Clinical Trials Registration
What is ClinicalTrials.gov?
ClinicalTrials.gov is a government operated website and database that contains the information on both federally and privately funded clinical trials. The website is maintained by the National Library of Medicine. Study sponsors and/or principal investigators provide and update all study information.
Why Do I Need to Register a Clinical Trial?
The U.S. Food and Drug Administration Amendments Act 801 (FDAA801) requires by law the registration of clinical trials on ClinicalTrials.gov to ensure transparency and full public access to all study-related research and results. Our affiliated teaching hospital, University Health, requires registration as part of their contract process for clinical trials. For simplification purposes, UMKC makes these same recommendations.
How Do I Register a Study on ClinicalTrials.gov?
Visit ClinicalTrials.gov for detailed information on how to register. Contact the School of Medicine Research Administration office for access to the School of Medicine registration group.
- Determine the responsible party
- Review submission requirements
- Log in to PRS
- Enter required and optional data
- Preview, inspect and submit the record
What Information Do I Put in the ClinicalTrials.gov Record and Results Database?
- Procedure, drug, product, disease or medical condition being investigated
- Overview of the study and contact information
- Eligibility criteria and study locations
- Subject information
- Adverse events and results
- Study outcomes
What Benefits does ClinicalTrials.gov Offer?
- Study records management
- Organization of study participant information
- Study results
- Patient and family member access: find studies by topic or location, list of frequently asked questions for participants
Clinicaltrials.gov also satisfies all publication requirements set forth by the International Committee of Medical Journal Editors (ICMJE), which includes ICMJE journals such as the Journal of the American Medical Association, New England Journal of Medicine, and The Lancet.