基于电子化数据采集和管理的临床研究质量控制的探讨

Discussion on Quality Control of Clinical Research Based on Electronic Data Capture and Management

目的探讨基于电子化数据采集和管理的临床研究质量控制。方法分析影响临床研究质量的研究过程中的不确定因素,然后针对临床研究中的不确定因素、安全风险,探讨通过电子化的数据采集和管理进行质量控制的方法,如逻辑核查、源数据核查、数据汇总统计分析、关键变量的质量检查与评估等。结果电子化数据采集和管理系统的应用对于临床研究的质量具有极大地促进作用。但是,在应用中存在数据录入滞后导致的质量控制手段无法及时实施、价格昂贵等问题。结论有必要建立临床研究质量监控和反馈机制,利用采集的数据及其相关信息实现对临床研究及时有效的监督和管理。

Objective To investigate a method for the quality control of clinical research based on electronic data capture and data management（EDC/CDM）. Methods Firstly, uncertain factors which affected the research quality during the clinical research was analyzed. Secondly, some quality control methods including edit checks, source data verification（SDV）, aggregate statistics, data inspection and comparison are discussed, aiming at the elimination of uncertain factors and safety hazard in clinical research. Results The application of EDC/CDMS can greatly promote clinical research quality. However there are still some problems, i.e., lagging data entry and the high cost of EDC/ CDM, which prevent quality control measures from being conducted timely. Conclusion It is necessary to establish the quality monitoring system and feedback mechanism for clinical research. Captured data and relevant information can be used to supervise and manage the clinical research timely and effectively.