For clinical trial applications submitted on or after May 25, 2020, the new NIH “FORMS-F” Grant Application Forms and Instructions is required in your application package. This form includes substantive changes such as new/deleted/modified fields. It also:
- Consolidates human subjects, inclusion enrollment, and clinical trial information into one form.
- Collects information at the study-level.
- Uses discrete form fields to capture clinical trial information and provide the level of detail needed for peer review.
- Presents key information to reviewers and staff in a consistent format.
- Aligns with ClinicalTrials.gov (where possible) for future data exchange.
Applicants should refer to Research Instructions for NIH and Other PHS Agencies (Forms Version F) for application instructions and a better understanding of where research information should be presented in the application package. Example:
Note for Applications Proposing the Involvement of Human Subjects and/or Clinical Trials:
- Use the Research Strategy section to discuss the overall strategy, methodology, and analysis of your proposed research, but do not duplicate information collected in the PHS Human Subjects and Clinical Trials Information form.
- The PHS Human Subjects and Clinical Trials Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans, and statistical design and power.
- You are encouraged to refer to information in the PHS Human Subjects and Clinical Trials Information form as appropriate in your discussion of the research strategy (e.g., see Question 2.4, Inclusion of Women, Minorities, and Children).
Please note that the new Human Subjects and Clinical Trial Form has additional attachment requirements (e.g., study timeline, statistical design and power) for all clinical trial applications.
Additional Requirements for U01 Applications
If you are submitting an application for the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) PAR-21-064, follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide AND include additional information as instructed in the Funding Opportunity Announcement (FOA). These include additional information/details specified in sections of the Human Subjects and Clinical Trials Information form (Section IV.2: Application and Submission Information: Content and Form of Application Submission), such as:
- Section 2.5 Recruitment and Retention Plan: Proactive recruitment strategy for involving underrepresented minority participants, as applicable and justified by the scientific goals.
- Clinical trials with Food and Drug Administration (FDA) oversight, e.g., Investigational New Drug (IND)/Investigational Device Exemption (IDE), also require:
- Section 4.5: Documentation of IND/IDE status if the study will use an FDA-regulated intervention.
- Section 5.1: Other clinical trial-related attachments: An Independent Data Quality Auditing Plan.
Although a clinical trial protocol is not required or allowed as an attachment to the application package, a full clinical trial protocol and informed consent will be required and subject to review and acceptance by the NIDCD at the time of funding. It is expected that protocols for funded U01 clinical trials will use the Clinical Trial Protocol Template for Phase II and III IND/IDE Studies developed by the FDA and NIH. See Section VI.2: Award Administration Information-Cooperative Agreement Terms and Conditions of Award of the FOA for details.