Submissions To ClinicalTrials.gov
Which clinical investigations or trials must be registered?
Trials that must be registered under the U.S. Food and Drug Administration Amendments Act of 2007 (FDAAA or “the Act”) are called “Applicable Clinical Trials (ACTs)”.
Under the statute, these trials generally include*:
- Trials of Drugs and Biologics: Controlled clinical investigations of a health outcome using a drug or biological product subject to U.S. Food and Drug Administration (FDA) regulation, other than Phase 1 clinical investigations; and
- Trials of Devices: Prospective clinical investigations of a health outcome involving a medical device subject to FDA regulation, other than a small feasibility or device prototype study. Pediatric post-market surveillance is also considered an ACT; and
- Trials funded by National Institutes of Health (NIH).
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 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 ORRAClinicalTrials-govadmin@uams.edu 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.
In what other ways does FDAAA affect UAMS Investigators?
FDA has the authority to enforce compliance with 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, NIH will post a notice describing the infractions on the registry data bank. FDA 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 (adjustable with inflation). After 30 days of notification, uncorrected violations could incur additional $10,000 (adjustable with inflation) daily penalties until the violation is corrected.
Please refer to the links below for more information.
Staff Contact
ORRAClinicalTrials-govAdmin@uams.edu
Links
- Federal Register Notice: Department of Health and Human Services (DHHS) Final Rule
- U.S. Public Law 110-85
- Food and Drug Administration Amendments Act of 2007
- Federal Register Notice: National Institutes of Health (NIH) Policy
- FDAAA 801 and the Final Rule
- Data Element definitions for ClinicalTrials.gov
- Result Element definitions for ClinicalTrials.gov
- Summary of Results Information Required by ClinicalTrials.gov
- Decision Tree for ClinicalTrials.gov Study Registration – Results