The PHS Human Subjects and Clinical Trials Information form is essential for gathering detailed information about human subjects research, clinical research, and clinical trials. This includes crucial aspects such as study population characteristics, protection and monitoring strategies, and a concise protocol overview.
This form is versatile, designed to accommodate the full spectrum of clinical trial types. Whether your research involves behavioral studies, exploratory or developmental phases, mechanistic investigations, pilot or feasibility studies, early phase trials, efficacy or effectiveness research, group-randomized trials, or other methodologies, this form is applicable.
Before you begin, it is crucial to thoroughly review all instructions within the Funding Opportunity Announcement (FOA). This ensures your application aligns with all specific criteria set by the relevant IC. Section II of the FOA, “Award Information,” will specify if clinical trials are permitted or not, and whether clinical trial research experience is allowed. The FOA designation is your guide to using these instructions and accurately completing the form.
The PHS Human Subjects and Clinical Trials Information form, in conjunction with your complete application, should provide a self-contained, comprehensive project evaluation resource, eliminating dependence on external documents like previous applications. Precision and clarity are key—describe each study distinctly and avoid unnecessary repetition, especially with your research strategy.
Quick Navigation
PHS Human Subjects and Clinical Trials Information | Guidance for No Human Subjects Involvement | Guidance for Human Subjects Involvement | Other Requested Information | Study Record Guidance | Delayed Onset Study Guidance | Study Record: PHS Human Subjects and Clinical Trials Information | Section 1 – Basic Information | Section 2 – Study Population Characteristics | Inclusion Enrollment Report Guidance | Section 3 – Protection and Monitoring Plans | Section 4 – Protocol Synopsis | Section 5 – Other Clinical Trial-Related Attachments
Complete the PHS Human Subjects and Clinical Trials Information form after finalizing the G.220 – R&R Other Project Information Form.
This form is designed to be adaptable, accommodating a wide range of clinical trial types, such as exploratory/developmental, mechanistic, pilot/feasibility, early phase, efficacy, effectiveness, and group-randomized trials, among others.
Who Needs to Use This Form?
Regardless of your response to “Are human subjects involved?” on the G.220 – R&R Other Project Information Form, all applicants are required to use the PHS Human Subjects and Clinical Trials Information form.
- If you answered “Yes” to “Are human subjects involved?” on the G.220 – R&R Other Project Information Form, refer to the “If Yes to Human Subjects” section for detailed instructions.
- If you answered “No” to “Are human subjects involved?” on the G.220 – R&R Other Project Information Form, see the “If No to Human Subjects” section for the appropriate guidance.
Specific Instructions for Training Grants:
K12 and D43 Applicants: If your application includes any human subject studies, you must utilize the PHS Human Subjects and Clinical Trials Information form to submit delayed onset studies at the time of application. Study Records should not be completed at this stage. Adhere to the instructions in your FOA. Post-award, you will submit Study Records if necessary.
All Other Training Grant Applicants: This form is not applicable and will not be accessible to you.
Important Note for Secondary Data/Biospecimen Use: For studies exclusively involving secondary use of identifiable biospecimens or data originally collected for a different primary purpose, complete the PHS Human Subjects and Clinical Trials Information form with details specific to the current study. Avoid referencing the original collection unless it’s directly relevant to your proposed research. If original collection details are necessary, provide clear context and differentiate between the current study and historical data.
How to Effectively Use the PHS Human Subjects and Clinical Trials Information Form:
Follow the form-specific instructions based on your answer to the “Are Human Subjects Involved?” question on the G.220 – R&R Other Project Information Form. The form allows for the addition of Study Record(s) and/or Delayed Onset Study(ies) as needed.
Within each Study Record: PHS Human Subjects and Clinical Trials Information, you will input detailed information at the study level. Avoid study duplication within your application. Each study must be unique and have a distinct title. Each Study Record is structured into numbered sections:
- Section 1 – Basic Information
- Section 2 – Study Population Characteristics (Including Inclusion Enrollment Report)
- Section 3 – Protection and Monitoring Plans
- Section 4 – Protocol Synopsis
- Section 5 – Other Clinical Trial-related Attachments
Key Point: While referencing information from the PHS Human Subjects and Clinical Trials Information form in your Research Strategy discussion is encouraged, avoid duplicating content between the Research Strategy attachment and the form itself.
For a clearer understanding of what constitutes a “study” within the context of the PHS Human Subjects and Clinical Trials Information form, consult the relevant FAQ on the Applying Electronically FAQ page.
The PHS Human Subjects and Clinical Trials Information form is designed to be dynamic, potentially hiding sections irrelevant to your application. However, dynamic behavior might not be supported across all submission platforms.
Important Note: Some fields in this form are mirrored in ClinicalTrials.gov and are identified as such in these instructions. Further details on these fields can be found on the ClinicalTrials.gov Protocol Registration Data Element Definitions website.
Additional Instructions for Research Grants:
R25 Applicants (Clinical Trial Research Experience): If you are proposing to offer clinical trial research experience to participants (where participants will not lead independent clinical trials), generally follow standard instructions for the PHS Human Subjects and Clinical Trials Information form. However, adhere to specific Research instructions where provided. Ensure your FOA permits Clinical Trial Research Experience (check “Section II. Award Information” of the FOA). Your mentor or co-mentor must provide a statement documenting their clinical trial leadership, including:
- Funding source
- ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable
- Description of mentor’s expertise relevant to guiding participants in proposed clinical trials research experience
- Attestation that the mentor will be responsible for the clinical trial
The mentor must have primary responsibility for leading and overseeing the trial, detailing their oversight approach and specific roles/responsibilities of both mentor and participants. Include this statement in the “Other Attachments” section of the G.220 – R&R Other Project Information Form.
R36 Applicants (Clinical Trial Research Experience): For R36 applicants gaining clinical trial research experience under mentorship (not leading independent trials), follow standard instructions for the PHS Human Subjects and Clinical Trials Information form, but refer to Research instructions where applicable. Confirm your FOA allows Clinical Trial Research Experience (see “Section II. Award Information” of the FOA). A mentor or co-mentor statement is required to document clinical trial leadership, including:
- Funding source
- ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable
- Description of mentor’s expertise in guiding the applicant in proposed clinical trials research experience
- Attestation that the mentor will assume responsibility for the clinical trial
The mentor must have primary responsibility for trial leadership and oversight, describing their oversight role, and detailing specific roles/responsibilities of both applicant and mentor (avoid overstating the candidate’s responsibilities). Include this statement in the “Letters of Support” section of the G.400 – PHS 398 Research Plan Form.
