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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 FDA regulation; and
  • Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance; and
  • Trials funded by NIH 

Trials that must be registered as a requirement by the Center for Medicaid  & Medicare (CMS) include:

  • Clinical trials, clinical studies, or registries that are qualified for coverage as specified in the Medicare National Coverage Determination (NCD) 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 database and who is responsible for registering and maintaining the trials on

Find elaborations of these definitions on the website.

Registration and Maintenance

In addition to regular (at least annual) verification of the study record, study results are required and must be submitted within 1 year of the Primary Completion Date.

How else does the FDA Amendments Act of 2007 affect University of Arkansas for Medical Sciences Investigators?

The FDA 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 NIH will post a notice describing the infractions on the registry data bank. The 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. 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.

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