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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
- Carefully follow the G.500 - PHS Human Subjects and Clinical Trials Information instructions and all other Application Instructions.
- Use our Annotated Form Sets for quick reference.
- Take a video tour of the form.
PHS Human Subjects and Clinical Trials Information Form Walk-through | 6:08
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