基于HACCP构建临床研究项目全流程管理指标体系  

The clinical research process management indicator system based on the theory of Hazard Analysis and Critical Control Point

作　　者：苗苗[1] 于玲玲[1] 王欣[1] 赵海娟[1] 王情情 刘飞 张鹏俊[1] Miao Miao;Yu Lingling;Wang Xin;Zhao Haijuan;Wang Qingqing;Liu Fei;Zhang Pengjun(Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院国家老年医学中心中国医学科学院老年医学研究院,北京100730

出　　处：《中华医学科研管理杂志》2022年第5期338-343,共6页Chinese Journal of Medical Science Research Management

基　　金：北京医院院级课题(BJ-2019-173);北京医院"科技新星"项目(BJ-2020-088);中央高校基本科研业务费专项资金资助(3332021080)。

摘　　要：目的基于危害分析与关键控制点原理(Hazard Analysis and Critical Control Point, HACCP), 构建研究者发起的临床研究项目全流程管理指标体系。方法根据HACCP原则制订计划, 邀请23名专家组成专家咨询小组, 采用文献研究、专题小组讨论、德尔菲法采集临床研究项目过程管理指标, 并运用层次分析法AHP计算各项指标权重。结果两轮咨询专家积极系数和专家权威程度高, 最终形成了3个一级指标, 14个二级指标。一级指标分别为"项目立项"、"项目过程管理"和"项目结题考核", 权重分别为0.142 8、0.714 4和0.142 8。结论本研究基于HACCP理论从项目立项、项目过程管理、项目结题考核3个维度建立管理指标体系, 依据二级指标权重开展临床研究精准管理, 重视权重大的指标管理内容, 为研究者发起的临床研究管理提供重要参考依据。Objective To build an investigator-initiated clinical research process management indicator system based on the theory of Hazard Analysis and Critical Control Point(HACCP).Methods A plan was developed according to HACCP principles,and 23 experts were invited to form an expert advisory group.Literature research,panel discussion,and Delphi method were used to collect clinical research process management indicators,and the weight of each indicator was calculated via Analytic Hierarchy Process(AHP).Results Two rounds of expert consultation were carried out with a high positive coefficient and a high expert authority level,and finally formed 3 primary indicators and 14 secondary indicators.The primary indicators were project establishment,project process management,and project implementation assessment,with weights of 0.1428,0.7144,and 0.1428,respectively.Conclusions This study established a clinical research process management system based on HACCP theory from 3 dimensions:project establishment,project process management,and project implementation assessment,carried out precise management of clinical research according to the weights of secondary indicators,focusing on the content of indicators with great weight,and provided an important reference for the management of investigator-initiated clinical research.

关 键 词：HACCP危害分析与关键控制点 临床研究过程管理 指标体系 

分 类 号：R-3[医药卫生]