All Other Research Grant Applicants: Follow the standard instructions for completing the PHS Human Subjects and Clinical Trials Information form.
Additional Instructions for Career Development Awards:
K applicants have three main scenarios for applying for human subjects and/or clinical trial research.
Career Development Award (CDA) Applicants (No Clinical Trial): Follow the standard instructions for the PHS Human Subjects and Clinical Trials Information form.
CDA Applicants (Independent Clinical Trial): If proposing an independent clinical trial, ensure your FOA permits independent clinical trials (see “Section II. Award Information” of the FOA). Follow standard instructions for the form. Note that not all Study Records must be clinical trials. For more information on independent clinical trials, refer to NIH guidelines.
CDA Applicants (Clinical Trial Research Experience): For CDA applicants gaining clinical trial research experience under mentorship (not leading independent trials), generally follow standard instructions, but refer to Career Development instructions where provided. Verify your FOA allows Clinical Trial Research Experience (see “Section II. Award Information” of the FOA). A mentor or co-mentor statement is required to document clinical trial leadership, including:
- Funding source
- ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable
- Description of mentor’s expertise in guiding the applicant in proposed clinical trials research experience
- Attestation that the mentor will be responsible for the clinical trial
The mentor must have primary responsibility for trial leadership and oversight, describing their oversight approach and detailing specific roles/responsibilities of both applicant and mentor, considering CDA award terms may limit candidate-led clinical trials. Include this statement in the “Plans and Statements of Mentor and Co-Mentor(s)” section of the G.410 – PHS 398 Career Development Award Supplemental Form..
Additional Instructions for Fellowships:
Fellowship applicants can conduct human subjects research but are not permitted to lead an independent clinical trial.
For detailed information, see NIH FAQs regarding:
- F awards and clinical trials
- Why Fellows cannot lead independent clinical trials
- Fellow responsibilities in clinical trial research experience
- Responsibility for clinical trials in Fellowship applications
Fellowship Applicants (No Clinical Trial): Follow standard instructions for the PHS Human Subjects and Clinical Trials Information form.
Fellowship Applicants (Clinical Trial Research Experience): For fellowship applicants gaining clinical trial research experience under a sponsor’s supervision (not leading independent trials), generally follow standard instructions, but refer to Fellowship instructions where provided. Ensure your FOA allows Clinical Trial Research Experience (see “Section II. Award Information” of the FOA). A sponsor or co-sponsor statement is needed to document clinical trial leadership, including:
- Funding source
- ClinicalTrials.gov identifier (e.g., NCT87654321), if applicable
- Description of sponsor’s expertise in guiding the applicant in proposed clinical trials research experience
- Attestation that the sponsor will be responsible for the clinical trial
The sponsor must have primary responsibility for trial leadership and oversight, detailing their oversight approach and specific roles/responsibilities of both fellow and sponsor, noting that fellowship terms do not allow fellow-led clinical trials. Include this statement in the “Sponsor and Co-Sponsor Statements” section of the G.430 – PHS Fellowship Supplemental Form.
Additional Instructions for Multi-project Applications:
Self-Contained Studies within a Single Component:
- Overall Component: Do not complete a Study Record.
- Other Component: Complete a separate Study Record for each self-contained human subjects study within each component.
Studies Spanning Multiple Components:
- Overall Component: Complete one Study Record per study spanning multiple components. This record should include sufficient detail for all involved components. This scenario may occur with data coordinating centers, recruitment cores, or when participant assessments are across components (e.g., imaging core and clinical site).
Important Note: All applicants must adhere to formatting policies, proprietary information guidelines, human subjects regulations, and clinical trial requirements. There are no page limits for attachments in the PHS Human Subjects and Clinical Trials Information form.
PHS Human Subjects and Clinical Trials Information Form – Detailed Sections
Applicants must complete the human subjects questions in the G.220 – R&R Other Project Information Form before proceeding with this form.
Are Human Subjects Involved? (Yes/No)
This field is automatically populated from the G.220 – R&R Other Project Information Form. Correct any discrepancies by adjusting your answer in the G.220 – R&R Other Project Information Form.
Is the Project Exempt from Federal Regulations? (Yes/No)
Pre-populated from the G.220 – R&R Other Project Information Form. Correct inaccuracies in the G.220 – R&R Other Project Information Form.
Exemption Number: (1, 2, 3, 4, 5, 6, 7, 8)
Also pre-populated from the G.220 – R&R Other Project Information Form. Adjust in the G.220 – R&R Other Project Information Form if needed.
Caution: Changing your answer to “Are Human Subjects Involved” in the G.220 – R&R Other Project Information Form after starting data entry in the PHS Human Subjects and Clinical Trials Information form may result in data loss.
Guidance for Applications Answering “No” to Human Subjects Involvement
If you answered “No” to “Are Human Subjects Involved?” on the G.220 – R&R Other Project Information Form, address the following questions regarding the use of human specimens and/or data.
Does the proposed research involve human specimens and/or data? (Yes/No)
Select “Yes” or “No” to indicate if your research uses human specimens and/or data.
Research involving human specimens or data may or may not be classified as human subjects research, depending on the specifics of the materials used. Consult the Research Involving Private Information or Biological Specimens flowchart to determine the classification of your research.
Note: If you answer “No” to “Does the proposed research involve human specimens and/or data?”, skip the remainder of the PHS Human Subjects and Clinical Trials Information form unless your FOA directs otherwise.
If Yes, explain why the application does not involve human subjects research.
If you answered “Yes” to the use of human specimens/data, justify why it is not considered human subjects research.
Attach your justification as a PDF file, following NIH’s Format Attachments guidelines.
Your justification should include:
- Information on data/biospecimen providers and their role in the research.
- Description of identifiers associated with human specimens and data.
- List of individuals with access to subjects’ identities.
- Measures to protect participant privacy and data confidentiality.
Note: After attaching the justification, skip the rest of the PHS Human Subjects and Clinical Trials Information form unless instructed differently by your FOA.
Guidance for Applications Answering “Yes” to Human Subjects Involvement
If you answered “Yes” to “Are Human Subjects Involved?” on the G.220 – R&R Other Project Information Form, add a Study Record for each proposed human subjects study by selecting “Add New Study” or “Add New Delayed Onset Study” as appropriate.
Other Requested Information
Who Can Provide “Other Requested Information”:
Follow the guidelines here and in your FOA to determine if you should include the “Other Requested Information” attachment.
Format:
Attach information as a PDF file, adhering to NIH’s Format Attachments guidelines.
Content:
Content must be limited to what is specified in your FOA or these instructions. Do not include any extraneous information in the “Other Requested Information” attachment.
Renewal Applications: For renewals (or resubmissions), provide a list of ongoing studies or ClinicalTrials.gov identifiers (e.g., NCT87654321).
Additional Instructions for Multi-project Applications:
Studies Spanning Components:
- Overall Component: For each study spanning components, describe the components involved.
- Other Components: Each component should include an attachment stating that study details are in the Overall component attachment.
For further guidance, 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) Guidance
Adding Study Record Attachments:
Add a study record for each proposed human subjects study. For studies with specific plans that can be described but will not start immediately (delayed start), you must add a Study Record. For studies anticipating human subjects involvement within the award period but lacking specific plans at application (delayed onset), see Delayed Onset Study(ies) instructions.
The Study Record collects human subjects study data across all submission methods. Note: Steps to add Study Records may vary by submission method. For example, in ASSIST, use ‘Add New Study’ in the Human Subjects and Clinical Trials tab to directly enter data. Other methods may require extracting a blank Study Record, completing it offline, and attaching it.
Grouping Studies into Study Records: Group studies using the same human subjects population and protocols into a single Study Record for clarity and accuracy for NIH reviewers.
For identical information across studies, include it fully only in the first relevant Study Record. In subsequent records, upload an attachment stating, “See information for attachment X in Study Record entitled [study title].” Avoid duplicated attachments across Study Records. Do not number Study Records by number. Examples of attachments that may be identical include 3.1 Protection of Human Subjects and 3.5 Overall Structure of the Study Team.
Refer to NIH Glossary definitions for Study and Study Record.
The form supports up to 150 Study Records.
Format:
All attachments must be PDF files. Extracted Study Records are already in fillable PDF format—use this format without alteration. Use unique filenames for each human subject study record and ensure each attachment filename within a study is unique across the application.
Content:
Follow the instructions in the “Study Record: PHS Human Subjects and Clinical Trials Information” section below.
Delayed Onset Study(ies) Guidance
Additional Instructions for Training Grants:
K12 and D43 Applicants: For applications including human subject studies, use the PHS Human Subjects and Clinical Trials Information form to submit delayed onset studies at application time. Follow FOA instructions. Submit Study Records post-award if applicable.
If you expect to conduct human subjects research but cannot fully describe it at application (delayed onset human subject study), enter a Delayed Onset Study Record as instructed below.
Generally, for delayed onset studies, include a study title, indicate if it’s anticipated to be a clinical trial, and add a justification attachment. Since delayed onset study details are unavailable at application, completing a full Study Record is not required. The Delayed Onset Study Record is sufficient.
Notes on Delayed Onset Studies:
- Delayed onset is not for studies that are describable but start later (delayed start). See NIH Glossary for definitions of Delayed Onset Study and Delayed Start.
- Multiple delayed onset studies can be combined into a single Delayed Onset Study Record.
Study Title (Required)
Maximum 600 characters.
Enter a brief, unique title describing the study participants will be involved in. Each study in your application must have a unique title. The first 150 characters appear in application image bookmarks.
Note on Multiple Delayed Onset Studies: Use “Multiple Delayed Onset Studies” as the title if combining multiple studies in one record.
Anticipated Clinical Trial? (Required)
Check if you anticipate the study to be a clinical trial. See the Clinical Trial Questionnaire for definition.
Carefully review your FOA to confirm if clinical trials are permitted.
Note on Multiple Delayed Onset Studies: If including multiple delayed onset studies and any are expected to be clinical trials, check the “Anticipated Clinical Trial?” box.
Additional Instructions for Career Development Awards:
CDA Applicants (No Clinical Trial): Follow standard instructions.
CDA Applicants (Independent Clinical Trial): Follow standard instructions.
CDA Applicants (Clinical Trial Research Experience): Do not check “Anticipated Clinical Trial?” box.
Additional Instructions for Fellowships:
Do not check “Anticipated Clinical Trial?” box. Fellowship FOAs do not allow independent clinical trials.
Justification Attachment (Required)
Attach justification as a PDF file, following NIH’s Format Attachments guidelines.
- Justify why human subjects study information is unavailable at application time for all delayed onset studies.
- If NIH’s Single Institutional Review Board (sIRB) policy applies, include compliance information and state that you will provide a single IRB plan before initiating any multi-site study.
- If NIH’s Policy on Dissemination of NIH-Funded Clinical Trial Information applies, include the dissemination plan.
Note on Multiple Delayed Onset Studies: Address all included studies in a single justification attachment.
Study Record: PHS Human Subjects and Clinical Trials Information – Section by Section Guide
Section 1 – Basic Information
Who Must Complete Section 1:
Required for all human subjects studies.
1.1 Study Title (Unique Title Required)
The “Study Title” field is mandatory.
Maximum 600 characters.
Enter a concise title describing the study participants will engage in. Each study (Study Record and/or delayed onset study) must have a unique title. The first 150 characters will be displayed in the application image bookmarks.
Note: For ClinicalTrials.gov registration, all study titles within your organization must be unique.
Note: This field corresponds to the ClinicalTrials.gov field (Official Title).
1.2 Is this Study Exempt from Federal Regulations? (Yes/No)
A response is required.
Indicate if the study is exempt from federal regulations for human subject protection.
For more information, see the NIH’s Exempt Human Subjects Research infographic.
1.3 Exemption Number
Required if “Yes” is selected for “Is this Study Exempt?”.
Select applicable exemption number(s) for this study. Multiple selections are allowed. Application instructions must be followed regardless of potential future exemptions.
Further Information:
Exemption categories are defined in the Common Rule for Human Subject Protection, 45 CFR 46.
Need help determining the appropriate exemption number?
OHRP guidance suggests that exemption appropriateness should be determined by an authority independent of investigators (see OHRP’s FAQs). Institutions often task IRBs with this. As NIH doesn’t require IRB approval at application, PD/PI opinions on exemptions and their justifications are peer-reviewed.
1.4 Clinical Trial Questionnaire
This questionnaire is mandatory.
Note for Basic and Mechanistic Studies: NIH’s clinical trial definition is broad, including studies with human participants aimed at understanding fundamental phenomena, disease pathophysiology, or intervention mechanisms. This includes many mechanistic studies and studies submitted to Basic Experimental Studies with Humans FOAs.
Answer “Yes” or “No” to determine if your study is a clinical trial. Answer based solely on the study described in this Study Record.
1.4.a. Does the study involve human participants? (Yes/No)
1.4.b. Are participants prospectively assigned to an intervention? (Yes/No)
1.4.c. Is the study designed to evaluate the intervention’s effect on participants? (Yes/No)
1.4.d. Is the evaluated effect a health-related biomedical or behavioral outcome? (Yes/No)
If you answered “Yes” to all questions, your study meets the clinical trial definition.
Refer to the table below for required form sections based on your Clinical Trial Questionnaire answers.
| Form Section | If “yes” to all Clinical Trial Questionnaire questions | If “no” to any Clinical Trial Questionnaire questions |
|---|---|---|
| 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 Trial-related Attachments | Required if specified in FOA | Do not complete |
Additional Instructions for Research Grants:
R25 & R36 Applicants (Clinical Trial Research Experience): Even with “Yes” to all Clinical Trial Questionnaire questions, only specific PHS Human Subjects and Clinical Trials Information form fields are required (others not allowed) because the study is not an independent clinical trial. Do not complete “Section 4 – Protocol Synopsis” or “Section 5 – Other Clinical Trial-related Attachments.” Inputting data in these sections will cause errors and application rejection.
Additional Instructions for Career Development Awards:
CDA Applicants (Clinical Trial Research Experience): Similar to Research grant applicants gaining experience, do not complete “Section 4 – Protocol Synopsis” or “Section 5 – Other Clinical Trial-related Attachments,” even if answering “Yes” to all Clinical Trial Questionnaire questions, as the study is not an independent clinical trial.
Additional Instructions for Fellowships:
Fellowship Applicants (Clinical Trial Research Experience): Like CDA and specific Research grants, do not complete “Section 4 – Protocol Synopsis” or “Section 5 – Other Clinical Trial-related Attachments,” even with “Yes” responses to the Clinical Trial Questionnaire, as the study isn’t an independent clinical trial.
Further Information:
Refer to NIH resources for more details on clinical trial definitions and requirements.
1.5. ClinicalTrials.gov Identifier (If Applicable)
If the clinical trial is already registered on ClinicalTrials.gov, enter its identifier (e.g., NCT87654321).
For ancillary studies, provide the ClinicalTrials.gov identifier for the ancillary study only, if registered separately, not for the parent study.
Note: Ensure the entered number matches the ClinicalTrials.gov assigned identifier.
Section 2 – Study Population Characteristics
Who Must Complete Section 2:
Section 2 is fully required (except for Question 2.8 Enrollment of First Subject) for all human subjects studies, unless specified otherwise.
2.1 Conditions or Focus of Study
At least one entry is required, up to 20 entries allowed (one per line), each limited to 255 characters.
Identify disease(s) or condition(s) studied, or the study focus. Use descriptors from NLM’s Medical Subject Headings (MeSH) if possible for application categorization. Include an entry for each condition.
Note: This field matches the ClinicalTrials.gov field (Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study).
2.2 Eligibility Criteria
List study inclusion and exclusion criteria. Use bullet points (e.g., “- “) for lists. Check formatting in the assembled application image. Detailed explanations belong in the Recruitment and Retention plan.
Text entry limit: 15,000 characters (typically 500 characters needed).
Note: This corresponds to the ClinicalTrials.gov field (Eligibility Criteria).
Refer to NIH’s Rules for Text Fields and ClinicalTrials.gov’s User’s Guide for formatting guidance.
2.3 Age Limits
Minimum Age
Enter the minimum age in numerical value and units (years, months, weeks, days, hours, minutes). Use “N/A (No Limit)” if no lower limit or unknown.
Maximum Age
Enter the maximum age in numerical value and units. Use “N/A (No Limit)” if no upper limit or unknown.
Note: This field matches the ClinicalTrials.gov field (Age Limits).
2.4 Inclusion of Women, Minorities, and Children
Format:
Attach information as a PDF file, following NIH’s Format Attachments guidelines.
A new policy on Inclusion of Individuals Across the Lifespan takes effect for applications due on or after January 25, 2019. Use instructions appropriate for your application due date. Note that inclusion instructions are updated for due dates from January 25, 2019 onwards.
Instructions for applications due on or before January 24, 2019:
Content:
Organize your attachment into two sections: “Inclusion of Women and Minorities” and “Inclusion of Children,” addressing the points below under each heading. Include any additional information requested in the FOA.
You will also need to complete an Inclusion Enrollment Report (IER). Multiple IERs per study may be required. See IER instructions.
1. Inclusion of Women and Minorities
Address these points:
- Planned subject distribution by sex/gender, race, and ethnicity.
- Rationale for selecting these groups, based on scientific objectives and study design, including population characteristics of the studied condition.
- Proposed outreach programs for recruiting these groups.
- Justification for limiting inclusion of any group by sex/gender, race, or ethnicity. Cost or geographic location are generally unacceptable reasons. See the Inclusion of Women and Minorities Policy Implementation Page.
Existing Datasets/Resources: If using existing data, resources, or samples, address inclusion as above, detailing sex/gender, race, and ethnicity of the dataset and justifying its appropriateness for study goals.
See NIH FAQs on Monitoring Inclusion with Existing Datasets.
NIH-Defined Phase III Clinical Trials: For Phase III trials, the attachment MUST address plans for considering sex/gender, race, and ethnicity in trial design and valid analysis. See “Valid Analysis” and “Plans to test for Differences” instructions below.
See the NIH Inclusion of Women and Minorities Guidelines for valid analysis details.
Valid Analysis (Phase III Trials only):
Address valid analysis by:
- Using inclusive eligibility criteria (cost/location are generally not acceptable exclusion reasons).
- Randomizing participant allocation to intervention/control groups.
- Ensuring unbiased outcome evaluation.
- Using unbiased statistical analyses to compare intervention effects across sex/gender, race, ethnicity, especially if prior evidence suggests differences.
Plan to Test for Differences in Effect (Phase III Trials only):
Address plans to test for differences in intervention effect among sex/gender, racial, and ethnic groups, and justify whether testing is appropriate, selecting one of these analysis plans:
- Analyze for significant differences if prior studies strongly support subgroup differences.
- Include and analyze subgroups if prior studies show no significant differences (representation is encouraged, but not required for subject selection).
- Conduct valid subgroup analyses (without high power for each subgroup) if prior studies are inconclusive.
2. Inclusion of Children
Children are under 18 years old. Justify excluding any age group (e.g., older adults). Address these points:
- Indicate if children (or subsets under 18) will be included or excluded. Justify age range selection if including, or exclusion if not. See the NIH Inclusion of Children Policy for exclusion justifications.
