摘要
目的 提高临床研究各环节工作质量,保护人体受试者.方法 介绍医院人体研究保护体系的运行操作和管理经验.结果 建立人体研究保护体系可以促进临床研究相关部门直接的沟通与协作,加强对临床研究各环节的管理.结论 医疗机构建立全方位的人体研究规范体系与制度,对促进医院临床研究的高质量发展具有积极的推进作用.
Objective Improve the quality of clinical research at different stages for better protection of human subject.Methods Introduce the operational and the administrative experiences of establishing the human research protection program in our hospital.Results Establish human research protection program can promote the direct communication and cooperation among relevant departments of clinical research,strengthen the whole process management of clinical research.Conclusions Developing comprehensive human research protection program and related policies play a positive role in promoting the high-quality development of clinical research in hospitals.
作者
白彩珍
徐贝贝
任佩娟
肖淑萍
Bai Caizhen;Xu Beibei;Ren Peijuan;Xiao Shuping(Hospital Office,Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing 100070,China;Scientific Research Department,Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing 100070,China)
出处
《中华医学科研管理杂志》
2021年第1期69-72,共4页
Chinese Journal of Medical Science Research Management
关键词
人体研究保护体系
临床研究
体系内定期评估
Human Research Protection Program(HRPP)
Clinical trial
Regular evaluation within the system