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加拿大组织储存库网络生物样本库认证计划:2011年至2018年该计划的更新与回顾

Canadian Tissue Repository Network Biobank Certification Program: Update and Review of the Program from 2011 to 2018.

作者信息

Hartman Victoria, Gali Brent, Dee Simon, O'Donoghue Sheila, Tarling Tamsin, Barnes Rebecca, de Ladurantaye Manon, Mes-Masson Anne-Marie, Watson Peter H

机构信息

Biobanking and Biospecimen Research Services, Deeley Research Centre, British Columbia Cancer-Victoria Center, Victoria, Canada.

Office of Biobank Education and Research, Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.

出版信息

Biopreserv Biobank. 2019 Dec;17(6):530-538. doi: 10.1089/bio.2019.0015. Epub 2019 Jun 13.

Abstract

The Canadian Tissue Repository Network (CTRNet) Biobank Certification Program was first launched in 2011 to foster translational research through improved access to high quality biospecimens. This was accomplished by creating and providing biobank education and through the establishment and deployment of common standards to harmonize biospecimen quality and approaches to governance. The CTRNet program comprises registration and certification steps as two linked phases. In the two-step registration phase, the biobank is registered into the system, and an individual completes an overview educational module. In the subsequent certification phase, biobanks undergo a seven-step process, including inviting team members, assigning and completing relevant education modules, uploading documents, and undergoing a documentation audit. As of June 2018, there were 251 biobanks engaged in the CTRNet program, 193 had completed registration, and 40 were fully certified. Over 3/4 of these biobanks completed registration within a week and over 1/3 completed certification within a month. Among registered biobanks, 163 were associated with North American institutions, while 30 were from other international locations, including Australia, Europe, and Asia. The CTRNet program enables biobanks to adopt standards with a flexible approach to accommodate different types of biobanks and a measured investment of effort, creating the foundation for increased access to high quality biospecimens.

摘要

加拿大组织库网络(CTRNet)生物样本库认证计划于2011年首次启动,旨在通过改善高质量生物样本的获取途径来促进转化研究。这是通过开展生物样本库教育以及建立和实施统一生物样本质量与管理方法的通用标准来实现的。CTRNet计划包括注册和认证步骤这两个相互关联的阶段。在两步注册阶段,生物样本库被录入系统,个人完成一个概述性教育模块。在随后的认证阶段,生物样本库要经历七个步骤,包括邀请团队成员、分配并完成相关教育模块、上传文件以及接受文件审核。截至2018年6月,有251个生物样本库参与了CTRNet计划,193个已完成注册,40个获得了完全认证。这些生物样本库中超过3/4在一周内完成了注册,超过1/3在一个月内完成了认证。在已注册的生物样本库中,163个与北美机构有关联,30个来自其他国际地点,包括澳大利亚、欧洲和亚洲。CTRNet计划使生物样本库能够以灵活的方式采用标准,以适应不同类型的生物样本库并适度投入精力,为增加高质量生物样本的获取奠定了基础。

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