European survey on national harmonization in clinical research

Annette Magnin; Valentina Cabral Iversen; Gonzalo Calvo; Beata Čečetková; Ola Dale; Regina Demlová; György Blaskó; Fionnuala Keane; Gabor L. Kovacs; Claire Levy‐marchal; Emilia C. Monteiro; Lucia Palmisano; Daniel Pella; Antonio Portolés; Olivier Rascol; Caecilia Schmid; Fabian Tay; Heiko Leyen; Christian Ohmann

doi:10.1002/lrh2.10220

European survey on national harmonization in clinical research

Annette Magnin, Valentina Cabral Iversen, Gonzalo Calvo, Beata Čečetková, Ola Dale, Regina Demlová, György Blaskó, Fionnuala Keane, Gabor L. Kovacs, Claire Levy‐marchal, Emilia C. Monteiro, Lucia Palmisano, Daniel Pella, Antonio Portolés, Olivier Rascol, Caecilia Schmid, Fabian Tay, Heiko Leyen, Christian Ohmann

NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

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Abstract

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

Original language	English
Pages (from-to)	1-9
Journal	Learning Health Systems
DOIs	https://doi.org/10.1002/lrh2.10220
Publication status	Published - Jan 2020

Keywords

clinical research
clinical study
clinical trial
ECRIN
EU 536/2014
harmonization of processes
survey

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lrh2.10220Final published version, 211 KB

https://onlinelibrary.wiley.com/doi/abs/10.1002/lrh2.10220

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Magnin, A., Iversen, V. C., Calvo, G., Čečetková, B., Dale, O., Demlová, R., Blaskó, G., Keane, F., Kovacs, G. L., Levy‐marchal, C., Monteiro, E. C., Palmisano, L., Pella, D., Portolés, A., Rascol, O., Schmid, C., Tay, F., Leyen, H., & Ohmann, C. (2020). European survey on national harmonization in clinical research. Learning Health Systems, 1-9. https://doi.org/10.1002/lrh2.10220

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author = "Annette Magnin and Iversen, {Valentina Cabral} and Gonzalo Calvo and Beata {\v C}e{\v c}etkov{\'a} and Ola Dale and Regina Demlov{\'a} and Gy{\"o}rgy Blask{\'o} and Fionnuala Keane and Kovacs, {Gabor L.} and Claire Levy‐marchal and Monteiro, {Emilia C.} and Lucia Palmisano and Daniel Pella and Antonio Portol{\'e}s and Olivier Rascol and Caecilia Schmid and Fabian Tay and Heiko Leyen and Christian Ohmann",

year = "2020",

month = jan,

doi = "10.1002/lrh2.10220",

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journal = "Learning Health Systems",

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AU - Magnin, Annette

AU - Iversen, Valentina Cabral

AU - Calvo, Gonzalo

AU - Čečetková, Beata

AU - Dale, Ola

AU - Demlová, Regina

AU - Blaskó, György

AU - Keane, Fionnuala

AU - Kovacs, Gabor L.

AU - Levy‐marchal, Claire

AU - Monteiro, Emilia C.

AU - Palmisano, Lucia

AU - Pella, Daniel

AU - Portolés, Antonio

AU - Rascol, Olivier

AU - Schmid, Caecilia

AU - Tay, Fabian

AU - Leyen, Heiko

AU - Ohmann, Christian

PY - 2020/1

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KW - clinical study

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KW - EU 536/2014

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JO - Learning Health Systems

JF - Learning Health Systems

SN - 2379-6146

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European survey on national harmonization in clinical research

Abstract

Keywords

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