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Registering and Reporting Results of Clinical Trials on ClinicalTrials.gov

IRB accreditation logo.jpgAs 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.

What is a clinical trial?

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”)

  • Trials of Drugs and Biologicals: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation
  • Trials of Devices: (a) a prospective clinical study of health outcomes comparing an intervention with a device, subject to FDA regulation, against a control in human subjects, (other than small feasibility studies), and (b) pediatric post-market surveillance

Where should a clinical trial be registered?

ClinicalTrials.gov 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

OR

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.

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?

To register an individual investigator initiated study:

  • An individual user account will need to be established at ClinicalTrials.gov by the University Administrator for the Principal Investigator (PI) of the study. Send an email to kcliburn@umc.edu providing the PI's name and e-mail address. The request will be posted to ClinicalTrials.gov and the PI will receive an e-mail from ClinicalTrials.gov providing his/her login and temporary password.
  • 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.
  • The PI is responsible for maintaining the accuracy of the information on the registered trial. 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 at http://prsinfo.clinicaltrials.gov/fdaaa.html

Additional information

More information is available at the following sites: