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Tag Archives: enforcement of reporting requirements

A Patch? YES – A Fix? NO: This Emperor Has No Clothes

Posted on September 21, 2016 by Harald — No Comments ↓

The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes→

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Posted in Recent Literature, The News, The Viewpoint | Tagged Allphase Pharma Consulting, antibiotic blog, clinical trials registration and results information submission, clinicaltrials.gov, compliance with regulations, enforcement of reporting requirements, FDA, Harald Reinhart, HHS, NIH, penalties for non-compliance, reporting of trial results, studies without publications | Leave a reply

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