适应真实世界研究的生物样本及数据资源库建设

Construction of Biobank based on the real world study

目的探讨适应真实世界研究的临床生物样本及数据资源库的建设方法。方法通过规范化伦理管理、质量控制、数据自动化管理和随访管理等工作,收集2014年11月至今的生物样本,不断完善生物样本数据库资源,以适应真实世界研究的实施。结果在确保患者隐私和信息安全的基础上,基于精良的仪器设备和数据自动化管理模式,以统一的SOP执行标准,髙质量采集生物样本及临床数据信息,逐步完善生物样本及数据信息管理体系,实现样本数据资源的整合与共享。结论人类样本及数据资源库是转化医学研究的关键,我院样本库在收集生物样本的同时,通过链接临床数据信息,推动相关数据在真实世界研究中的应用。

Objective To explore the strategies of constructing clinical biobank based on the real world study.Methods Biospecimens have been collected since November 2014,as well as continuingly construction of the biobank resources to match the implenmentation of real world study.Related measurements adopted including standardized ethical management,quality control,automated data management,and follow-up management.Results Biospecimens and clinical data information were collected with high quality according to standard SOPs.Sophisticated equipment and data automation management mode were used to make sure the protection of patient privacy and data security.At the same time,biospecimens and data information management system were improved gradually to fulfill the integration and sharing of biospecimen data resources.Conclusions Biorepositories are the key to translational medical research,biospecimens collected in our biobank will link with clinical data information simultaneously,which increase the resource pool that can be applied in real world study.