HIGHLIGHTS
SUMMARY
As of 2014, registration in the European Union Clinical Trials Register (EU CTR) administered by the European Medicines Agency (EMA) is mandatory for all trial of any medicinal product conducted within a member state of the European Union (EU). The 2012 European Commission guideline 2012/c302/03 requires sponsors to ensure all trials registered on EU CTR disclose their results to the EMA within 12 months of trial completion; phase I trials are exempt unless they are part of a pediatric investigation plan. The authors aimed to identify trial characteristics associated with timely publication . . .
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