NIH Seeks Input on Proposed Clinical Trial Application Form

Inviting Input on a Proposed Clinical Trial Specific Application Form Notice Number: NOT-OD-26-058

Key Dates

Release Date: March 18, 2026 Response Date: April 17, 2026

Related Announcements

None

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

The National Institutes of Health (NIH) seeks public input on a Proposed Clinical Trial Specific Application Form designed to streamline investigator-initiated clinical trial applications. Specifically, NIH proposes to combine components of the current Research Plan in clinical trial applications and the PHS Human Subjects and Clinical Trials Information Form into a single, consolidated form. By requiring a semi-structured application specifically designed for clinical trials, NIH aims to (1) simplify the application process for investigators and (2) improve the availability of critical information needed for the review of clinical trials.

Background

In 2025, NIH convened an internal working group composed of leaders with expertise in human subjects research and clinical trials to address persistent challenges in how clinical trials information is presented and reviewed in NIH grant applications. The working group examined longstanding concerns about inefficiencies stemming from redundancies, variability, and dispersion of required clinical trial information across multiple application components. Collectively, these challenges can obscure critical elements of trial design and conduct, increase administrative burden for applicants, and complicate the peer review process.

To better understand these issues, the working group conducted a comprehensive review of existing NIH clinical trial grant applications and widely accepted clinical trial reporting standards (e.g., CONSORT, SPIRIT), as well as relevant intramural research protocols. Based on this assessment, the working group concluded that a single, standardized clinical trial specific application form—employing a semi-structured yet flexible format—could substantially improve the clarity, consistency, and efficiency of clinical trial applications. Accordingly, the working group developed a prototype Proposed Clinical Trial Specific Application Form that integrates essential clinical trial elements currently distributed across the Research Plan in clinical trial applications and the PHS Human Subjects and Clinical Trials Information Form.

The proposed form is designed to clarify expectations for investigators, reduce redundancy, and streamline application preparation by consolidating required clinical trial information into a cohesive, organized format. Its semi-structured design is intended to accommodate a wide range of clinical trial designs, intervention types, and scientific approaches, while preserving investigators’ ability to provide study-specific details critical to understanding the proposed research. By ensuring that core clinical trial elements are presented in a clear and consistent manner, this approach has the potential to enhance the efficiency, rigor, and transparency of peer review.

Information Requested

NIH invites input on the Proposed Clinical Trial Specific Application Form (Table 1 below) from clinical trials investigators, peer reviewers, and others involved in the design, conduct, oversight, or review of NIH-supported clinical trials. Respondents are encouraged to comment on any or all of the following topics:

• Anticipated level of effort associated with the proposed form, including the estimated number of hours added to or reduced from the application process.
• Completeness of the proposed form, including any missing essential elements or additional items that would be informative.
• Conciseness of the proposed form, including elements that could be eliminated or combined.
• Proposed form structure, including page limits and the distribution of content across sections.
• Applicability of the proposed form for the entire range of clinical trial designs and interventions.
• Implications for investigators and/or research teams, including potential benefits, challenges, and/or barriers to using the proposed form.
• Implications for peer review, including potential benefits or challenges, and impacts on efficiency, quality, and consistency of review.
• Implications for institutional grants offices and research administration workflows.
• Suggested details to include in the proposed form instructional text (not included here; to be developed) that will define required application elements.
• Any additional suggestions or considerations. Proposed Form

The Proposed Clinical Trial–Specific Application Form (Table 1) consolidates required clinical trials information –- excluding the full protocol –- into a single, semi-structured format with defined sections. Required information that is currently distributed across the Research Plan and the PHS Human Subjects and Clinical Trials Information Form would be reorganized into sections aligned with peer review criteria and key aspects of clinical trial design, conduct, and oversight.

Each section of the form will be accompanied by instructions (not included here; to be developed) that define required elements and specify the recommended level of detail. These instructions will aim to promote consistent formatting, minimize duplication across sections, and facilitate efficient review by clearly identifying core clinical trials components.

The proposed form has an overall limit of 23 pages with section-specific limits designed to balance completeness and conciseness. Table 3 outlines the proposed structure, required elements, and page limits.

