Submissions To ClinicalTrials.gov
Which clinical investigations or trials must be registered?
Trials that must be registered under the Act are called “applicable clinical trials.” Under the statute, these trials generally include:
- Trials of Drugs and Biologics: Controlled, *clinical investigations, other than Phase 1 investigations, of a product subject to Food and Drug Administration regulation; and
- Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance; and
- Trials funded by National Institutes of Health
Trials that must be registered as a requirement by the Centers for Medicare & Medicaid Services include:
- Clinical trials, clinical studies, or registries that are qualified for coverage as specified in the Medicare National Coverage Determination Manual, Section 310.1, and in which claims for items and/or services associated with the clinical investigation could potentially be submitted to Medicare Contractors.
*UAMS Policy 16.1.18 (see below) defines which studies on campus must be registered in the ClinicalTrials.gov database and who is responsible for registering and maintaining the trials on ClinicalTrials.gov.
Find elaborations of these definitions on the ClinicalTrials.gov website.
Registration and Maintenance
- Contact the UAMS ClinicalTrials.gov Administrators at ORRAClinicalTrialsfirstname.lastname@example.org to request a new user account, if you are new to using the ClinicalTrials.gov database.
- Access the Protocol Registration and Results System website.
In addition to regular (at least annual) verification of the study record, study results are required and must be submitted within one year of the Primary Completion Date.
How else does the Food and Drug Administration Amendments Act of 2007 affect UAMS Investigators?
The Food and Drug Administration has the authority to enforce compliance to these clinical trial registry requirements put forth by the Act. If a sponsor fails to register any trial which meets the eligibility criteria, fails to submit trial results, or submits false data or information, the National Institutes of Health will post a notice describing the infractions on the registry data bank. The Food and Drug Administration is also authorized to impose monetary penalties for failure to comply with the requirements of the Act.
Any person who violates the provisions of the Act will be subject to penalties up to $10,000. After 30 days of notification, uncorrected violations could incur additional $10,000 daily penalties until the violation is corrected.
Please refer to the links below for more information.
- Federal Register Notice: HHS Final Rule
- U.S. Public Law 110-85
- Food and Drug Administration Amendments Act of 2007
- Federal Register Notice: National Institutes of Health Policy
- International Committee of Medical Journal Editors FAQs
- Protocol Registration and Results System and U.S. Public Law 110-85
- Data Element definitions for ClinicalTrials.gov
- Result Element definitions for ClinicalTrials.gov