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Clinical Trials Registration

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

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 in the Administrative Guide defines which studies on campus must be registered in the ClinicalTrials.gov database.

*The FDA defines a clinical investigation as any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Purely observational studies are exempt from registration requirements.

  • Professional Publication – ICMJE guidelines currently define a clinical trial as, “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”  NIH encourages registration of ALL trials whether required under the law or not, and ICMJE advises that those who are uncertain whether their trial meets the ICMJE definition of eligible trials should err on the side of registering if they wish to seek publication in an ICMJE journal. See ICMJE FAQs

Who is responsible for registering trials on ClinicalTrials.gov?

The entity responsible for registering is the “responsible party.”  The statute defines the responsible party as:

(1) the sponsor of the clinical trial (as defined in 21 CFR  50.3)

-or-

(2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.” See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).

Elaborations of these definitions can be found here.

Steps for registering and “releasing” your clinical trial through University of Arkansas for Medical Sciences

Maintenance

Per the Act, the party responsible for the listing (PI or Sponsor) must also include study results in the registry.Results 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 FDA Amendments Act of 2007 for more information.

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