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Introduction to the EQIPD quality system.

ABSTRACT: 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.

SUBMITTER: Bespalov A

PROVIDER: S-EPMC8184207 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Introduction to the EQIPD quality system.

Bespalov Anton A Bernard René R Gilis Anja A Gerlach Björn B Guillén Javier J Castagné Vincent V Lefevre Isabel A IA Ducrey Fiona F Monk Lee L Bongiovanni Sandrine S Altevogt Bruce B Arroyo-Araujo María M Bikovski Lior L de Bruin Natasja N Castaños-Vélez Esmeralda E Dityatev Alexander A Emmerich Christoph H CH Fares Raafat R Ferland-Beckham Chantelle C Froger-Colléaux Christelle C Gailus-Durner Valerie V Hölter Sabine M SM Hofmann Martine Cj MC Kabitzke Patricia P Kas Martien Jh MJ Kurreck Claudia C Moser Paul P Pietraszek Malgorzata M Popik Piotr P Potschka Heidrun H Prado Montes de Oca Ernesto E Restivo Leonardo L Riedel Gernot G Ritskes-Hoitinga Merel M Samardzic Janko J Schunn Michael M Stöger Claudia C Voikar Vootele V Vollert Jan J Wever Kimberley E KE Wuyts Kathleen K MacLeod Malcolm R MR Dirnagl Ulrich U Steckler Thomas T

eLife 20210524

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 r ...[more]

PMID: 34028353

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Introduction to the EQIPD quality system.

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Introduction to the EQIPD quality system.

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