药物临床试验新专业备案自评标准制定及备案实施管理  

Self-assessment Standards for New Majors in Drug Clinical Trials and the Record Management Practices

作　　者：刘泽干 唐莉[1] 马俊龙 蔡蒋帆 李海平[1] 张澈[1] LIU Ze-gan;TANG Li;MA Jun-long;CAI Jiang-fan;LI Hai-ping;ZHANG Che(Affiliated Taihe Hospital of Hubei University of Medicine,Hubei Shiyan 442000,China)

机构地区：[1]湖北医药学院附属十堰市太和医院,湖北十堰442000

出　　处：《中国药物评价》2020年第5期394-399,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:建立机构内部药物临床试验新专业备案自评标准,探讨新形势下药物临床试验新专业备案工作有效实施的方法。方法:依照相关法规和管理规定要求,结合我院10余年管理经验和多次资质复核及新专业申报检查经验,制定以研究团队、专业条件和设施设备、管理制度与标准操作规程、质量与风险管理等自评标准,通过成立机构内部自评小组对申请备案新专业进行现场评定,并以现场评定报告作为是否准许备案的依据。结果:制定了完整新专业备案自评标准;通过自评小组的现场评定,19个申请备案专业中15个专业通过备案自评,其中9个专业具备资格,6个专业基本具备资格,2个专业改进再评,2个专业不具备资格。结论:新专业备案自评标准具有较高的执行性,备案管理具有一定参考意义。Objective:To establish self-assessment standards for recording the new majors in drug clinical trials and explore effective implementation methods in the new situation.Methods:In accordance with relevant laws and management requirements,Meanwhile,combined with our more than 10 years of management experience,multiple qualification reviews and new professional inspection experience.Our self-assessment standards were established based on the research team,professional conditions and implementation equipments,management systems and standard operating procedures,quality and risk managements,etc.The internal self-assessment team was established to conduct the on-site assessment for new majors.And the on-site assessment report was the crucial basis for whether or not is permitted for recording.Results:The complete self-assessment standards for new majors were established.Via the on-site assessment of the self-assessment team,15 of the 19 majors applying for records passed the self-assessment.The number of majors that were basically qualified was six,the number of majors that were improved and re-evaluated was two,and the number of majors that were not qualified was two.Conclusion:The self-assessment standard for recording new majors is highly enforceable,and the record managements own certain reference significance.

关 键 词：药物临床试验 备案 新专业 标准 药物临床试验质量管理规范(GCP) 

分 类 号：R95[医药卫生—药学]