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New Clinical Trial Reporting Rule, Policy Toughen Enforcement

Sept. 19, 2016, 4:00 AM

The NIH may freeze future grant funding if a research institution fails to follow final clinical trial registration and reporting requirements released Sept. 16.

The potential hold is a move by the National Institutes of Health to address low compliance rates—particularly by scientists at academic institutions—for registering studies and reporting their results on ClincalTrials.gov. It’s part of the enforcement arm of an NIH final policy that expands the requirements to agency-sponsored clinical trials.

That NIH policy complements a separate but related Department of Health and Human Services final rule, which requires registration and results reporting for clinical trials ...

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