- Describe investigative team expertise in working with children of included ages, facility appropriateness, and sufficient child numbers for meaningful analysis.
- When children are involved, HHS’ 45 CFR 46, Subpart D applies and must be addressed in the Protection of Human Subjects attachment.
Further Information:
See NIH resources on inclusion policies.
A new policy on Inclusion of Individuals Across the Lifespan takes effect for applications due on or after January 25, 2019. Use instructions appropriate for your application due date. Instructions for applications due on or after January 25, 2019:
Content:
Organize your attachment into “Inclusion of Women and Minorities” and “Inclusion of Children” sections, addressing the points below under each heading. Include any additional information requested in the FOA.
You must also complete an Inclusion Enrollment Report (IER). Multiple IERs per study may be needed. See IER instructions.
1. Inclusion of Women and Minorities
Address these points:
- Planned subject distribution by sex/gender, race, and ethnicity.
- Rationale for selecting these groups based on scientific objectives and study design, including population characteristics of the condition.
- Proposed outreach programs for recruiting these groups.
- Justification for limiting inclusion by sex/gender, race, or ethnicity. Cost/location are generally unacceptable. See the Inclusion of Women and Minorities Policy Implementation Page.
Existing Datasets/Resources: Address inclusion if using existing data, resources, or samples, detailing sex/gender, race, and ethnicity and justifying appropriateness.
See NIH FAQs on Monitoring Inclusion with Existing Datasets.
NIH-Defined Phase III Clinical Trials: For Phase III trials, the attachment MUST address plans for considering sex/gender, race, and ethnicity in design and valid analysis. See “Valid Analysis” and “Plans to test for Differences” below.
See the NIH Inclusion of Women and Minorities Guidelines for valid analysis details.
Valid Analysis (Phase III Trials only):
Address valid analysis by:
- Using inclusive eligibility criteria (cost/location are generally not acceptable exclusion reasons).
- Randomizing allocation to intervention/control groups.
- Ensuring unbiased outcome evaluation.
- Using unbiased statistical analyses to compare intervention effects across sex/gender, race, ethnicity, especially if prior evidence suggests differences.
Plan to Test for Differences in Effect (Phase III Trials only):
Address plans to test for differences in intervention effect among sex/gender, racial, and ethnic groups, and justify whether testing is appropriate, selecting one of these analysis plans:
- Analyze for significant differences if prior studies strongly support subgroup differences.
- Include and analyze subgroups if prior studies show no significant differences (representation encouraged, but not required for selection).
- Conduct valid subgroup analyses (without high power per subgroup) if prior studies are inconclusive.
2. Inclusion of Children
Individuals of all ages are expected to be included unless scientifically or ethically unjustified. Discuss age-based exclusions and provide rationale for minimum and maximum age limits. If excluding based on age, provide scientific or ethical justification. See the NIH Inclusion Across Lifespan Policy for exclusion justifications.
- Describe investigative team expertise in working with included age ranges, facility appropriateness, and how age distribution contributes to meaningful analysis.
- When children are involved, HHS’ 45 CFR 46, Subpart D applies and must be addressed in the Protection of Human Subjects attachment.
Further Information:
See NIH resources on inclusion policies.
2.5 Recruitment and Retention Plan
Who Must Complete:
Required unless specified otherwise.
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Content:
Describe participant recruitment and retention strategies. Address planned recruitment activities and proposed engagement strategies for retention.
2.6. Recruitment Status
Who Must Complete:
Required unless specified otherwise.
Content:
Select the “Recruitment Status” from the dropdown menu that best describes the study status across all sites. Choose “recruiting” if any site is recruiting. Options include:
- Not yet recruiting
- Recruiting
- Enrolling by invitation
- Active, not recruiting
- Completed
- Suspended
- Terminated (Halted Prematurely)
- Withdrawn (No Participants Enrolled)
Note: This field matches the ClinicalTrials.gov field (Overall Recruitment Status).
2.7. Study Timeline
Who Must Complete:
Required unless specified otherwise.
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Content:
Provide a study timeline description or diagram, generally described (e.g., “one year after award”), without specific dates.
Note: More detailed timelines may be requested as just-in-time information or post-award.
2.8. Enrollment of First Subject
Who Must Complete:
Do not complete if answering “Yes” to “Using an Existing Dataset or Resource” in the Inclusion Enrollment Report.
Otherwise, required unless specified otherwise.
Content:
Enter the date (MM/DD/YYYY) of first subject enrollment and select if it is “Anticipated” or “Actual” from the dropdown.
Inclusion Enrollment Report(s) Guidance
Who Must Complete:
Required for all human subjects studies unless only Exemption 4 is selected on Question 1.3 “Exemption Number,”.
Using the Inclusion Enrollment Report:
Each study (unless under Exemption 4) needs at least one IER. Multiple IERs per study are allowed.
Edit, remove, or view added IERs as needed.
Note: IER format is not for collecting participant data.
Note: Maximum 20 IERs per Study Record, combining planned and cumulative reports.
Multi-site studies: Investigators can use one or multiple IERs for multi-site studies, based on scientific goals and monitoring needs, reporting by study or site. Non-U.S. site participants must be reported separately from U.S. participants, even within the same study. Check FOA for specific IER requirements.
Duplicative Inclusion Reports: IERs should be uniquely associated with one application and provided only once per application (e.g., not in both data coordinating center and research site applications). For linked applications, provide IERs with individual site applications unless FOA directs otherwise.
Renewal applications: Provide cumulative enrollment narrative in the research strategy progress report for renewals. Do not use IER for this. If a study continues with the same or additional enrollment, or new studies are proposed, provide new IERs.
Resubmission applications: Re-submit IERs from the initial submission, whether enrollment changed or not, and any new IERs.
Revision applications: Provide IERs if new studies are planned in the Revision and meet the NIH clinical research definition.
Additional Instructions for Multi-project Applications:
Self-contained Studies:
- Other Component: Include IER(s) with the component involving the study, unless FOA directs otherwise.
Studies Spanning Components:
- Overall Component: Include IER in the Overall Component’s Study Record and comment on associated components in the IER comment field.
Further Information:
Refer to the Inclusion of Women and Minorities Policy Implementation Page.
1. Using an Existing Dataset or Resource? (Yes/No)
Required question.
Answer “Yes” if the study only involves existing dataset or resource (e.g., biospecimens). Answer “No” for prospective recruitment or new participant contact. Use separate IERs for existing datasets/resources only and for studies with prospective recruitment.
