临床科研服务平台源数据管理及应用研究

Study on Source Data Management and Application of Clinical Research Service Platform

目的为了安全、实时地对临床科研服务平台的仪器设备源数据进行存储和备份,保障临床研究数据完整性、真实性和准确性。方法根据品管圈管理模式,组建源数据管理小组,及时收集问题并进行反馈,讨论科学可行的解决方法并付诸行动。结果通过品管圈模式,在发生问题的第一时间及时改进数据存储和备份的方法,使仪器设备的源数据得以更安全、有效的方式进行存储,实现了临床研究数据的完整、准确,并且可溯源。结论品管圈管理模式在管理临床科研服务平台的源数据方面切实可行。

Objective To store and back up the source data from the instruments of the clinical research service platform safely and timely,and to ensure the integrity,authenticity and accuracy of clinical research data.Methods Source data management team was set up based on quality control circle model to collect problems and feed back in time and to discuss about and carry out scientific and feasible solutions.Results Through the quality control circle model,the methods of data storage and backup was improved soon after problems occurred,so that the source data from the instruments could be stored in a safer and more effective way,and that the clinical research data could be complete,accurate and traceable.Conclusion The quality control circle model is feasible in managing the source data of clinical research service platform.