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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
eLife Sciences Publications, Ltd
2021
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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. |
format | Online Article Text |
id | pubmed-8184207 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | eLife Sciences Publications, Ltd |
record_format | MEDLINE/PubMed |
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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