Registering a study to

Health outcome studies must be registered in
This requirement applies to:

  • All NIH-funded trials such as phase 1 studies or clinical trials of behavioral interventions or non-FDA-regulated products.
  • Clinical trials involving FDA-regulated drug, biologic and device products
  • Any study intended for publication in a journal recognized by the ICMJE

Behavioral interventions are sometimes clinical trials

The Dept of Health and Human Services defines clinical trials as:

“…any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions1 to evaluate the effects on health outcomes2.”

1Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).
2Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”

FDA regulated studies are clinical trials

The FDA / NIH and Centers for Medicare/Medicaid (CMS) require study registration for all “applicable clinical trials”.

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

How to register your USC study to

Registration Steps
Requirements Summary
Responsible Party

Helpful Links

NIH Definition of Clinical Trial Decision Tree
HHS requirement for study registration[page not found]
Journal requirement for study registration
Recommendation for study registration (USC Vice President of Research)

If you are uncertain of whether to register your clinical trial, err on the side of caution and register your study.

Jean Chan can help with registration questions and applicability of your study
  |  (323) 442-2825