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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. This form is included in Application Packages for all due dates on or after January 25, 2018.

The form will:

  • Lead applicants through the human subject and clinical trial information collection requirements
  • Expand 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 positions the NIH for future 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 these CANNOT be used for submission to NIH. Screenshots of individual forms are available within the Application Instructions.​

How to Complete the Form

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

Thumbnail of video frame
 

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


Related Notices

  • NOT-OD-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions
  • NOT-OD-17-119 New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018
  • NOT-OD-18-128 Grant Application Instruction Correction for Training Grants with Human Subjects Involvement
This page last updated on April 30, 2018
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