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HHS Releases Final Rule for Clinical Trial Information Reporting

September 27, 2016

HHS issued a rule requiring that sponsors of certain clinical trials register and submit results to ClinicalTrials.gov, a public database operated by the National Library of Medicine.

The final rule increases the requirements for submitting registration and results information, and includes FDA-regulated investigational drug, biologic and device products. The rule goes into effect Jan. 18, 2017.

The rule requires submission of a copy of the full protocol to ClinicalTrials.gov, along with registration information, such as the race and ethnicity of trial participants, if available, as well as additional types of adverse events. It would apply to all clinical trials except for Phase I trials and small feasibility studies of medical devices, unless those studies receive NIH funding. — Conor Hale

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