As a condition for publication, the International Committee of Medical Journal Editors (ICMJE) requires all clinical research studies be entered in a public registry at or before the first participant is enrolled.
NIH defines a clinical trial as: “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.”
ICMJE defines a clinical trial as, “Any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.”
ClinicalTrials.gov is the registry required by the FDA Amendments Act of 2007.
The "Sponsor" of the applicable clinical trial
The principal investigator of the applicable clinical trial that is investigator initiated or if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial and has sufficient data rights. The Medical Center is a registered Sponsor at Clinicaltrials.gov.
For studies being conducted at multiple study sites, a Central Contact (PI or other study official) should be designated to take primary responsibility for entering information from all of the study sites.
Penalties are significant and may include civil monetary penalties for investigator sponsors and, for federally-funded trials, the withholding or recovery of grant funds.
All clinical trials must be registered prior to any participants being enrolled in the study.
The sponsor or principal investigator is responsible for posting study results at the conclusion of the study. Detailed instructions for submission of “basic results” may be found at http://prsinfo.clinicaltrials.gov/fdaaa.html
More information is available at the following sites: