【摘要】 借助于数字技术的远程数据采集方法无论在传统集中式临床研究，还是现代分散式临床研究中，对试验药物的临床效益评估发挥着巨大的作用。作为电子源数据的组成部分，新型数字技术应用于临床数据流管理的合规性操作亦是临床研究中面临的挑战。从《药品临床试验管理规范》(GCP)标准和全球药政监管要求的发展趋势分析，应用于临床研究中的数字技术应当满足电子临床系统的验证标准，相关数据流管理需要符合全球临床研究数据的“ALCOA”原则，申办方、研究者和受试者在其中的资质标准与角色职责也不尽相同。本文针对数字技术如何在临床研究中规范应用，从项目管理角度对数据流的合规性管理和利益相关者的职责要求进行探讨，使得依据数字技术的临床数据在临床研究结果申报中得到药政监管认可成为可能。更多还原

【Abstract】 Direct data capture(DDC) by means of digital health technology(DHT) has been played a significant role in the evaluation of clinical benefits in either traditional centralized clinical trials or novel decentralized clinical trials of medicinal products. As a part of e-source data, a trial execution with the regulatory compliance of the DHT is one of the challenges in clinical data flow managements. In the views of developmental trends in GCP and global regulatory and supervisory requirements, DHT applications in clinical trials should meet the validation standards of an e-clinical system, conforming to the ALCOA principle regarding the trial data flow managements with roles and qualifications of relevant stakeholders, such as sponsors, investigators and subjects. In the standpoints of project management views, this paper discusses how the DHT application is complied with regulations, rational monitoring and supervisions on the DHT data flow, and responsibilities of relevant stakeholders, ensuring the approvability of clinical outcomes on DHT-based clinical data by regulatory authorities.更多还原