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INFRAFRONTIER quality principles in systemic phenotyping.

ABSTRACT: Improving reproducibility and replicability in preclinical research is a widely discussed and pertinent topic, especially regarding ethical responsibility in animal research. INFRAFRONTIER, the European Research Infrastructure for the generation, phenotyping, archiving, and distribution of model mammalian genomes, is addressing this issue by developing internal quality principles for its different service areas, that provides a quality framework for its operational activities. This article introduces the INFRAFRONTIER Quality Principles in Systemic Phenotyping of genetically altered mouse models. A total of 11 key principles are included, ranging from general requirements for compliance with guidelines on animal testing, to the need for well-trained personnel and more specific standards such as the exchange of reference lines. Recently established requirements such as the provision of FAIR (Findable, Accessible, Interoperable, Reusable) data are also addressed. For each quality principle, we have outlined the specific context, requirements, further recommendations, and key references.

SUBMITTER: Ehlich H

PROVIDER: S-EPMC8913563 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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INFRAFRONTIER quality principles in systemic phenotyping.

Ehlich Hilke H Cater Heather L HL Flenniken Ann M AM Goncalves Da Cruz Isabelle I Mura Anne-Marie AM Ntafis Vasileios V Raess Michael M Selloum Mohammed M Stoeger Claudia C Suchanova Sarka S Vuolteenaho Reetta R Brown Steve D M SDM Hérault Yann Y Hinttala Reetta R Hrabě de Angelis Martin M Kollias George G Kontoyiannis Dimitris L DL Malissen Bernard B McKerlie Colin C Sedláček Radislav R Wells Sara E SE Zarubica Ana A Rozman Jan J Sorg Tania T

Mammalian genome : official journal of the International Mammalian Genome Society 20210730 1

Improving reproducibility and replicability in preclinical research is a widely discussed and pertinent topic, especially regarding ethical responsibility in animal research. INFRAFRONTIER, the European Research Infrastructure for the generation, phenotyping, archiving, and distribution of model mammalian genomes, is addressing this issue by developing internal quality principles for its different service areas, that provides a quality framework for its operational activities. This article intro ...[more]

PMID: 34328547

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Project description:BackgroundDemonstrating that the data produced in metabolic phenotyping investigations (metabolomics/metabonomics) is of good quality is increasingly seen as a key factor in gaining acceptance for the results of such studies. The use of established quality control (QC) protocols, including appropriate QC samples, is an important and evolving aspect of this process. However, inadequate or incorrect reporting of the QA/QC procedures followed in the study may lead to misinterpretation or overemphasis of the findings and prevent future metanalysis of the body of work.ObjectiveThe aim of this guidance is to provide researchers with a framework that encourages them to describe quality assessment and quality control procedures and outcomes in mass spectrometry and nuclear magnetic resonance spectroscopy-based methods in untargeted metabolomics, with a focus on reporting on QC samples in sufficient detail for them to be understood, trusted and replicated. There is no intent to be proscriptive with regard to analytical best practices; rather, guidance for reporting QA/QC procedures is suggested. A template that can be completed as studies progress to ensure that relevant data is collected, and further documents, are provided as on-line resources.Key reporting practicesMultiple topics should be considered when reporting QA/QC protocols and outcomes for metabolic phenotyping data. Coverage should include the role(s), sources, types, preparation and uses of the QC materials and samples generally employed in the generation of metabolomic data. Details such as sample matrices and sample preparation, the use of test mixtures and system suitability tests, blanks and technique-specific factors are considered and methods for reporting are discussed, including the importance of reporting the acceptance criteria for the QCs. To this end, the reporting of the QC samples and results are considered at two levels of detail: "minimal" and "best reporting practice" levels.

Project description:INTRODUCTION:'Systems thinking' is often recommended in healthcare to support quality and safety activities but a shared understanding of this concept and purposeful guidance on its application are limited. Healthcare systems have been described as complex where human adaptation to localised circumstances is often necessary to achieve success. Principles for managing and improving system safety developed by the European Organisation for the Safety of Air Navigation (EUROCONTROL; a European intergovernmental air navigation organisation) incorporate a 'Safety-II systems approach' to promote understanding of how safety may be achieved in complex work systems. We aimed to adapt and contextualise the core principles of this systems approach and demonstrate the application in a healthcare setting. METHODS:The original EUROCONTROL principles were adapted using consensus-building methods with front-line staff and national safety leaders. RESULTS:Six interrelated principles for healthcare were agreed. The foundation concept acknowledges that 'most healthcare problems and solutions belong to the system'. Principle 1 outlines the need to seek multiple perspectives to understand system safety. Principle 2 prompts us to consider the influence of prevailing work conditions-demand, capacity, resources and constraints. Principle 3 stresses the importance of analysing interactions and work flow within the system. Principle 4 encourages us to attempt to understand why professional decisions made sense at the time and principle 5 prompts us to explore everyday work including the adjustments made to achieve success in changing system conditions.A case study is used to demonstrate the application in an analysis of a system and in the subsequent improvement intervention design. CONCLUSIONS:Application of the adapted principles underpins, and is characteristic of, a holistic systems approach and may aid care team and organisational system understanding and improvement.

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INFRAFRONTIER quality principles in systemic phenotyping.

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INFRAFRONTIER quality principles in systemic phenotyping.

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