Introduction to the EQIPD Quality System

• DOI: 10.31219/osf.io/ng32b
• Publication Date: 2020-07-28T14:30:07Z
• Authors: Anton Bespalov; Rene Bernard; Björn Gerlach; Christoph Emmerich; Malgorzata Pietra...; Isabel Ann Lefevre; Esmeralda Castaño...; Alexander Dityatev; Patricia Kabitzke; Claudia Kurreck; Gernot Riedel; Jan Vollert; Kimberley Wever; Ulrich Dirnagl; Malcolm Macleod
• Keywords: 0301 basic medicine; 03 medical and health sciences; Pharmacology, Toxicology and Environmental Health; Laboratory and Basic Science Research Life Sciences; Medicine and Health Sciences; Research Methods in Life Sciences; Life Sciences; 3. Good health

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. Numerous analyses conducted to date have clearly identified measures that need to be taken to improve research rigor. 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. Further, EQIPD is preparing training support and assessment services for those research units that successfully implement the quality system and would like to 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.