New HHS rule and NIH policy affecting clinical trials

DHHS and the NIH have released a new regulation and policy that affect registration and results reporting for clinical trials. The DHHS regulation, known as the Final Rule, describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov.

A complementary NIH policy applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule. Both the NIH policy and the Final Rule took effect January 18, 2017.

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