See NIH FAQs on Monitoring Inclusion with Existing Datasets for guidance.
2. Enrollment Location Type (Domestic/Foreign)
Required field.
Select “Domestic” (U.S.) or “Foreign” (non-U.S.) enrollment site. U.S. and non-U.S. participants must be reported on separate IERs, even for the same study.
See FAQs on Inclusion by Sex/Gender and Race/Ethnicity for guidance on non-U.S. populations.
3. Enrollment Country(ies)
Optional field.
Indicate countries of participant enrollment. Multiple U.S. sites can be in one IER; foreign countries in another. Use separate IERs for U.S. and non-U.S. sites. Add up to 200 countries per IER.
4. Enrollment Location(s)
Optional field.
Indicate type of enrollment location (e.g., hospital, university), not location name.
Enrollment locations are typically where research is conducted, possibly different from recruitment sites.
5. Comments
Limited to 500 characters.
Enter relevant IER information, such as distinctive subpopulations. Indicate if inclusion monitoring is conducted on another study or grant (e.g., data coordinating center).
Revision Applications: If IERs are unchanged from the original grant, do not include IERs in the Revision application. Comment here that previous IERs are still applicable. If revising IERs, comment on this.
Additional Instructions for Multi-project Applications:
Studies Spanning Components:
- Overall Component: Include IER in the Overall Component’s Study Record and comment here on associated components.
Planned Enrollment Tables
Who Must Complete Planned Enrollment Tables:
All studies must enter planned enrollment unless using only an existing dataset/resource. Planned enrollment refers to individuals recruited or already recruited into the study.
See NIH FAQs on Inclusion by Sex/Gender and Race/Ethnicity for existing dataset/resource definitions.
See NIH Glossary for Racial Categories and Ethnic Categories.
Racial Categories
American Indian/Alaska Native:
Required fields.
Enter expected female and male counts who are American Indian/Alaska Native and Not Hispanic or Latino, and those who are American Indian/Alaska Native and Hispanic or Latino.
Asian:
Required fields.
Enter expected female and male counts who are Asian and Not Hispanic or Latino, and those who are Asian and Hispanic or Latino.
Native Hawaiian or Other Pacific Islander:
Required fields.
Enter expected female and male counts who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino, and those who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.
Black or African American:
Required fields.
Enter expected female and male counts who are Black or African American and Not Hispanic or Latino, and those who are Black or African American and Hispanic or Latino.
White:
Required fields.
Enter expected female and male counts who are White and Not Hispanic or Latino, and those who are White and Hispanic or Latino.
More than One Race:
Required fields.
Enter expected female and male counts who identify with more than one racial category and are Not Hispanic or Latino, and those who identify with more than one racial category and are Hispanic or Latino.
Total:
Totals are auto-calculated for each category and overall.
Cumulative (Actual) Enrollment Tables
Who Must Complete Cumulative Enrollment Tables:
Enter cumulative enrollment if using an existing dataset or resource.
See NIH FAQs on Inclusion by Sex/Gender and Race/Ethnicity for existing dataset/resource definitions.
See NIH Glossary for Racial Categories and Ethnic Categories.
Racial Categories
American Indian/Alaska Native:
Required fields.
Enter actual female and male counts who are American Indian/Alaska Native and Not Hispanic or Latino, and those who are American Indian/Alaska Native and Hispanic or Latino. Use “Unknown/Not Reported” fields as needed.
Asian:
Required fields.
Enter actual female and male counts who are Asian and Not Hispanic or Latino, and those who are Asian and Hispanic or Latino. Use “Unknown/Not Reported” fields as needed.
Native Hawaiian or Other Pacific Islander:
Required fields.
Enter actual female and male counts who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino, and those who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino. Use “Unknown/Not Reported” fields as needed.
Black or African American:
Required fields.
Enter actual female and male counts who are Black or African American and Not Hispanic or Latino, and those who are Black or African American and Hispanic or Latino. Use “Unknown/Not Reported” fields as needed.
White:
Required fields.
Enter actual female and male counts who are White and Not Hispanic or Latino, and those who are White and Hispanic or Latino. Use “Unknown/Not Reported” fields as needed.
More than One Race:
Required fields.
Enter actual female and male counts who identify with more than one racial category and are Not Hispanic or Latino, and those who identify with more than one racial category and are Hispanic or Latino. Use “Unknown/Not Reported” fields as needed.
Unknown or Not Reported:
Required fields.
Enter counts for females, males, and unknown/not reported sex/gender whose race is unknown/not reported and Not Hispanic or Latino; race unknown/not reported and Hispanic or Latino; and unknown/not reported race and ethnicity. Use “Unknown/Not Reported” fields as needed.
Total:
Totals are auto-calculated for each category and overall, including “Unknown/Not Reported” fields.
Section 3 – Protection and Monitoring Plans
Who Must Complete Section 3:
Section 3 is fully required for all human subjects studies unless otherwise noted.
3.1 Protection of Human Subjects
The “Protection of Human Subjects” attachment is mandatory.
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Do not use this attachment to exceed Research Strategy page limits.
For Exempt Human Subjects Research: Justify why the research meets claimed exemption criteria. Explain how the proposed research fits the exemption criteria, do not just restate criteria.
For Non-Exempt Human Subjects Research: Provide a Protection of Human Subjects attachment commensurate with study risks, size, and complexity. Organize into four sections: Risks to Human Subjects, Adequacy of Protection Against Risks, Potential Benefits, and Importance of Knowledge Gained, addressing points under each. Include any additional FOA-requested information.
1. Risks to Human Subjects
a. Human Subjects Involvement, Characteristics, and Design
- Briefly describe overall study design.
- Describe subject populations, assignment procedures, and anticipated subject numbers per group.
- List collaborating sites, their roles, and collaborating investigators.
b. Study Procedures, Materials, and Potential Risks
- Describe all research procedures (interventions/interactions), how materials (biospecimens, data, records) will be obtained, and if private identifiable information will be collected.
- For studies using previously collected materials, describe source, linkability to living individuals, and who can link materials.
- Describe all potential subject risks (physical, psychological, social, cultural, financial, legal, privacy/confidentiality, etc.). Discuss risk level and impact.
- Describe alternative treatments/procedures, including risks and benefits, and justify the proposed approach.
2. Adequacy of Protection Against Risks
a. Informed Consent and Assent
- Describe the informed consent process: circumstances, consent seekers, information provided, and consent documentation method. For adults unable to consent, describe capacity determination and plans for legally authorized representative consent.
