Clinical Trials
Clinical Trial Guidelines
This page is meant to help researchers and staff prepare NIH applications that involve Clinical Trials. If you are unsure if your study constitutes a clinical trial, please complete the NIH questionnaire. Ensure that your FOA allows clinical trials here.
Guidelines and templates for the individual components that must be attached or filled out via text field are provided below.
- Conditions or Focus of Study (text field, required)
- Eligibility Criteria (text field, required)
- Inclusion of Individuals Across the Lifespan (attachment, required)
- Inclusion of Women and Minorities (attachment, required)
- Recruitment and Retention Plan (attachment, required)
- Study Timeline (attachment, required)
- Inclusion Enrollment Reports (required)
- Protection of Human Subjects (attachment, required)
- Single IRB (sIRB) Plan (attachment, required if applicable for AHRQ applications only)
- Data and Safety Monitoring Plan (attachment, required)
- Overall Structure of the Study Team (attachment, not required)
- Detailed Description (text field, required)
- Interventions (text field, required)
- Study Phase (drop-down, required)
- Outcome Measures (text field, required)
- Statistical Design and Power (attachment, required)
- FDA-regulated Interventions (attachment, required if applicable)
- Dissemination Plan (attachment, required)
Download our Clinical Trials Collection Form
Our collection form helps you compile all documentation required for your clinical trials application, all in one Word document.