Guidelines for Registering a Clinical Trial

What Is the Definition of a Clinical Trial for Registration Purposes?

Three similar definitions of a "clinical trial" are provided below. If your study meets any one of these definitions, the trial should be registered.

The FDA (Food and Drug Administration) requires registration for "applicable clinical trials" defined as follows:

  • For any trials of drugs and biologics: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation.
  • For trials of biomedical devices: controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.

The ICMJE (International Committee of Medical Journal Editors) definition of a clinical trial includes:

  • Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

The NIH defines a clinical trial as:

  • A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)

Read the guidelines here (PDF)