Tarling Tamsin, O'Donoghue Sheila, Barnes Rebecca, Carvalho Karlene, Gali Brent, Castelhano Marta, Mes-Masson Anne-Marie, Watson Peter H
Office of Biobank Education and Research, Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Biobanking and Biospecimen Research Services, Deeley Research Centre, BC Cancer Agency, Victoria, British Columbia, Canada.
Biopreserv Biobank. 2020 Apr;18(2):82-89. doi: 10.1089/bio.2019.0126. Epub 2020 Jan 27.
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.
有影响力的生物样本库建设以质量保证和标准化为基础。存在一些通用的生物样本库标准，这些标准可与提供不同级别合格评定的项目相关联，包括加拿大组织库网络（CTRNet）认证项目、国际标准化组织（ISO）20387标准以及认证机构。我们研究了CTRNet的《必需操作规范》（2017年）和ISO 20387（2018年），以进行比较。尽管每个标准的结构不同，但两者都描述了一组离散的要求（要素或子条款），这些要求构成了在称为章节（CTRNet）或条款（ISO）的部分中包含的标准。这两个标准的要求数量相似（CTRNet：362条，ISO：322条）。为了比较这些标准，我们根据国际生物和环境样本库协会（ISBER）和美国国立癌症研究所（NCI）最佳实践中使用的章节标题组合，将ISO标准中的要求重新分类为13个类别，这些标题代表了生物样本库活动的重要领域。这种对要求的分类表明，每个标准都有不同的侧重点，这反映在生物样本库不同领域内要求的不同密度上。ISO标准强调质量管理体系，而CTRNet标准在生物样本库的全领域具有均匀的覆盖范围，包括与参与者招募相关的活动。尽管如此，CTRNet标准中约60%的要求与ISO标准的要求相匹配。我们得出结论，这两个标准有很多共同之处，但建议各个生物样本库根据其生物样本库的目的、重点、规模和范围，仔细考虑每个标准，以确定应遵循的适当标准。