- Justify any waivers of informed consent elements. Do not submit consent documents unless requested.
b. Protections Against Risk
- Describe strategies to protect against/minimize risks, including privacy and data confidentiality.
- Discuss plans for necessary medical/professional intervention for adverse effects.
- Describe plans for handling incidental findings (e.g., imaging, screening, paternity tests).
c. Vulnerable Subjects (If Relevant)
Explain the rationale for involving vulnerable populations (fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, etc.). ‘Prisoners’ includes all involuntarily incarcerated subjects.
Pregnant Women, Fetuses, Neonates, or Children
If involving subjects under Subparts B and D (pregnant women, fetuses, neonates, children), clearly describe risk level and additional protections needed to meet HHS regulatory requirements.
Prisoners
If involving subjects under Subpart C (prisoners), describe how research meets regulatory requirements, protections, and plans for OHRP certification.
Refer to HHS regulations and OHRP guidance.
3. Potential Benefits of the Proposed Research to Research Participants and Others
- Discuss potential research benefits to participants and others.
- Justify risk reasonableness relative to anticipated benefits.
- Note: Financial compensation should not be presented as a research benefit.
4. Importance of the Knowledge to be Gained
- Discuss the importance of knowledge gained from the research.
- Justify risk reasonableness relative to the importance of expected knowledge.
Further Information:
See NIH resources on human subject protections.
3.2 Is this a multi-site study that will use the same protocol at more than one domestic site? (Yes/No/N/A)
Select “Yes,” “No,” or “N/A.” Select “N/A” only if:
- “Yes” to “Question 1.2 Is this Study Exempt?“
- Career development applicant
- Training applicant
- Fellowship applicant
“Yes” responses imply using a single IRB (sIRB) for ethical review, unless prohibited by law, regulation, or policy.
Note: NIH sIRB policy applies to domestic sites. Foreign sites in NIH-funded multi-site studies are not expected to follow this policy.
This section, 3.2, is a key study guide point. Understanding single IRB requirements is crucial for multi-site studies. Navigating this correctly ensures compliance and streamlined ethical review.
Additional Instructions for Career Development, Training, and Fellowship Applicants:
Check “N/A” as sIRB policy does not apply to these award types.
Further Information:
See NIH resources on single IRB policy.
If yes, describe the single IRB plan
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
One sIRB attachment per application is sufficient, but include a file for each study. Use unique filenames or refer to the sIRB plan in another study (e.g., “See sIRB plan in the ‘My Unique Study Name’ study.”).
Content:
The sIRB plan should include:
- Compliance with NIH Policy on sIRB for Multi-Site Research.
- If known, name of the anticipated sIRB of record.
- Confirmation that participating sites will rely on the proposed sIRB, including sites added post-award.
- Brief description of site-sIRB communication process.
- Confirmation that sites will sign authorization/reliance agreements before study initiation, clarifying roles and responsibilities.
- Identification of the institution/entity maintaining authorization/reliance agreements and communication plan records.
- Note: Do not include authorization/reliance agreements or communication plans in the application.
- Note: For delayed onset studies, include sIRB compliance information in the delayed onset study justification.
For Legal/Regulatory/Policy-Based Exceptions: Indicate sites where sIRB review is not possible due to law/policy, citing the specific law/policy/regulation.
For Compelling Justification Exceptions: Indicate sites requesting exception and provide compelling ethical/human subjects protection justifications. NIH decides on exceptions. Note: Budget must reflect sIRB costs without exception assumption.
Further Information:
See NIH resources on single IRB policy implementation.
3.3 Data and Safety Monitoring Plan
Required if “Yes” to all Clinical Trial Questionnaire questions. Optional for other human subjects research.
For non-clinical trial human subjects research: Consider including a data and safety monitoring plan if significant participant risks exist. Follow content criteria below as appropriate.
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Content:
Additional Instructions for Career Development & Fellowship Applicants (Clinical Trial Research Experience):
Include only:
- Names of individuals/group responsible for trial monitoring (lead clinical trial investigator).
- If applicable, name of independent safety monitor or data and safety monitoring board.
For all other clinical trials, NIH requires a DSMP commensurate with trial risks, size, and complexity. Describe the DSMP, including:
- Overall framework for safety monitoring and monitored information.
- Monitoring frequency, interim analysis plans, and stopping rules (if applicable).
- Process for managing and reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Problems (UPs) to IRB, monitoring body, awarding IC, NIH Office of Biotechnology Activities, and FDA.
- Individuals/group responsible for trial monitoring and advising the appointing entity. Monitoring options include:
- PD/PI (for low-risk, unblinded trials).
- Independent safety monitor/designated medical monitor (independent physician/expert).
- Independent Monitoring Committee or Safety Monitoring Committee (small group of experts).
- Data and Safety Monitoring Board (DSMB) (formal independent expert board, required for multi-site, risky trials, and generally Phase III trials; may be needed for Phase I/II). Describe DSMB composition without naming individuals.
Further Information:
See NIH resources on data and safety monitoring.
3.4 Will a Data and Safety Monitoring Board be appointed for this study? (Yes/No)
Required if “Yes” to all Clinical Trial Questionnaire questions. Optional for other human subjects research.
Indicate if a Data Safety and Monitoring Board (DSMB) will be appointed.
3.5 Overall Structure of the Study Team
Required if “Yes” to all Clinical Trial Questionnaire questions. Optional for other human subjects research.
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Content:
Provide an overview of study team organizational/administrative structure and function, including administrative sites, data coordinating sites, enrollment/participating sites, and testing centers. Include study team composition, key roles (medical monitor, data coordinating center), governance, and communication/reporting processes.
Note: Do not include biosketch information for study team members.
Section 4 – Protocol Synopsis
Who Must Complete Section 4:
Required if “Yes” to all Clinical Trial Questionnaire questions.
Do not complete if “No” to any Clinical Trial Questionnaire question. Inputting data in this section will cause errors and application rejection.
Additional Instructions for Research, Career Development, Training, and Fellowship Applicants (Clinical Trial Research Experience):
Do not complete “Section 4 – Protocol Synopsis.” Inputting data here will cause errors and application rejection.
4.1 Brief Summary
Enter a short, lay-language description of the clinical study, including the hypothesis. Limited to 5,000 characters (typically 2,000 characters needed).
See NIH’s Rules for Text Fields for formatting.
Note: This field matches the ClinicalTrials.gov field (Brief Summary).
