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Tag Archives: compliance with regulations

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 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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