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Comparison and Analysis of Two Internationally Recognized Biobanking Standards.
Biopreservation and Biobanking ( IF 1.6 ) Pub Date : 2020-04-09 , DOI: 10.1089/bio.2019.0126
Tamsin Tarling 1 , Sheila O'Donoghue 2, 3 , Rebecca Barnes 3 , Karlene Carvalho 2 , Brent Gali 2, 3 , Marta Castelhano 4 , Anne-Marie Mes-Masson 3, 5 , Peter H Watson 1, 2, 3
Affiliation  

Impactful biobanking is underpinned by quality assurance and standardization. Several general biobank standards exist that can be associated with programs to provide different levels of conformity assessment, including the Canadian Tissue Repository Network (CTRNet) Certification program and the International Organization for Standardization (ISO) 20387 and accreditation bodies. We examined the CTRNet Required Operational Practices (2017) and ISO 20387 (2018), to compare them. Although the organization of each standard is different, both describe a set of discrete requirements (elements or subclauses) that comprise the standards that are contained in sections called chapters (CTRNet) or clauses (ISO). The standards have a similar number of requirements (CTRNet: 362, ISO: 322). To compare these standards, we reclassified the requirements in the ISO standard into 13 categories based on a combination of the chapter headings used in the ISBER and NCI Best Practices that represent important areas of biobanking activity. This categorization of requirements showed that each standard has a different emphasis reflected in different densities of requirements within distinct areas of biobanking. The ISO standard emphasizes Quality Management Systems whereas the CTRNet standard has an even coverage across the full spectrum of biobanking areas, including activities that are relevant to participant enrollment. Nevertheless, ∼60% of the requirements in the CTRNet standard match with those of the ISO standard. We conclude that these two standards have much in common but recommend that individual biobanks consider each standard carefully in the context of the purpose, focus, scale, and scope of their biobank to determine the appropriate standard to be followed.

中文翻译:

两种国际公认的生物银行标准的比较和分析。

有效的生物银行以质量保证和标准化为基础。现有几种通用的生物库标准,可以与提供不同级别合格评定的程序相关联,包括加拿大组织库网络(CTRNet)认证程序以及国际标准化组织(ISO)20387和认可机构。我们比较了CTRNet要求的操作规范(2017)和ISO 20387(2018),以进行比较。尽管每个标准的组织都不相同,但是两者都描述了一组离散的要求(要素或子条款),这些要求构成了包含在称为章节(CTRNet)或条款(ISO)的部分中的标准。这些标准具有相似数量的要求(CTRNet:362,ISO:322)。为了比较这些标准,我们根据ISBER和NCI最佳实践中代表生物银行活动重要领域的章节标题的组合,将ISO标准中的要求分为13类。需求的分类表明,每个标准在生物银行不同领域内的需求密度不同,体现出不同的重点。ISO标准强调质量管理体系,而CTRNet标准涵盖了整个生物库领域的均匀覆盖,包括与参与者注册相关的活动。但是,CTRNet标准中约60%的要求与ISO标准相匹配。
更新日期:2020-04-09
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