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This page provides key resources, policy information, and practical guidance for investigators, applicants, and recipients to help navigate NIH clinical trial requirements from study planning and funding through conduct, reporting, and dissemination of results.
Your human subjects study may meet
the NIH definition of a clinical trial.
NIH's Definition of a Clinical Trial
Learn more about the NIH definition of a clinical trial, and access the available tools and resources.
Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving Humans?
Learn how to determine whether your project is a clinical trial, basic experimental study involving humans (BESH), or an observational study involving humans. Check what to consider when answering the four clinical trial questions, case studies, and tips for BESH investigators.
Clinical Trial-Specific Funding Opportunities
All applicants proposing clinical trials can learn about the requirement for submitting applications through a funding opportunity designated specifically for clinical trials.
Clinical Trial-Specific Review Criteria
Specific review criteria will be used to evaluate applications proposing clinical trials or clinical trial research experience. Learn more about these review criteria.
Good Clinical Practice
All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials can learn about the requirement to be trained in Good Clinical Practice (GCP).
Human Subjects System
Learn more about the Human Subjects (HSS) module. HSS consolidates human subjects and clinical trial information in one place. PD/PIs, signing officials, and NIH staff access the HSS through eRA Commons.
Human Subjects and Clinical Trial Information Form
The Human Subjects and Clinical Trial Information form is required for all human subjects and/or clinical trial research. Learn more about this form and tips for completing it.
ICO Clinical Trial Funding Considerations and Contacts
This page provides ICO-specific interest areas, types of trials supported, and other funding considerations related to Clinical Trials.
Posting Clinical Trial Informed Consent Forms
Learn more about the requirement that recipients post clinical trial informed consent forms on a public federal government website.
Protocol Templates for Clinical Trials
Discover our protocol templates with instructional and sample text to help write clinical protocols for the following types of research: 1) Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications, and 2) Behavioral and social sciences research involving humans.
Requirements for Registering & Reporting NIH-Funded Clinical Trials
All NIH-funded clinical trials are expected to register and submit results information to ClinicalTrials.gov. Learn more about what you need to know about these requirements.
Information about NIH Clinical Trial Stewardship
Learn why clinical trial policies are key to enhancing the stewardship of clinical trials.
Training & Resources for NIH Clinical Trial Policies
Learn about training opportunities and find helpful resources on NIH's clinical trial policies.