Registration for Clinical Research Trials
It is recommended that those responsible for conducting a clinical trial check to make sure they are in compliance with the trial registration requirements of the Food and Drug Administration (FDA), the International Committee of Medical Journal Editors (ICMJE), and, as needed, other organizations with policies on clinical trial registration for transparency and publication.
Section 801 of the Food and Drug Amendments Act, known as FDAAA 801, requires registration of studies meeting the definition of “Applicable Clinical Trial”* on a government web site called ClinicalTrials.gov.
The International Committee of Medical Journal Editors (ICMJE) requires, and recommends that all medical journal editors require, as a condition of consideration for publication, registration of [all] clinical trials in a public trials registry at or before the time of first patient enrollment.
Effective January 1, 2015, Center for Medicare and Medicaid Services (CMS) will require a clinical trial identifier (NCT#) be reported on all billing claims for items/ services related to a qualifying clinical trial(s). If your study will bill routine costs to Medicare or any other insurer, the study must be registered on ClinicalTrials.gov to obtain the NCT#.