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Introduction to the EQIPD quality system

While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research qua...

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Autores principales: Bespalov, Anton, Bernard, René, Gilis, Anja, Gerlach, Björn, Guillén, Javier, Castagné, Vincent, Lefevre, Isabel A, Ducrey, Fiona, Monk, Lee, Bongiovanni, Sandrine, Altevogt, Bruce, Arroyo-Araujo, María, Bikovski, Lior, de Bruin, Natasja, Castaños-Vélez, Esmeralda, Dityatev, Alexander, Emmerich, Christoph H, Fares, Raafat, Ferland-Beckham, Chantelle, Froger-Colléaux, Christelle, Gailus-Durner, Valerie, Hölter, Sabine M, Hofmann, Martine CJ, Kabitzke, Patricia, Kas, Martien JH, Kurreck, Claudia, Moser, Paul, Pietraszek, Malgorzata, Popik, Piotr, Potschka, Heidrun, Prado Montes de Oca, Ernesto, Restivo, Leonardo, Riedel, Gernot, Ritskes-Hoitinga, Merel, Samardzic, Janko, Schunn, Michael, Stöger, Claudia, Voikar, Vootele, Vollert, Jan, Wever, Kimberley E, Wuyts, Kathleen, MacLeod, Malcolm R, Dirnagl, Ulrich, Steckler, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: eLife Sciences Publications, Ltd 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184207/
https://www.ncbi.nlm.nih.gov/pubmed/34028353
http://dx.doi.org/10.7554/eLife.63294
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author Bespalov, Anton
Bernard, René
Gilis, Anja
Gerlach, Björn
Guillén, Javier
Castagné, Vincent
Lefevre, Isabel A
Ducrey, Fiona
Monk, Lee
Bongiovanni, Sandrine
Altevogt, Bruce
Arroyo-Araujo, María
Bikovski, Lior
de Bruin, Natasja
Castaños-Vélez, Esmeralda
Dityatev, Alexander
Emmerich, Christoph H
Fares, Raafat
Ferland-Beckham, Chantelle
Froger-Colléaux, Christelle
Gailus-Durner, Valerie
Hölter, Sabine M
Hofmann, Martine CJ
Kabitzke, Patricia
Kas, Martien JH
Kurreck, Claudia
Moser, Paul
Pietraszek, Malgorzata
Popik, Piotr
Potschka, Heidrun
Prado Montes de Oca, Ernesto
Restivo, Leonardo
Riedel, Gernot
Ritskes-Hoitinga, Merel
Samardzic, Janko
Schunn, Michael
Stöger, Claudia
Voikar, Vootele
Vollert, Jan
Wever, Kimberley E
Wuyts, Kathleen
MacLeod, Malcolm R
Dirnagl, Ulrich
Steckler, Thomas
author_facet Bespalov, Anton
Bernard, René
Gilis, Anja
Gerlach, Björn
Guillén, Javier
Castagné, Vincent
Lefevre, Isabel A
Ducrey, Fiona
Monk, Lee
Bongiovanni, Sandrine
Altevogt, Bruce
Arroyo-Araujo, María
Bikovski, Lior
de Bruin, Natasja
Castaños-Vélez, Esmeralda
Dityatev, Alexander
Emmerich, Christoph H
Fares, Raafat
Ferland-Beckham, Chantelle
Froger-Colléaux, Christelle
Gailus-Durner, Valerie
Hölter, Sabine M
Hofmann, Martine CJ
Kabitzke, Patricia
Kas, Martien JH
Kurreck, Claudia
Moser, Paul
Pietraszek, Malgorzata
Popik, Piotr
Potschka, Heidrun
Prado Montes de Oca, Ernesto
Restivo, Leonardo
Riedel, Gernot
Ritskes-Hoitinga, Merel
Samardzic, Janko
Schunn, Michael
Stöger, Claudia
Voikar, Vootele
Vollert, Jan
Wever, Kimberley E
Wuyts, Kathleen
MacLeod, Malcolm R
Dirnagl, Ulrich
Steckler, Thomas
author_sort Bespalov, Anton
collection PubMed
description While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.
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spelling pubmed-81842072021-06-09 Introduction to the EQIPD quality system Bespalov, Anton Bernard, René Gilis, Anja Gerlach, Björn Guillén, Javier Castagné, Vincent Lefevre, Isabel A Ducrey, Fiona Monk, Lee Bongiovanni, Sandrine Altevogt, Bruce Arroyo-Araujo, María Bikovski, Lior de Bruin, Natasja Castaños-Vélez, Esmeralda Dityatev, Alexander Emmerich, Christoph H Fares, Raafat Ferland-Beckham, Chantelle Froger-Colléaux, Christelle Gailus-Durner, Valerie Hölter, Sabine M Hofmann, Martine CJ Kabitzke, Patricia Kas, Martien JH Kurreck, Claudia Moser, Paul Pietraszek, Malgorzata Popik, Piotr Potschka, Heidrun Prado Montes de Oca, Ernesto Restivo, Leonardo Riedel, Gernot Ritskes-Hoitinga, Merel Samardzic, Janko Schunn, Michael Stöger, Claudia Voikar, Vootele Vollert, Jan Wever, Kimberley E Wuyts, Kathleen MacLeod, Malcolm R Dirnagl, Ulrich Steckler, Thomas eLife Neuroscience While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union’s Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use. eLife Sciences Publications, Ltd 2021-05-24 /pmc/articles/PMC8184207/ /pubmed/34028353 http://dx.doi.org/10.7554/eLife.63294 Text en © 2021, Bespalov et al https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use and redistribution provided that the original author and source are credited.
spellingShingle Neuroscience
Bespalov, Anton
Bernard, René
Gilis, Anja
Gerlach, Björn
Guillén, Javier
Castagné, Vincent
Lefevre, Isabel A
Ducrey, Fiona
Monk, Lee
Bongiovanni, Sandrine
Altevogt, Bruce
Arroyo-Araujo, María
Bikovski, Lior
de Bruin, Natasja
Castaños-Vélez, Esmeralda
Dityatev, Alexander
Emmerich, Christoph H
Fares, Raafat
Ferland-Beckham, Chantelle
Froger-Colléaux, Christelle
Gailus-Durner, Valerie
Hölter, Sabine M
Hofmann, Martine CJ
Kabitzke, Patricia
Kas, Martien JH
Kurreck, Claudia
Moser, Paul
Pietraszek, Malgorzata
Popik, Piotr
Potschka, Heidrun
Prado Montes de Oca, Ernesto
Restivo, Leonardo
Riedel, Gernot
Ritskes-Hoitinga, Merel
Samardzic, Janko
Schunn, Michael
Stöger, Claudia
Voikar, Vootele
Vollert, Jan
Wever, Kimberley E
Wuyts, Kathleen
MacLeod, Malcolm R
Dirnagl, Ulrich
Steckler, Thomas
Introduction to the EQIPD quality system
title Introduction to the EQIPD quality system
title_full Introduction to the EQIPD quality system
title_fullStr Introduction to the EQIPD quality system
title_full_unstemmed Introduction to the EQIPD quality system
title_short Introduction to the EQIPD quality system
title_sort introduction to the eqipd quality system
topic Neuroscience
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184207/
https://www.ncbi.nlm.nih.gov/pubmed/34028353
http://dx.doi.org/10.7554/eLife.63294
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