What is ClinicalTrials.gov and do I have to do it?

Answer

ClinicalTrials.gov is a website resource provided by the U.S. National Library of Medicine. Federal law (42 CFR Part 11) requires that certain clinical trials are registered and provide results information on ClinicalTrials.gov. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial.

Federally-funded studies that meet the NIH definition of a clinical trial and any study (regardless of funding) that meets the FDA definition of an applicable clinical trial must be registered.  

Please review the NIH definition of clinical trial as it is not necessarily a "biomedical" experiment.

Contact OPRS to discuss the ClinicalTrials.gov process.