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Considerations on Layperson Trial Summaries in the EU.

Authors :
Zaninelli, M.
Ornago, E.
Sala, E.
Ferrari, A.
Source :
Applied Clinical Trials; Jul/Aug2017, Vol. 26 Issue 7/8, p26-33, 6p
Publication Year :
2017

Abstract

The article focuses on the issues regarding writing and constructing layperson summaries of clinical trial results in European Union (EU). Topics discussed include European Parliament released the Regulation 536/2014 on clinical trials on medicinal products for human use, European Medicines Agency (EMA) implemented a public European database in which to collect and retrieve all relevant information on clinical trials submitted to the agency and target audience for a layperson summary.

Details

Language :
English
ISSN :
10648542
Volume :
26
Issue :
7/8
Database :
Complementary Index
Journal :
Applied Clinical Trials
Publication Type :
Academic Journal
Accession number :
124632457