Registering a study to Clinicaltrials.gov
Health outcome studies must be registered in clinicaltrials.gov
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 clinicatrials.gov:
- NIH Definition of Clinical Trial Decision Tree
- HHS requirement for study registration
- 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
email@example.com | Phone: (323) 442-2825