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Which Clinical Investigations or Trials Must Be Registered?

FDA Requirements

Trials that must be registered under the FDA Amendments Act of 2007 (FDAAA) are called Applicable Clinical Trials. Under the statute, these trials generally include:

  • Trials of Drugs and Biologics: Controlled, *clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation
  • Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post‐market surveillance.

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

ClinicalTrials.gov accepts registration of all clinical trials that are both approved by a human subject review board and conform to the regulations of the appropriate national health authorities. Both interventional and observational studies are accepted.

Trials can be registered at any time, but many policies require registration prior to the enrollment of the first participant. Information about these policies and background materials are available at http://prsinfo.ClinicalTrials.gov.

*The FDA defines a clinical investigation as any experiment in which a drug is administered or dispensed to, or used, and which involves one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Purely observational studies are exempt from registration requirements.

Journal Publication Requirements

An Investigator who is intending to publish his or her study in an ICMJE-associated medical journal is required to register the study if it meets the ICMJE definition of a clinical trial.

  • Health‐related interventions to evaluate the effects on health outcomes. Purely observational studies those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
  • Health outcomes include any biomedical or health‐related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
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