民营医院药物临床试验机构建设

药物临床试验机构的申请设立对于医疗机构科研和医疗质量的提高均具有深远的意义，民营医院也应积极加入到申请设立的行列中。但是民营医院申请药物临床试验机构资格认定的案例比较少，缺乏可借鉴的经验。本文从当地政府和医院的政策支持、机构办公室建设、伦理委员会建设、质控体系建立、人才建设、各专业科室的内部建设、材料的准备、现场检查时的注意事项等8个方面对苏州九龙医院药物临床试验机构申请工作做了详细的介绍。

Experience on construction of drug clinical trials institution

The drug clinical trials are benefit in increasing the level of scientific research and medical quality for hospital. But private hospitals are lack of experiences in application of drug clinical trials institution. In the paper, we made ？？a detailed introduction about the construction of drug clinical trial institution in our hospital.It is noted that the support of local government and hospital, building of institution office, construction of the Ethics Committee, establishment of quality control system, development of human resource, construction of clinical professional departments, preparation of material, notices on-site inspection.