Nourani Aynaz, Ayatollahi Haleh, Dodaran Masoud Solaymani
Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran, Iran.
Rev Recent Clin Trials. 2019;14(3):160-172. doi: 10.2174/1574887114666190207151500.
Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.
Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.
Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.
It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.
数据管理是临床试验中一个重要、复杂且多维度的过程。若不使用信息技术，执行此过程将非常困难且成本高昂。临床数据管理系统是一种广泛用于管理临床试验中产生的数据的软件。本研究的目的是回顾临床试验数据管理系统的技术特征。
通过检索数据库（如科学网、Scopus、科学Direct、ProQuest、Ovid和PubMed）来识别相关文章。纳入研究的所有与临床数据管理系统相关的研究论文均发表于2007年至2017年之间（n = 19）。
大多数临床数据管理系统是基于网络的系统，在尽可能短的时间内根据特定临床试验的需求开发。系统开发中使用了SQL Server和MySQL数据库。这些系统并未充分支持临床数据管理过程。此外，大多数系统在系统开发方面缺乏灵活性和可扩展性。
研究中心使用的大多数系统似乎在支持数据管理过程和管理临床试验工作流程方面较为薄弱。因此，应更加关注为临床试验设计一个更完整、可用且高质量的数据管理系统。建议开展更多研究以确定临床试验中成功使用的系统的特征。
