我院药物临床试验机构资格认定申报工作的实践与体会

发布时间：2018-05-09 05:10

本文选题：药物临床试验机构 + 资格认定申报　；参考：《中国药房》2015年22期

【摘要】：目的:介绍我院药物临床试验机构资格认定申报工作的经验,为同行提供借鉴参考。方法:从机构建设、药物临床试验伦理委员会构建、上市后药物临床试验工作、模拟资格认定等方面总结我院药物临床试验资格认定申报经验及申报准备重点。结果与结论:应重视人员(特别是机构负责人)及软硬件(制度建设、人员培训、机构办公室和专业科室)的配备,注重伦理委员会的构建,各科室间开展上市后药物临床试验工作经验的分享及成立自查小组进行模拟资格认定;明确资格认定的工作程序及方法,充分熟悉资格认定评判标准《药物临床试验质量管理规范》的要求,认真执行安全的药物临床质量管理规范并保护受试者权益,有助于资格认定申报工作的顺利完成。
[Abstract]:Objective: to introduce the experience of qualification application of drug clinical trial institutions in our hospital, and to provide reference for counterparts. Methods: from the aspects of institution construction, ethics committee of drug clinical trial, clinical trial work after listing and simulated qualification recognition, the experience and the key points of application preparation for qualification determination of drug clinical trial in our hospital were summarized. Results & conclusion: attention should be paid to the equipment of personnel (especially those in charge of institutions) and hardware and software (system building, personnel training, institutional offices and professional departments), and to the construction of ethics committees. To share the working experience of post-marketing clinical trials of drugs among departments and to establish self-examination teams to identify the qualifications; to clarify the working procedures and methods of qualification determination; Fully familiar with the requirements of qualification evaluation standard, quality management standard of drug clinical trials, conscientiously carrying out the safe drug clinical quality management standard and protecting the rights and interests of the subjects is helpful to the successful completion of qualification identification and application.
【作者单位】：中山市人民医院;
【分类号】：R95

【参考文献】