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Registering and Reporting Results of Clinical Trials on

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.

What is a clinical trial?

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.”

Where should a clinical trial be registered? is the registry required by the FDA Amendments Act of 2007.

Who is responsible for registering a clinical trial?

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

Who is responsible for registering in a multi-site study?

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.

What are the penalties for failure to register?

Penalties are significant and may include civil monetary penalties for investigator sponsors and, for federally-funded trials, the withholding or recovery of grant funds.

When must you register a clinical trial?

All clinical trials must be registered prior to any participants being enrolled in the study.

What is the process for registering a clinical trial?

  • Create a user account
    An individual user account in is required. To establish this account, email the Office of Clinical Trials providing the PI's name and email address. The request will be posted to and the PI will receive an email from providing his/her login and temporary password.
  • Enter study information
    The PI or the PI's designee will enter specific required information about the study. ICMJE considers a registration data set inadequate if it has missing fields or fields that contain uninformative terminology.
  • Update study information as required
    The PI is responsible for maintaining the accuracy of the information on the registered trial and meeting all applicable deadlines. This includes updating the information as appropriate, noting when enrollment ceases and entering results as applicable.

Results reporting

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 on the website.

Additional information

More information is available at the following external sites: