and Drug Administration Amendments Act (FDAAA).
For more information:



NIH Glossary’s definition of an applicable clinical trial
FAQs on the ClinicalTrials.gov & FDAAA

4.7 Dissemination Plan
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.
Although one Dissemination Plan per application is sufficient, you must include a file for each
study within your application. All filenames within your application must be unique. You may
either attach the same Dissemination Plan to different studies or attach a file that refers to the
Dissemination Plan in another study within your application. For example, you may attach a file
that says “See Dissemination Plan in the 'My Unique Study Name' study.”
Content:
Explain briefly your plan for the dissemination of NIH-funded clinical trial information and
address how the expectations of the policy will be met. The plan must contain sufficient
information to assure the following:






the applicant will ensure that clinical trial(s) under the award are registered and results
information is submitted to ClinicalTrials.gov as outlined in the policy and according to
the specific timelines stated in the policy;
informed consent documents for the clinical trial(s) will include a specific statement
relating to posting of clinical trial information at ClinicalTrials.gov; and
the recipient institution has an internal policy in place to ensure that clinical trials
registration and results reporting occur in compliance with policy requirements.

Note: Do not include informed consent documents in the Dissemination Plan attachment.

Note: If your human subjects study meets the definition of “Delayed Onset,” include the
Dissemination Plan attachment in the delayed onset study justification.
For more information:





See the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
See the NIH Guide Notice on the Delayed Enforcement and Short-Term Flexibilities for
Some Requirements Affecting Prospective Basic Science Studies Involving Human
Participants
See the NIH Grants Policy Statement, Section 4.1.3.1 NIH Policy on Dissemination of NIHFunded Clinical Trial Information.

Section 5 – Other Clinical Trial-related Attachments
Who must complete “Section 5 – Other Clinical Trial-related Attachments:"
If you answered “Yes” to all the questions in the “Clinical Trial Questionnaire:” Include an
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attachment only if your FOA specifies that an attachment(s) is required or permitted; otherwise, do
not include any Other Clinical Trial-related attachments.

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If you answered “No” to any question in the “Clinical Trial Questionnaire:” Do not provide
information in this section. Inputting information in this section will result in errors and will prevent
your application from being accepted.
Additional Instructions for Research:
R25 applicants who are proposing to provide clinical trial research experience
for their participants (i.e., participants will not be leading an independent
clinical trial): Do not provide information in “Section 5 – Other Clinical Trial-related
Attachments.” Inputting information in this section will result in errors and will
prevent your application from being accepted.
R36 applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not provide information in “Section 5 – Other Clinical Trial-related
Attachments.” Inputting information in this section will result in errors and will
prevent your application from being accepted.
Additional Instructions for Career Development:
CDA applicants who are proposing to gain clinical trial research experience
under a mentor’s supervision (i.e., you will not be leading an independent
clinical trial): Do not provide information in “Section 5 – Other Clinical Trial-related
Attachments.” Inputting information in this section will result in errors and will
prevent your application from being accepted.
Additional Instructions for Training:
K12 and D43 applicants who are proposing to provide clinical trial research
experience for their Scholars/Trainees (i.e., Scholars/Trainees will not be
leading an independent clinical trial): At the time of your application, do not
provide information in “Section 5 – Other Clinical Trial-related Attachments.”
Inputting information in this section will result in errors and will prevent your
application from being accepted. Post-award, while you will be required to fill out
Study Records, you must still not provide information in “Section 5 – Other Clinical
Trial-related Attachments.”
Additional Instructions for Fellowship:
Fellowship applicants proposing to gain clinical trial research experience under
a sponsor’s supervision (i.e., you will not be leading an independent clinical
trial): Do not provide information in “Section 5 – Other Clinical Trial-related
Attachments.” Inputting information in this section will result in errors and will
prevent your application from being accepted.

5.1 Other Clinical Trial-related Attachments
Format:
Attach this information as a PDF file. See NIH’s Format Attachments page.

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A maximum of 10 PDF attachments is allowed in the “Other Clinical
Trial-related Attachments” section.
Content:
Provide additional trial-related information only if your FOA
specifically requests it. Include only attachments requested in the
FOA, and use requested filenames. If a specific filename is not given in
the FOA, use a meaningful filename since it will become a bookmark
in the assembled application image.

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