基于电子数据获取的临床研究数据管理计划的制定及其关键因素探讨

Discussion on developing a data management plan and its key factors in clinical study based on electronic data capture system

数据管理是临床研究质量控制的关键环节,数据管理计划(data management plan,DMP)对于每一项临床研究都是不可或缺的,它为数据管理工作提供全面的指导,使各部门工作遵循良好的临床研究数据管理规范,同时DMP也是稽查人员对数据管理部门必须稽查的文件之一。因此,撰写一份符合本机构实际情况的,高质量的DMP十分重要。本文从制定DMP的意义、临床研究数据管理规范对于制定DMP的最低标准和最佳措施、基于电子数据获取(electronic data capture,EDC)的临床研究DMP的制定、制定DMP的关键因素等几个方面进行探讨。最后针对在中医临床研究中使用EDC系统存在的问题进行分析,并提出改进的建议。

Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice （GCDMP）. Meanwhile, the data management plan （DMP） is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture （F_DC） and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors： designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.