European survey on national harmonization in clinical research

• Autor(a) principal: Magnin, Annette
• Data de Publicação: 2020
• Outros Autores: Iversen, Valentina Cabral, Calvo, Gonzalo, Čečetková, Beata, Dale, Ola, Demlová, Regina, Blaskó, György, Keane, Fionnuala, Kovacs, Gabor L., Levy‐marchal, Claire, Monteiro, Emilia C., Palmisano, Lucia, Pella, Daniel, Portolés, Antonio, Rascol, Olivier, Schmid, Caecilia, Tay, Fabian, Leyen, Heiko, Ohmann, Christian
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10362/99134
• topic: clinical research; clinical study; clinical trial; ECRIN; EU 536/2014; harmonization of processes; survey

Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials through-out the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. Methods: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized