NIH requirements

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. 

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. 

CT Collection Form (WORD)