研究者发起的临床研究过程质量管理探讨

Discussion about the process quality management of investigator-initiated clinical trials

目的:目前研究者发起的临床研究质量管理体系尚不完善,通过探讨研究者发起的临床研究开展过程质量管理实施办法,以促进研究质量提升,保护受试者安全。方法:本文总结了研究实施阶段开展过程质量管理的内容、程序和保障因素,探讨了针对研究者发起的临床研究进行过程质量管理的一些做法和经验。结果:研究进行初期及进行中,侧重研究方案修改管理、伦理跟踪审查、授权分工、研究进度与随访、执行的规范性、经费管理等,并关注数据的完整性和可溯源性。开展质量控制的时间可从首例开始,便于尽早发现问题并及时处理。结论:研究者发起的临床研究过程质量管理是保障研究质量的关键,应加大投入,切实落实。

Objective:To investigate the process quality management of investigator-initiated clinical trials(IIT)for which the quality management system is still imperfect in order to promote the research quality and protect the subjects.Methods:The content,procedure and guarantee of process quality assessment since the project start were summarized.The quality control practice of our center was discussed.Results:In the process of study,we should pay attention to the protocol amendment,ethical follow-up review,authorizing and delegating of work,monitoring research progress,follow-up quality,execution normaltivity and research grant.The integrality and traceability of data are also important.Starting the quality management procedure from the first subject is essential for finding the problems and solving them in time.Conclusion:Process quality management of IITs is the key point of quality control since the launch of the research.We should increase the investment and ensure the implementation.