Abstract: Objective To explore how to construct the biobank for Chinese cerebrovascular disease (CVD) multi-center clinical research and the biobank management model, to improve the quality of CVD biological samples and promote resource sharing. Methods Based on the standardization idea of international standardization organizations, referring to the experience of multi-center clinical trial projects, combined with the actual needs of CVD special-disease cohort study, Chinese multi-center CVD clinical research biobank was constructed, and the biobank management model was developed. The management process of multi-center clinical research biobank was developed from the perspectives of sites, facilities and equipment, operation procedure, quality control, etc. Results According to the construction standards proposed in this article, Tiantan Cerebrovascular Disease Biobank has been established, and the management system of biological samples platform for multi-center CVD clinical research was built. Conclusions Tiantan Cerebrovascular Disease Biobank realized centers unified, standardized, realtime, the whole process quality management for multi-center clinical research, which can guarantee the quality of biological samples in multiple centers, and provide high quality biological sample

resources for precise medicine research, such as CVD screening, early warning, diagnosis and

intervention, etc.

Key words: Biobank; Stroke; Multi-center; Clinical research; Quality control

摘要： 目的 开发适合我国的脑血管病多中心临床研究生物样本库的建设及管理模式，为提高脑血管病 专病队列研究生物样本质量、促进资源共享提供技术保障。 方法 基于国际标准化组织等机构的标准化思路，参考多中心临床试验项目经验，结合脑血管病专 病队列研究实际需求，形成我国脑血管病多中心临床研究生物样本库建设及管理模式。从场地、设 施设备、操作规程、质量控制等多个维度，建立多中心临床研究生物样本管理流程。 结果 依据本研究提出的建设要求，开发了天坛脑血管病多中心临床研究生物样本管理系统，建立 了多中心临床研究生物样本质量管理体系。 结论 天坛脑血管病多中心临床研究生物样本库实现了各中心统一、标准、实时、全流程的质量管 理，可以保障多中心临床研究项目的生物样本质量水平，为脑血管病筛查、预警、诊断与干预等精准医 学研究提供高质量生物样本资源。

关键词: 生物样本库; 卒中; 多中心; 临床研究; 质量管理