Articles with "compliance mandatory" as a keyword



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Compliance on Mandatory Data Reporting in Registered Obstetrics Trials

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Published in 2018 at "American Journal of Perinatology"

DOI: 10.1055/s-0038-1642620

Abstract: Background The Food and Drug Administration's (FDA's) Amendments Act established a legal mandate requiring registration of certain drug, device, and biologics trials in ClinicalTrials.gov prior to patient enrollment. One provision of the act requires investigators… read more here.

Keywords: reporting; clinicaltrials gov; compliance; compliance mandatory ... See more keywords