Human Subjects and Clinical Trials Information Form

The PHS Human Subjects and Clinical Trials Information Form is used to collect information on:

  • human subjects research
  • clinical research and/or clinical trials
  • study population characteristics
  • protection and monitoring plans
  • protocol synopsis

Purpose

The PHS Human Subjects and Clinical Trial Form consolidates human subjects, inclusion enrollment, and clinical trial information into one place. The form:

  • Leads applicants through the human subject and clinical trial information collection requirements.
  • Expands the use of discrete form fields to capture clinical trial information to provide the level of detail needed for peer review.
  • Presents key information to reviewers and agency staff in a consistent format.
  • Aligns with ClinicalTrials.gov (where possible) and allows data exchange with ClinicalTrials.gov.

Where to Find the Form

There is not a universal form set available for download that can be used to submit a grant application to NIH. All application forms must be accessed, prepared, and submitted through one of the following options:

 
Tip
Learn about grant application Standard Form 424 (Research & Related). 

A PDF version of the Human Subjects and Clinical Trial information form is available in the Forms Directory: Standard Form 424 (Research & Related) and on the Grants.gov forms repository , but the PDF versions cannot be used for submission to NIH. Find screenshots of individual forms within the Application Instructions.

What to Include in the Form

  1. Carefully follow the G.500 - PHS Human Subjects and Clinical Trials Information instructions and all other Application Instructions.
  2. Use our Annotated Form Sets for quick reference.
  3. Take a video tour of the form.
PHS Human Subjects and Clinical Trials Information Form Walk-through | 6:08

The video tour shows the FORMS-F version. The information described also applies to the FORMS-H version used for due dates on or after Jan. 25, 2022. For details on version updates, refer to Forms-G Significant Changes (PDF), Forms-H Significant Changes (PDF), and Forms-I Significant Changes.

Related Notices

  • NOT-OD-24-086, New NIH "FORMS-I" Grant Application Forms and Instructions Coming for Due Dates on or After January 25, 2025
  • NOT-OD-22-195, New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or After January 25, 2023
  • NOT-OD-21-169, New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or After January 25, 2022
  • NOT-OD-20-026, New NIH "FORMS-F" Grant Application Forms and Instructions Coming for Due Dates on or after May 25, 2020
  • NOT-OD-18-128, Grant Application Instruction Correction for the Training Grants with Human Subjects Involvement
  • NOT-OD-17-062, New NIH "FORMS-E" Grant Application Forms and Instructions
This page last updated on: September 10, 2024
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