我国药物临床试验的科学监管.pptVIP

* 资格认定的意义 Significance of qualification accreditation for clinical trial institution 对申办者 扩大临床试验机构的选择范围 减小选择研究者的盲目性 增加选择研究者的主动性 改善临床试验开展的条件 减少对研究者的培训投入 获得高质量的临床试验数据 缩短临床试验的周期 降低临床试验的风险和投入 For sponsors Lower blindness on selecting investigators Improve conditions for clinical trials Decrease the input for investigator training Shorten clinical investigation period Get high quality data and credible results Minimize risk and financial input * 资格认定的意义 Significance of qualification accreditation for clinical trial institution For Investigators/institutions More doctors and more chance to perform clinical evaluation of safety and efficacy of new drugs Rise the research level and increase their chance to participate international co-operation Promote rational medicine use and higher quality of clinical practice Help to perform ADR monitoring and PMS Promote the development of evidence based Medicine Enhance the management level of hospital 对研究者 参与新药安全性、有效性评价 提升科研水平，开展国际合作 促进合理用药，提高医疗质量 开展ADR监测和药物警戒学研究 开展医疗器械临床试验 提升医院的管理水平 促进循证医学的发展 Procedures for qualification accreditation Re-inspection Re-correction within limited time Qualified Re-correction needed Unqualified Qualification Certificate Regular Inspection Disqualification Unqualified Announcement Application Primary review Filing Site inspection Doc. review * 资格认定的基本要求 Requirements for Qualification Accreditation for clinical trial institution Be medical institution (hospital) With management organization Qualified staff and suitable training of GCP, and clinical trial knowledge Sufficient conditions, facilities and instruments Enough Subject sources Formulation of and compliance with SOPs Retaining, archiving of documentation 医疗机构（医院） 组织管理机构 合格的人员并经GCP、临床试验技术培训 足够的试验和急救设施和仪器设备 充足的受试者来源 制订并遵循SOP 试验资料的保管设施和制度 试验药物的保管实施和制度 * 资格认定的进展情况(至06年9月底) 机构数量 专业情况 原基地专业 新申请 总数 申 请 327 586 2292 2872 已 检 查 261 491 1912 2403 公告通过 158 - - 1035 限期整改 8 - - - 待 检 查 47 95 377 472 * 药物临床试验机构的监督管理 定期报告：获得资格