***** Planned enrollment forms include expected participant enrollment numbers by sex, race, and ethnicity for the full study period

| Table 1. Proposed Clinical Trials-Specific Application Form | | Proposed Page Limits |
| 1. Specific Aims (including primary and secondary objectives) | | 1-page limit |
| 2. Background and Rationale/Scientific Premise and Justification | | 12-page limit for sections 2 and 3 combined; each subsection required; "n/a" allowed |
| | a. Focus of study (or primary disease/conditions) | |
| | b. Preliminary studies | |
| | c. Potential impact on science and/or clinical practice | |
| 3. Approach | | |
| | a. Study design | |
| | b. Study setting and site(s) | |
| | c. Single vs. multi-site | |
| | d. Study intervention (type, name, description, comparator, operational capacity, availability of intervention, and quality control) | |
| | e. Eligibility criteria | |
| | f. Allocation | |
| | g. Masking | |
| | h. Outcome measures and data collection methods (primary/secondary outcomes, quality control for methods employed, and use of Common Data Elements where feasible) | |
| | i. Feasibility | |
| | 1) Recruitment plans | |
| | 2) Retention plans (including plans for addressing participant attrition) | |
| | 3) Participant timeline/burden (visit number/inpatient stays, procedures) | |
| | j. Other contingency plans (if needed) | |
| | k. Analysis plans (statistical analysis, sample size/power estimates, and plans for interim analysis, if applicable) | |
| 4. Participant Demographic Characteristics | | 1-page limit (not including planned enrollment forms) |
| | a. Sex (planned enrollment form)* | |
| | b. Minorities (planned enrollment form)* | |
| | c. Lifespan (planned enrollment form)* | |
| 5. Project Timeline | | 1-page limit |
| 6. Human Subjects Protection Plans | | 4-page limit (each subsection required; n/a allowed) |
| | a. Name of the reviewing Institutional Review Board | |
| | b. Informed consent procedures | |
| | c. Potential subject benefits and risks (including risk mitigation plans) | |
| | d. Data safety and monitoring plan | |
| | e. Regulatory (if applicable) | |
| | 1) FDA or other agency/oversight considerations | |
| | 2) IND/IDE plan for investigational product (and control) handling | |
| 7. Dissemination Plan and Data Management and Sharing Plans | | 3-page limit |
| | a. Dissemination Plan | |
| | b. Data management and sharing plans | |
| 8. Biospecimen Handling | | 1-page limit |
| ** Planned enrollment forms include expected participant enrollment numbers by sex, race, and ethnicity for the full study period* | | |

Current Forms for Comparison Purposes Only (NIH is not seeking feedback on current forms)

For comparison purposes, Tables 3 and 4 show the structure and elements of the current application forms. Under the current process, investigators must provide required clinical trial information in two separate documents: the Research Plan in clinical trial applications (Table 2) and the PHS Human Subjects and Clinical Trials Information Form (Table 3). Clinical trial elements are addressed in open-ended narrative sections, while required Planned Enrollment Reports and other information are captured separately in the PHS Human Subjects and Clinical Trials Information Form. This structure requires applicants to distribute related information across formats and locations.

| Table 2. Elements of the Current Research Plan | Current Page Limits |
| 1. Specific Aims | 1 page |
| 2. Research Strategy | 12 pages |

| Table 3. Elements of the Current PHS human Subjects and Clinical Trials Application Form (no page limit) | |
| Section 1 - Basic Information (Study #) | |
| | 1.1 Study Title |
| | 1.2 Is the study exempt from Federal Regulations? |
| | 1.3 Exemption Number |
| | 1.4 Clinical Trial Questionnaire |
| | 1.4.a. Does the study involve human participants?; 1.4.b. Are the participants prospectively assigned to an intervention?; 1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?; 1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome? |
| | 1.5. Provide the ClinicalTrials.gov Identifier (e.g. NCT87654321) for this trial, if applicable |
| Section 2 - Study Population Characteristics (Study #) | |
| | 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 reports |
| Section 3 - Protection and Monitoring Plans (Study #) | |
| | 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? (If yes, describe the single IRB plan) |
| | 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 (Study #) | |
| | 4.1 Study Design (4.1.a. Detailed Description; 4.1.b. Primary Purpose; 4.1.c. Interventions; 4.1.d. Study Phase; 4.1.e. Intervention Model; 4.1.f. Masking; 4.1.g. Allocation) |
| | 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? |
| | 4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/ Investigational Device Exemption (IDE) status |
| | 4.6. Is this an applicable clinical trial under FDAAA? |
| | 4.7. Dissemination Plan |
| Section 5 - Other Clinical Trial-related attachments | |

Submitting a Response

To ensure consideration, comments must be submitted electronically to https://rfi.grants.nih.gov/?s=6998c6f85af314d3d80c0b72 **** by April 17, 2026.

This request is for planning purposes only and does not constitute a policy, funding opportunity, or commitment by the Government. The Government will not pay for the preparation or submission of responses or for the use of the information provided.

Participation is voluntary, and comments may be submitted anonymously. You may also voluntarily include your name and contact information. Please do not include proprietary, classified, confidential, or sensitive information. All input will be considered in the refinement of the Proposed Clinical Trial Specific Application Form.

Inquiries

Please direct all inquiries to:

Unsolicited Clinical Trials Specific Application Form Working Group

National Institutes of Health

[email protected]

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