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:

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

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 , 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

Take a video tour of the form.

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

Use our Annotated Form Sets for quick reference
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-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