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U.S. Department of Health & Human Services | National Institutes of Health

Human Subjects and Clinical Trials Information Form

For clinical trial applications submitted on or after May 25, 2020, completion of the Human Subjects and Clinical Trials Form is required in your application package. This form includes substantive changes such as new/deleted/modified fields. It also:

  • Consolidates human subjects, inclusion enrollment, and clinical trial information into one form.
  • Collects information at the study level.
  • Uses discrete form fields to capture clinical trial information and provide the level of detail needed for peer review.
  • Presents key information to reviewers and staff in a consistent format.
  • Aligns with ClinicalTrials.gov (where possible) for future data exchange.

Applicants should refer to Research Instructions for NIH and Other PHS Agencies for application instructions and a better understanding of where research information should be presented in the application package. Example:

Note for applications proposing the involvement of human subjects and/or clinical trials:

  • Use the Research Strategy section to discuss the overall strategy, methodology, and analysis of your proposed research, but do not duplicate information collected in the PHS Human Subjects and Clinical Trials Information form.
  • The PHS Human Subjects and Clinical Trials Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans, and statistical design and power.
  • You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials Information form as appropriate in your discussion of the research strategy.

Please note that the new Human Subjects and Clinical Trial Form has additional attachment requirements (e.g., study timeline, statistical design and power) for all clinical trial applications.

Additional Requirements for U01 Applications

If you are submitting an application for the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) PAR-25-343, follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide AND include additional information as instructed in the funding opportunity. See Section IV: Application and Submission Information of the funding opportunity for details. These include the requirements below:

  • R&R or Modular Budget Section: Budget for human subjects research component award is on a capitation basis.
  • Section 2.7 Timeline: Milestones for completion of the clinical trial as well as contingency plans should there be delays need to be included. These milestones will be negotiated at the time of the award.
  • Section 3.1.3 Potential Benefits of the Proposed Research: Must provide a discussion of studies that led to the proposed clinical trial and information or data from preliminary studies which address the need for, safety and the feasibility of the trial as well as evidence of the potential efficacy for each proposed intervention. This includes pertinent results for preliminary studies which justify the specific intervention dose selection, and administration method and schedule.
  • Section 3.5 Overall Structure of the Study Team: The study statistician and data manager should be included as key personnel. In addition, clinical trial coordination staff should be delegated for the overall project management and coordination of the clinical trial to ensure completion of pre-implementation requirements and enrollment meet timeline goals; data quality and integrity; conformance to implementing the Manual of Procedures (MOP); quality assurance and control; safety monitoring and reporting.
  • Section 4.1 Study Design: Provide justification and support for selection of primary endpoint(s) as the most appropriate to inform future studies and to advance the intervention into clinical practice (clinical relevance, acceptance by regulatory authorities (e.g., FDA) and clinical community (e.g., compared with gold standard), validity, and reliability of the measurement.
    • Review Criteria Specific to this NOFO:
      Evaluate whether the selected primary endpoint(s) is validated, clinically meaningful, and the most appropriate measurement(s) to advance the intervention into practice. For the proposed intervention indication, evaluate how the selected primary endpoint(s) compares to the gold standard and whether the selected primary endpoint(s) is commonly utilized to seek FDA approval. Evaluate the likelihood that the selected primary endpoint(s) will be accepted by the clinical community. Evaluate whether research results with the selected primary outcome(s) will inform clinical decisions and lead to change in clinical practice, community behaviors, and/or health care policy. Evaluate whether the selected effect size of the primary endpoint(s) is clinically meaningful.
  • Section 4.5 FDA Documentation: If the intervention is a drug, biologic, or device, applications must contain documentation of the clinical trial protocol approval from the FDA as specified in this section. Applications that lack required documentation are considered incomplete and will not be reviewed.
  • Section 5.1 Other Clinical Trial-Related Attachments: The following additional attachments are required:
    • Trial Management Plan: ONLY for multi-site clinical trials.
    • An Independent Data Quality Auditing Plan: ONLY for Phase II, III, or IV clinical trials.
    • Post-Trial Transition Plan for Participants: Required for all applications.

Although a clinical trial protocol is not required or allowed as an attachment to the application package, a full clinical trial protocol and informed consent will be required and subject to review and acceptance by NIDCD if the clinical trial is funded. It is expected that protocols for funded U01 clinical trials will use the Clinical Trial Protocol Template for Phase II and III IND/IDE Studies developed by the FDA and NIH. See Section VI.2: Award Administration Information - Cooperative Agreement Terms and Conditions of Award of the funding opportunity for details.

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