What is ClinicalTrials.gov?
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to clinical study information on a wide range of diseases and conditions.
Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website before they begin enrolling participants, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. Each entry may include the following:
- Trial Protocol
- Recruitment Status
- Enrollment Criteria
- Trial Location
- Contact Information
- Study Summary Results
- Outcome Measures
- Adverse Even Information
Required by law!
Section 801 of the Food and Drug Administration (FDA) Amendments Act mandates the registration with ClinicalTrials.gov of certain clinical trials of drugs (including biologics) and medical devices subject to FDA regulations for any disease or condition. More information, please review: http://clinicaltrials.gov/ct2/manage-recs/fdaaa.
Who is responsible for registering trials on ClinicalTrials.gov?
NIH Identification of Responsible Party
What trials must be registered on ClinicalTrials.gov?
NIH Identifying Applicable Clinical Trial(s)
Required for Journal Publications:
The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial. http://www.icmje.org/faq_clinical.html
For more information regarding ClinicalTrials.gov, please review the following:
ClinicalTrials.gov Inquiries at the University of Utah
University of Utah PRS Administrator for ClinicalTrials.gov
Kristin Kolsch, FDA Clinical Research Compliance Officer
General Inquiries for ClinicalTrials.gov
Bernie LaSalle, Operations Director,
CCTS Biomedical Research Informatics Service Core*
*Costs vary depending on the type of support required and the availability of data for the report summary tables. Please contact Bernie LaSalle to discuss your support request.
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