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临床研究数据管理对结果的准确可靠性有决定性作用,是保证中医临床试验质量的关键性工作。数据管理员、课题负责人以及参与的研究者,均应高度加强临床研究数据规范管理的理念。设计阶段即应明确原始文件和原始数据范围,以便有效管理,保证数据的可溯源性。数据管理要有总体设计,数据管理方案要系统,分工清楚,责任明确。电子数据管理是临床研究数据管理核心环节,也是提高数据管理质量的关键,便利于质量监管,方便进行数据溯源。过程还需制订研究病历或病例报告表,并充分测试;选定数据管理软件,建立电子数据库;电子数据录入多采用双人双录方式,且要遵守时间窗要求上报;源数据现场核查;数据清理与疑问管理;在第1次揭盲之前,对数据库盲态审核;闭合数据库。
The clinical research data management is decisive for the accuracy and reliability of the results and is the key work to ensure the quality of TCM clinical trials. Data administrators, project leaders and participating researchers should all strongly promote the concept of standardized management of clinical research data. At the design stage, the scope of the original document and the original data should be clear so that it can be effectively managed and the traceability of the data can be ensured. Data management to have the overall design, data management programs to the system, a clear division of labor, a clear responsibility. Electronic data management is the core of clinical research data management, but also the key to improve the quality of data management, facilitating quality supervision and facilitating data traceability. The process also need to develop a study case or case report form, and fully tested; selected data management software, the establishment of electronic databases; electronic data entry using double double recording method, and to comply with the requirements of the time window; source data on-site verification; data cleaning And question management; Blind review of the database before the first unblinding; close the database.