4.2. Study Design
4.2.a. Narrative Study Description
Enter a narrative protocol description. Describe participant assignment and intervention delivery plans, justifying sample size and data analysis methods. For group-randomized trials, special methods are needed (see Research Methods Resources). This description should not repeat the Research Strategy.
Limited to 32,000 characters (typically 5,000 characters needed), layperson’s terms, may repeat some Research Strategy info.
Note: This field matches the ClinicalTrials.gov field (Detailed Description).
See NIH’s Rules for Text Fields for formatting.
4.2.b. Primary Purpose
Select a single “Primary Purpose” from the dropdown menu that best describes the trial:
- Treatment
- Prevention
- Diagnostics
- Supportive Care
- Screening
- Health Services Research
- Basic Science
- Device Feasibility
- Other (describe if selected, 255 character limit)
Note: This field matches the ClinicalTrials.gov field (Primary Purpose).
4.2.c. Interventions
Complete “Interventions” fields for each intervention in your protocol. For study arms with multiple interventions, complete for each intervention. Add up to 20 interventions.
Intervention Type: Select from dropdown: Drug, Device, Biological/Vaccine, Procedure/Surgery, Radiation, Behavioral, Genetic, Dietary Supplement, Combination Product, Diagnostic Test, Other.
Name: Enter intervention name (200 character limit).
Description: Enter intervention description (1,000 character limit).
Note: This field matches ClinicalTrials.gov fields (Interventions).
See FAQs on Applying Electronically for behavioral research trial guidance.
4.2.d. Study Phase
Select a “Study Phase” from the dropdown menu: Early Phase 1, Phase 1, Phase 1/2, Phase 2, Phase 2/3, Phase 3, Phase 4, Other (describe if selected, 255 character limit). Use “Other” for device or behavioral interventions.
Is this an NIH-defined Phase III clinical trial? (Yes/No)
Indicate if it’s an NIH-defined Phase III clinical trial. Device/behavioral intervention studies can select “Yes” even if phase is “Other.”
See FAQs on Applying Electronically for device/behavioral intervention guidance.
4.2.e. Intervention Model
Select a single “Intervention Model” from the dropdown menu: Single Group, Parallel, Cross-Over, Factorial, Sequential, Other (describe if “Other,” 255 character limit).
Note: This field matches the ClinicalTrials.gov field (Interventional Study Model).
Further information: See ClinicalTrials.gov Glossary or Study Design description.
4.2.f. Masking
Indicate if the protocol uses masking (“blinding”).
If “Yes,” select masking types: Participant, Care Provider, Investigator, Outcomes Assessor.
Note: This field matches the ClinicalTrials.gov field (Masking).
4.2.g. Allocation
Select a single “Allocation” from the dropdown: N/A (e.g., single-arm trial), Randomized, Non-randomized.
Note: This field matches the ClinicalTrials.gov field (Allocation).
4.3. Outcome Measures
Complete “Outcome Measures” for each primary, secondary, and other important measure. Up to 50 outcome measures allowed.
Name: Enter unique outcome measure name per Study Record.
Type: Select from dropdown: Primary, Secondary, Other.
Time Frame: Indicate collection time (e.g., baseline, post-treatment).
Brief Description: Describe outcome measure metric if not in the name (999 character limit).
NIH-Defined Phase III Clinical Trials: Include outcomes for sex/gender, race, and ethnicity analyses.
See NIH Inclusion of Women and Minorities Guidelines for valid analysis details.
Note: This field matches ClinicalTrials.gov fields (e.g., Primary Outcome Measure Information).
Further Information:
See ClinicalTrials.gov resources for outcome measure guidance.
4.4. Statistical Design and Power
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Content:
Specify expected enrollment, effect size, power, and statistical methods for each Outcome Measure.
Justify sample size and data analysis methods based on participant assignment and intervention delivery plans. For group-randomized trials, special methods are needed (see Research Methods Resources).
4.5 Subject Participation Duration
Enter time (e.g., months) for individual participant study completion. Use “unknown” or “not applicable” if needed. Limited to 255 characters.
4.6 Will the study use an FDA-regulated intervention? (Yes/No)
Indicate if the study uses an FDA-regulated intervention (see definition under Oversight in ClinicalTrials.gov Protocol Registration Data Element Definitions).
4.6.a. If yes, describe Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status:
Required if “Yes” to “FDA-regulated intervention?”.
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
Typical attachment length: approximately 3,000 characters.
Content:
Summarize study agent availability and acquisition/administration support.
Indicate IND/IDE status, including exemption from IND/IDE requirements. Note any FDA interactions. If IND/IDE number exists, provide it.
Do not include IND/IDE application, manufacturer specs, protocol, or amendments.
FOA may request additional information like FDA letters.
Note: Awarding component may consult FDA and IND/IDE sponsor post-review, pre-award.
4.7 Dissemination Plan
Format:
Attach as a PDF file, following NIH’s Format Attachments guidelines.
One Dissemination Plan per application is sufficient, but include a file for each study. Use unique filenames or refer to the plan in another study (e.g., “See Dissemination Plan in the ‘My Unique Study Name’ study.”).
Content:
Briefly explain your plan for disseminating NIH-funded clinical trial information, ensuring:
- Clinical trial registration and results submission to ClinicalTrials.gov per policy and timelines.
- Informed consent documents include a statement on ClinicalTrials.gov posting.
- Recipient institution has an internal policy for compliant registration and reporting.
Note: Do not include informed consent documents in the Dissemination Plan.
Note: For Delayed Onset studies, include the Dissemination Plan in the delayed onset study justification.
Further Information:
See NIH resources on clinical trial information dissemination policy.
Section 5 – Other Clinical Trial-related Attachments
Who Must Complete Section 5:
If “Yes” to all Clinical Trial Questionnaire questions, include attachments only if requested/permitted by FOA. Otherwise, do not include attachments.
Do not complete if “No” to any Clinical Trial Questionnaire question. Inputting data here will cause errors and application rejection.
Additional Instructions for Research, Career Development, Training, and Fellowship Applicants (Clinical Trial Research Experience):
Do not complete “Section 5 – Other Clinical Trial-related Attachments.” Inputting data here will cause errors and application rejection.
5.1 Other Clinical Trial-related Attachments
Format:
Attach as PDF files, following NIH’s Format Attachments guidelines.
Maximum 10 PDF attachments in this section.
Content:
Provide additional trial-related information only if specifically requested by your FOA. Include only FOA-requested attachments, using requested filenames. If no filename is given, use a meaningful filename for application bookmarking.
