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论文编号：	14532
作者编号：	2320213775
上传时间：	2024/6/1 12:00:37
中文题目：	去中心化在临床试验监查中的应用研究以肿瘤项目为例
英文题目：	Research on the Application of Decentralization in Clinical Trial Monitoring: A Case Study of Oncology Project
指导老师：	侯文华
中文关键字：	临床试验；去中心化；技术支持；数据管理
英文关键字：	Clinical Trails; Decentralized; Technical Support; Data Management
中文摘要：	随着科技的飞速发展和医疗信息化的普及，临床试验的开展和进行面临着更加复杂的挑战和更高的数据共享需求。然而，传统的临床试验开展模式依然受地域、条件或不可抗力等因素的影响和限制，存在安全和数据隐患，从而导致不可预料的后果。近年来，去中心化技术受到了广泛的关注，它具有高度的安全性，可以不受地域限制，通过去中心化监查的方式可以审查原始资料、核查相关数据。且在数据安全性方面也做了很大提升，可以防止篡改，进行加密，并且可以进行溯源，这些都是它的优势。鉴于当前的医学环境，为了更好地实现临床试验的去中心化，以及确保临床科研人员能够更加便捷地获取大量数据，本文借助相关的理论及技术基础，对比国内外去中心化的开展情况，通过介绍去中心化在临床试验监查的问题、解决方案，并结合案例分析实施的可能性，研究去中心化在临床试验监查的具体应用。 本文将深入讨论去中心化临床试验的实施和应用。首先从临床试验数据的重要性、现有的医联体云平台的技术分析和去中心化的问题总等角度来分析实现去中心化临床试验监查需要解决的问题。然后，本文结合存在的问题，进一步去探讨去中心化在临床试验监查的实施和应用。介绍去中心化的必要性，具体实施的原则、步骤，相关系统的建立，需要具备的保障措施，以及从管理角度论证如何确保去中心化在临床试验监查的应用。最后本文通过案例分析，结合现有的医疗条件，提出对未来实施去中心化的总结和展望。 本文旨在探讨如何结合当下法规条件，通过利用去中心化技术来真正解决去中心化在临床试验监查的问题。希望可以为其他领域的去中心化提供宝贵的经验，而且还可以为未来的发展和应用提供重要的借鉴。
英文摘要：	With the rapid development of science and technology and the popularization of medical informatization, the development and development of clinical trials are facing more complex challenges and higher data sharing needs. However, the traditional clinical trial mode is still affected and limited by geographical, conditions or force majeure factors, which has hidden safety and data risks, leading to unpredictable consequences. In recent years, decentralized technology has attracted wide attention. It has a high degree of security and can not be subject by geographical restrictions. Raw data can be reviewed and checked through decentralized monitoring. And in the data security has also been made a great improvement, can prevent tampering, encryption, and can be traced back, these are its advantages. In view of the current medical environment, in order to better realize the decentralization of clinical trials, and ensure that clinical researchers can more convenient access to a large amount of data, this paper with the relevant theoretical and technical basis, comparing the decentralization at home and abroad, by introducing the development of decentralization in the clinical trial monitoring problems, solutions, and combined with the possibility of case analysis, study the specific application of decentralization in clinical trial monitoring. This thesis discusses in depth the implementation and application of decentralized clinical trials. Firstly, the problems to be solved to realize the implementation of decentralized clinical trial monitoring are analyzed from the perspective of the importance of clinical trial data, the technical analysis of the existing medical consortium cloud platform and the general problems of decentralization. Then, this paper combines the existing problems to further explore the implementation and application of decentralization in clinical trial monitoring. It introduces the necessity of decentralization, the principles and steps of specific implementation, the establishment of relevant systems, the safeguard measures needed, and how to ensure the application of decentralization in clinical trial monitoring from the perspective of management. Finally, through the case analysis and combined with the existing medical conditions, this paper proposes the summary and prospect of the future implementation of decentralization. This thesis aims to explore how to truly solve the problem of decentralization in clinical trial monitoring by combining the current regulatory conditions. Hope can provide valuable experience for decentralization in other fields, and can also provide important lessons for future development and application.
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