CAJ | 학술논문

在国家食品药品监督管理总局对药物临床机构资格审查中发现，伦理委员会运行存在如下问题：伦理委员会管理制度及SOP不完善；对工作制度和审查程序不熟悉；跟踪审查不规范；试验项目资料管理混乱；伦理委员会硬件不达标。对这些问题进行分析并针对这些问题提出以下解决措施：合理调整组织结构，加强制度建设，规范审查程序，建立人员三级培训模式和改善办公条件。
재국가식품약품감독관리총국대약물림상궤구자격심사중발현，윤리위원회운행존재여하문제：윤리위원회관리제도급SOP불완선；대공작제도화심사정서불숙실；근종심사불규범；시험항목자료관리혼란；윤리위원회경건불체표。대저사문제진행분석병침대저사문제제출이하해결조시：합리조정조직결구，가강제도건설，규범심사정서，건립인원삼급배훈모식화개선판공조건。
The authors through the analysis on the state food and drug administration for clinical drug agency qualification , the ethics committee to run the problem:ethics committee incomplete management system and SOP;Familiar with work system and review process to be;Track review is not standard;Pilot project information manage-ment confusion;Ethics committee hardware substandard housing .And puts forward the following measures to solve these problems , reasonable adjustment of organization structure , strengthen the system construction , standard re-view process , establish 3 levels training model and improve office conditions .