Introduction to the EQIPD quality system.

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_FE5311322B31
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Introduction to the EQIPD quality system.
Journal
eLife
Author(s)
Bespalov A., Bernard R., Gilis A., Gerlach B., Guillén J., Castagné V., Lefevre I.A., Ducrey F., Monk L., Bongiovanni S., Altevogt B., Arroyo-Araujo M., Bikovski L., de Bruin N., Castaños-Vélez E., Dityatev A., Emmerich C.H., Fares R., Ferland-Beckham C., Froger-Colléaux C., Gailus-Durner V., Hölter S.M., Hofmann M.C., Kabitzke P., Kas M.J., Kurreck C., Moser P., Pietraszek M., Popik P., Potschka H., Prado Montes de Oca E., Restivo L., Riedel G., Ritskes-Hoitinga M., Samardzic J., Schunn M., Stöger C., Voikar V., Vollert J., Wever K.E., Wuyts K., MacLeod M.R., Dirnagl U., Steckler T.
ISSN
2050-084X (Electronic)
ISSN-L
2050-084X
Publication state
Published
Issued date
24/05/2021
Peer-reviewed
Oui
Volume
10
Pages
e63294
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
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.
Keywords
neuroscience, drug discovery, nonregulated research, research rigor
Pubmed
Web of science
Open Access
Yes
Create date
31/05/2021 8:44
Last modification date
23/11/2022 8:17
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