As a condition for publication of trial results, the International Committee of Medical Journal Editors (ICMJE) requires all clinical research studies be entered in a public registry at or before the onset of subject enrollment.
For additional information, please see the NIH Fact Sheet released on Registration of ClinicalTrials.gov as required by Public Law 110-85, Title VIII.
NIH defines a clinical trial as: “A biomedical or behavioral research study or postmarket surveillance study of human participants designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Clinical Trials That Must be Registered at ClinicalTrials.gov - FDA Amendments Act (Title VIII, Sec. 801) (“Applicable Clinical Trials”)
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.
To register an individual investigator initiated 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:
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