Intend to Publish Your Human Subjects Research Findings?
You must register in clinicaltrials.gov before your study begins!
All researchers doing health outcome studies must register in clinicaltrials.gov.
The registration requirement applies to:
“…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.”
Health-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). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”
The FDA / NIH and CMS require study registration for all “applicable clinical trials”.
- UPDATE: The NIH has revised its definition of “clinical trial” as follows:
A 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.
How to Register Your USC study:
The links below provide step by step directions to register in clinicaltrials.gov
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
firstname.lastname@example.org | Phone: (323) 442-2825