Construction and validation of a Biological Sample Quality Management System for Multicenter Clinical Research of Cerebrovascular Diseases

doi:10.3969/j.issn.1673-5765.2025.12.014

Chinese Journal of Stroke ›› 2025, Vol. 20 ›› Issue (12): 1576-1582.DOI: 10.3969/j.issn.1673-5765.2025.12.014

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Construction and validation of a Biological Sample Quality Management System for Multicenter Clinical Research of Cerebrovascular Diseases

LIN Jinxi^1,2,3, LI Shangzhi^1,2, WANG Mengxing^1,2, MENG Xia^1,2,3

1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
2 China National Clinical Research Center for Neurological Diseases, Beijing 100070, China
3 Center of Stroke, Beijing Institute of Brain Disorders, Beijing 100070, China

Received:2025-09-04 Revised:2025-12-01 Accepted:2025-12-05 Online:2025-12-20 Published:2025-12-20
Contact: LIN Jinxi, E-mail: linjx@ncrcnd.org.cn

脑血管病多中心临床研究生物样本质量管理体系的构建与验证研究

林金嬉^1，2，3，李上智^1，2，王梦星^1，2，孟霞^1，2，3

1 北京 100070 首都医科大学附属北京天坛医院神经病学中心
2 国家神经系统疾病临床医学研究中心
3 北京脑重大疾病研究院脑卒中研究所

通讯作者: 林金嬉 linjx@ncrcnd.org.cn
基金资助:
国家重点研发计划（2017YFC1310900；2016YFC0901002；2016YFC0901000）

Abstract

Abstract: Objective To explore the role of the quality management system in enhancing the standardized management of biological samples in multicenter clinical research on cerebrovascular diseases, thereby providing evidence for promoting the quality improvement of biological samples in multicenter clinical research.
Methods Based on the actual needs of specialized cohort studies on cerebrovascular diseases and referring to the experience of previous multicenter clinical trial projects, this paper explores the biological sample management process suitable for multicenter clinical research on cerebrovascular diseases in China from multiple dimensions such as pre-preparation, protocol design, operation norms, and quality management.
Results A full-process quality management system for biological samples in multicenter clinical research on cerebrovascular diseases has been established to standardize the quality management of biological samples in multicenter clinical research projects.
Conclusions Implementing a unified and standardized biological sample quality management system in multicenter clinical research can provide high-quality biological sample resources for clinical research on cerebrovascular diseases, facilitating the development of precision medicine research and resource sharing in this field.

Key words: Biobank; Stroke; Multicenter clinical research; Quality management

摘要： 目的探讨质量管理体系对提升脑血管病多中心临床研究生物样本规范化管理水平的作用，为推动多中心临床研究生物样本质量提升提供依据。
方法根据脑血管病专病队列研究的实际需求，参考既往多中心临床研究项目经验，从前期准备、方案设计、操作规范、质量管理等多个维度，探讨适合我国的脑血管病多中心临床研究生物样本管理流程。
结果构建了脑血管病多中心临床研究生物样本全流程质量管理体系，以规范多中心临床研究项目的生物样本质量管理。
结论在多中心临床研究中落实统一、规范的生物样本质量管理体系，可以为脑血管病临床研究提供高质量生物样本资源，并有利于推动脑血管病精准医学研究的发展及资源共享。

关键词: 生物样本库; 卒中; 多中心临床研究; 质量管理

CLC Number:

LIN Jinxi, LI Shangzhi, WANG Mengxing, MENG Xia. Construction and validation of a Biological Sample Quality Management System for Multicenter Clinical Research of Cerebrovascular Diseases[J]. Chinese Journal of Stroke, 2025, 20(12): 1576-1582.

林金嬉, 李上智, 王梦星, 孟霞. 脑血管病多中心临床研究生物样本质量管理体系的构建与验证研究[J]. 中国卒中杂志, 2025, 20(12): 1576-1582.

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Construction and validation of a Biological Sample Quality Management System for Multicenter Clinical Research of Cerebrovascular Diseases

脑血管病多中心临床研究生物样本质量管理体系的构建与验证研究

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