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Certification for biobanks: The program developed by the canadian tumour repository network (CTRNet) (Conference Paper)

机译:生物库认证:由加拿大肿瘤库网络(CTRNet)开发的程序(会议论文)

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摘要

Two core aspects of the discipline of biobanking are biospecimen quality and good governance. Meeting the demands of both sample quality and governance can be challenging, especially in a resource limited environment. Frequently, differences between biobank processes reduce the ability for cooperative action and specimen sharing with researchers. In the Canadian context, we have made an attempt to identify these gaps and have provided a framework to support excellence, initially for tumor biobanks. The Canadian Tumour Repository Network (CTRNet) was established with funding from the Canadian Institute of Health Sciences (CIHR) Institute of Cancer Research (ICR) to foster translational research through improved access to high quality tumour biospecimens. Consistent with this mandate, CTRNet has focused on the establishment and deployment of common standards to harmonize biospecimen quality and approaches to governance. More recently, CTRNet has implemented a certification program to communicate these standards in conjunction with simultaneous exposure to education focusing on the rationale and foundations underlying these standards. The CTRNet certification program comprises registration and certification steps as two linked phases. In the registration phase, launched in November 2011, biobanks are registered into the system and individuals complete an introductory educational module. In the subsequent certification phase, the type of biobank is classified and assigned relevant educational modules and adoption of relevant standards of practice is confirmed through review of documentation including policies and protocols that address the CTRNet Required Operational Practices (ROPs). An important feature of the program is that it is intended for all types of tumor biobanks, so the scope and extent of assessment is scaled to the type of biobank. This program will provide an easily adoptable and flexible mechanism to communicate common standards through education and address both quality assurance and governance across the broad spectrum of biobanks.
机译:生物银行学科的两个核心方面是生物样本质量和良好治理。满足样品质量和管理要求都可能是一个挑战,特别是在资源有限的环境中。通常,生物库过程之间的差异会降低协作作用和与研究人员共享标本的能力。在加拿大,我们已经尝试找出这些差距,并提供了一个框架来支持卓越,最初是针对肿瘤生物库。加拿大肿瘤知识库网络(CTRNet)由加拿大健康科学研究所(CIHR)癌症研究所(ICR)资助建立,旨在通过改善对高质量肿瘤生物标本的获取来促进转化研究。根据这一授权,CTRNet致力于建立和部署通用标准以协调生物样本质量和治理方法。最近,CTRNet实施了一项认证计划,以传达这些标准,并同时接受针对这些标准的依据和基础的教育。 CTRNet认证计划包括注册和认证步骤两个链接阶段。在2011年11月启动的注册阶段,生物银行已注册到系统中,个人完成了入门教育模块。在随后的认证阶段,将对生物库的类型进行分类并分配相关的教育模块,并通过审查文档(包括解决CTRNet所需操作规范(ROP)的政策和协议)来确认采用相关的实践标准。该计划的一个重要特征是它适用于所有类型的肿瘤生物库,因此评估的范围和程度将根据生物库的类型而定。该计划将提供一种易于采用和灵活的机制,以通过教育交流通用标准,并解决广泛范围的生物库中的质量保证和治理问题。

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