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  4. Human Subjects and Clinical Trials Information Form

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:

  • Lead 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 by one of the following submission options:

See our page on Finding Forms for more helpful information.

A PDF version of the Human Subjects and Clinical Trial information form is available on the Grants.gov forms repository Link to Non-U.S. Government Site - Click for Disclaimer , but the PDF versions CANNOT be used for submission to NIH. Screenshots of individual forms are available within the Application Instructions.​

What to Include in the Form

  1. Take a video tour of the form.Link to Non-U.S. Government Site - Click for Disclaimer

Thumbnail of video frame
Update: The information in this video also applies to the FORMS-G and H version of form used for due dates on/after Jan. 25, 2022. See FORMS-G Significant Changes or FORM-H Significant Changes.

  1. Use our Annotated Form Sets for quick reference
  2. Follow all Application Instructions carefully


Related Notices

  • 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-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions
  • NOT-OD-21-119 New NIH "FORMS-G" Grant Application Forms and Instructions Available for Due Dates On or After January 25, 2018
  • NOT-OD-18-128 Grant Application Instruction Correction for the Training Grants with Human Subjects Involvement

This page last updated on: February 28, 2022

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