Clinical Trial Definitions

Registration at ClinicalTrials.gov is required for trials that meet the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 801 definition of an “Applicable Clinical Trial”, which includes the following:

1. Controlled clinical investigations (other than phase 1 investigations) of any U.S. Food and Drug Administration (FDA)-regulated drug or biological product for any disease or condition.
2. Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required pediatric post-market surveillances of a device product.

Applicable clinical trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:

• The trial has one or more sites in the United States;
• The trial is conducted under an FDA investigational new drug application or investigational device exemption;
• The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

An NIH funded research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

NIH applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials.

The NIH has special considerations for Training, Fellowship, and Career Development Awards. Please see below:

• Institutional Training awards do not support clinical trials (with the exception of some D43 and K12 awards).
• The NIH encourages fellows to receive training in clinical research, however, NIH supported fellows are not permitted to conduct a clinical trial independently.
• Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the FOA.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

A federally funded research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.