专业化分工体系在临床研究中的效果评价

摘要

Objective To establish a specialized division of labor system for cerebrovascular disease clinical research and verify the effectiveness of specialized division of labor system in the management of cerebrovascular disease clinical research.Methods Using Delphi method to establish the specialized division of labor system of clinical research,identify personnel responsibilities,access mechanism and access standards.Compare two clinical studies that using and not using this system in terms of clinical research management efficiency,effectiveness of the clinical research progress and quality control.Results Specialized division of labor system can reduce the time spent for research design and preparation,improve the research progress and data integrity,reduce the protocol deviation and the loss of subject follow up.Conclusions Specialized division of labor system can improve the efficiency of clinical research management and improve the research progress and quality.%目的 建立一套临床研究专业化分工体系,验证该专业化分工体系在临床研究管理中的效果.方法 采用Delphi法制定临床研究专业化人员的职责、准2机制及标准等一系列临床研究专业化分工体系.对比在两个研究中分别采用与未采用该体系对临床研究管理效率、研究进度与质量控制的效果.结果 采用临床研究专业化分工体系可缩减研究设计及准备时间;提高研究进度与计划进度符合率及数据完整性;降低研究方案违背率及受试者随访失访率.结论 提示采用专业化分工模式可提高临床研究管理效率,提高研究进度与质量.