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