ClinicalTrials.gov

ClinicalTrials.gov is a Web-based resource created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was made available to the public in February 2000.

The ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trail registration information to be submitted The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database, which contains summary information on study participants and study outcome, including adverse events. The results database was made available to the public in September 2008.

What studies are required to be registered?

Applicable Clinical Trials (ACTs) are interventional studies of drugs, biologics, or devices that meet the criteria outlined in the ACT check list.

NIH Funded Clinical Trials

The National Institutes of Health (NIH) Policy on Dissemination of NIH-Funded Clinical Trial Information requires registration and results reporting, and applies to all clinical trials funded by NIH, regardless of whether they are subject to the FDAAA 801 and the Final Rule effective January 18, 2017.

ICMJE

The ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry before the time of first patient enrollment as a condition of consideration for publication.

Medicare Billing

Effective January 1, 2015, all Medicare qualifying trials, including some Phase 1 and device feasibility trials, are required to be registered into the ClinicalTrials.gov database. NCT numbers are required on clinical research related claims in order to receive payment. Patients should not be enrolled on a trial unless the NCT registration number is in place.

Resources at UH

• Dedicated point person to help with registration and results entry. For assistance please reach out to UHResearchCompliance@UHhospitals.org and someone will be in touch to offer assistance.
• Tip sheets are available in the Clinical Research Toolbox with step-by-step instructions for registration.
  • • ClinicalTrials.gov – Create an Account (PDF)
    • ClinicalTrials.gov – Register a Clinical Trial (PDF)
• Results templates are available also. For a study specific results template please email UHResearchCompliance@UHhospitals.org.
• For more information, please review ClinicalTrials.gov Standard Operating Procedures for more information.
  • • SC-401 – Registration of Clinical Trials in ClinicalTrials.gov
    • SC-406 – Results Reporting of Clinical Trials in ClinicalTrials.gov