Towards norms for accreditation of biobanks for human health and medical research: compilation of existing guidelines into an ISO certification/accreditation norm‐compatible format
F. Betsou, A. Luzergues, A. Carter, Peter Geary, P. Riegman, B. Clark, M. Morente, J. Vaught, R. Dhirr, C. Druez-Vérité
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引用次数: 41
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Abstract
In recent years, biobanks have evolved into professional infrastructures that acquire, validate, process, store, manage and distribute biological material of human origin to public or private end-users/researchers. This article (a) highlights the importance of quality assurance for both the biobank basic processes and sample annotation in order to ensure reliable results of research based on these samples, (b) suggests that certification according to international standards can contribute to the organization of the biobanking processes while accreditation can contribute to the organization of sample characterization/validation, and (c) provides a compilation of all existing guidelines against an International Organization for Standardization (ISO) format. Copyright © 2008 John Wiley & Sons, Ltd.
制定用于人类健康和医学研究的生物库认证规范:将现有准则汇编成与ISO认证/认可规范兼容的格式
近年来,生物银行已经发展成为专业的基础设施,用于获取、验证、处理、存储、管理和向公共或私人最终用户/研究人员分发人类来源的生物材料。本文(a)强调了生物库基本流程和样本标注质量保证的重要性,以确保基于这些样本的可靠研究结果,(b)建议根据国际标准进行认证可以有助于生物库流程的组织,而认可可以有助于样品表征/验证的组织。(c)提供针对国际标准化组织(ISO)格式的所有现有准则的汇编。版权所有©2008 John Wiley & Sons, Ltd
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