Introduction to the eqipd quality system

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

doi:10.7554/eLife.63294

Introduction to the eqipd quality system

Anton Bespalov, René Bernard, Anja Gilis, Björn Gerlach, Javier Guillén, Vincent Castagné, Isabel A. Lefevre, Fiona Ducrey, Lee Monk, Sandrine Bongiovanni, Bruce Altevogt, María Arroyo-Araujo, Lior Bikovski, Natasja de Bruin, Esmeralda Castaños-Vélez, Alexander Dityatev, Christoph H. Emmerich, Raafat Fares, Chantelle Ferland-Beckham, Christelle Froger-ColléauxValerie Gailus-Durner, Sabine M. Hölter, Martine C.J. Hofmann, Patricia Kabitzke, Martien J.H. Kas, Claudia Kurreck, Paul Moser, Malgorzata Pietraszek, Piotr Popik, Heidrun Potschka, Ernesto Prado Montes de Oca, Leonardo Restivo, Gernot Riedel, Merel Ritskes-Hoitinga, Janko Samardzic, Michael Schunn, Claudia Stöger, Vootele Voikar, Jan Vollert, Kimberley E. Wever, Kathleen Wuyts, Malcolm R. Macleod, Ulrich Dirnagl, Thomas Steckler

Human Molecular Genetics Biochemistry

Tel Aviv University

Research output: Contribution to journal › Editorial

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.

Original language	English
Article number	e63294
Journal	eLife
Volume	10
DOIs	https://doi.org/10.7554/eLife.63294
State	Published - May 2021

All Science Journal Classification (ASJC) codes

General Neuroscience
General Biochemistry,Genetics and Molecular Biology
General Immunology and Microbiology

Access to Document

10.7554/eLife.63294

Cite this

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., ... Steckler, T. (2021). Introduction to the eqipd quality system. eLife, 10, Article e63294. https://doi.org/10.7554/eLife.63294

@article{664aa9dae77947a0af33a06f1160cb56,

title = "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{\textquoteright}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.",

author = "Anton Bespalov and Ren{\'e} Bernard and Anja Gilis and Bj{\"o}rn Gerlach and Javier Guill{\'e}n and Vincent Castagn{\'e} and Lefevre, {Isabel A.} and Fiona Ducrey and Lee Monk and Sandrine Bongiovanni and Bruce Altevogt and Mar{\'i}a Arroyo-Araujo and Lior Bikovski and {de Bruin}, Natasja and Esmeralda Casta{\~n}os-V{\'e}lez and Alexander Dityatev and Emmerich, {Christoph H.} and Raafat Fares and Chantelle Ferland-Beckham and Christelle Froger-Coll{\'e}aux and Valerie Gailus-Durner and H{\"o}lter, {Sabine M.} and Hofmann, {Martine C.J.} and Patricia Kabitzke and Kas, {Martien J.H.} and Claudia Kurreck and Paul Moser and Malgorzata Pietraszek and Piotr Popik and Heidrun Potschka and {de Oca}, {Ernesto Prado Montes} and Leonardo Restivo and Gernot Riedel and Merel Ritskes-Hoitinga and Janko Samardzic and Michael Schunn and Claudia St{\"o}ger and Vootele Voikar and Jan Vollert and Wever, {Kimberley E.} and Kathleen Wuyts and Macleod, {Malcolm R.} and Ulrich Dirnagl and Thomas Steckler",

note = "Publisher Copyright: {\textcopyright} Bespalov et al.",

year = "2021",

month = may,

doi = "10.7554/eLife.63294",

language = "الإنجليزيّة",

volume = "10",

journal = "eLife",

issn = "2050-084X",

publisher = "eLife Sciences Publications",

}

Bespalov, A, Bernard, R, Gilis, A, Gerlach, B, Guillén, J, Castagné, V, Lefevre, IA, Ducrey, F, Monk, L, Bongiovanni, S, Altevogt, B, Arroyo-Araujo, M, Bikovski, L, de Bruin, N, Castaños-Vélez, E, Dityatev, A, Emmerich, CH, Fares, R, Ferland-Beckham, C, Froger-Colléaux, C, Gailus-Durner, V, Hölter, SM, Hofmann, MCJ, Kabitzke, P, Kas, MJH, Kurreck, C, Moser, P, Pietraszek, M, Popik, P, Potschka, H, de Oca, EPM, Restivo, L, Riedel, G, Ritskes-Hoitinga, M, Samardzic, J, Schunn, M, Stöger, C, Voikar, V, Vollert, J, Wever, KE, Wuyts, K, Macleod, MR, Dirnagl, U & Steckler, T 2021, 'Introduction to the eqipd quality system', eLife, vol. 10, e63294. https://doi.org/10.7554/eLife.63294

TY - JOUR

T1 - Introduction to the eqipd quality system

AU - Bespalov, Anton

AU - Bernard, René

AU - Gilis, Anja

AU - Gerlach, Björn

AU - Guillén, Javier

AU - Castagné, Vincent

AU - Lefevre, Isabel A.

AU - Ducrey, Fiona

AU - Monk, Lee

AU - Bongiovanni, Sandrine

AU - Altevogt, Bruce

AU - Arroyo-Araujo, María

AU - Bikovski, Lior

AU - de Bruin, Natasja

AU - Castaños-Vélez, Esmeralda

AU - Dityatev, Alexander

AU - Emmerich, Christoph H.

AU - Fares, Raafat

AU - Ferland-Beckham, Chantelle

AU - Froger-Colléaux, Christelle

AU - Gailus-Durner, Valerie

AU - Hölter, Sabine M.

AU - Hofmann, Martine C.J.

AU - Kabitzke, Patricia

AU - Kas, Martien J.H.

AU - Kurreck, Claudia

AU - Moser, Paul

AU - Pietraszek, Malgorzata

AU - Popik, Piotr

AU - Potschka, Heidrun

AU - de Oca, Ernesto Prado Montes

AU - Restivo, Leonardo

AU - Riedel, Gernot

AU - Ritskes-Hoitinga, Merel

AU - Samardzic, Janko

AU - Schunn, Michael

AU - Stöger, Claudia

AU - Voikar, Vootele

AU - Vollert, Jan

AU - Wever, Kimberley E.

AU - Wuyts, Kathleen

AU - Macleod, Malcolm R.

AU - Dirnagl, Ulrich

AU - Steckler, Thomas

PY - 2021/5

Y1 - 2021/5

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85108021350&partnerID=8YFLogxK

U2 - 10.7554/eLife.63294

DO - 10.7554/eLife.63294

M3 - كلمة العدد

C2 - 34028353

SN - 2050-084X

VL - 10

JO - eLife

JF - eLife

M1 - e63294

ER -

Introduction to the eqipd quality system

Abstract

All Science Journal Classification (ASJC) codes

Access to Document

Other files and links

Fingerprint

Cite this