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:

• ASSIST ​
• Institutional Solutions (System-to-System, S2S)
• Grants.gov Workspace

A PDF version of the Human Subjects and Clinical Trial information form is available 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.

Note: 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 and Forms-H Significant Changes.

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-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: February 28, 2022