【作者】 高超；

【导师】 王美琴；

【作者基本信息】 山东大学 ， 信息安全， 2015， 硕士

【摘要】 目前,在新药临床研究中,临床临床试验(RCT)是公认的试验研究的金标准。但在具体试验操作过程中,尚存在数据共享过程中敏感信息如盲底易失密,随机分配方案易被人为干预,通过简单的替代姓名等标识属性发布的数据容易被攻击破解,样本众多病历难于录入查阅等诸多问题。因此,如何对数据资料进行集中加密保管,避免使用中泄密,同时又能有效抵御攻击是目前新药临床研究中亟待解决的问题。有文献指出,盲底信息保存存在缺陷,容易泄密是导致试验整体质量不高的重要原因。本文的主要创新点在于完成了由计算机代替人工进行盲底编制工作,实现了自动化的隐蔽分组；利用数论中的算术基本定理对盲底信息进行加密的同时优化了数据结构；采用了Shamir秘密共享算法,将传统的盲底保管方式改为多人共享保管,解决了盲底保管过程中容易失密的问题。盲底信息的隐藏对提高随机对照临床试验的研究质量具有重大意义。该系统在上述理论研究的基础上,还需要提供各种功能以满足试验数据管理的需要。例如,拟采用BS架构方便在多中心进行部署,集成CRF表方便研究者采集受试者信息,提供多种试验流程供申办者选择,编写随机分组程序使得受试者分组过程避免人为干预。本系统的易用性和对数据的在线分析功能仍待加强,这是下一步工作的重点。更多还原

【Abstract】 At present, in the new drug clinical research, randomized clinical trial (RCT) is recognized as gold standard. But in the specific operation of test process, there are still some problems in the process of data sharing sensitive information such as the blind codes easily to be compromised, random allocation scheme easily to be released through human intervention, and so on. Therefore, how to encrypt data on storage, not only avoid the use of leakage, but also can effectively resist the attack of clinical research on new drugs are urgent problems which are still need to solve.Some literatures pointed out that the defect of storage in blind codes is the important reason of the low quality in RCTs.The main innovation of this paper is to completed the blind codes preparation work by the computer instead of manual, to achieve the automation of concealment; using the fundamental theorem of number theory in the blind codes encryption and optimizing the data structure; using the Shamir secret sharing algorithm in blind codes of the custody to sharing message between many people. The hide of blind codes plays an important role to improve the quality of randomized clinical trials.The system is based on the research of the theory, but also need to provide a variety of functions in order to content the need of test data management. For example, the BS framework to facilitate the deployment in the multi centers, integrated CRF table is convenient for researchers to collect information about the subjects, provide a variety of test procedures for the sponsor, write program to avoid the artificial intervention.The easy way to use this system and the data online analysis is still need to be strengthened, which is the focus of next steps.更多还原