1临床试验的监查惠氏制药有限公司临床研究开发部刘玉成医学督导 2 临床试验监查的目的–保证临床试验中受试者的权益受到保障–保证试验记录与报告的数据准确、完整无误–保证试验遵循已批准的方案和有关法规进行 ICH GCP 3 监查员( Monitor )的角色和作用监查员是申办者与研究者之间的主要联系人 ICH GCP 4 合格的 Monitor 应具备的条件–应有适当的医学、药学或相关专业学历–经过必要的培训–应熟悉药品管理有关法规–应熟悉有关试验药物的临床前和临床方面的信息–应熟悉临床试验方案及其相关的文件 5 临床试验监查的种类–研究中心启动的拜访 ( Site Initiation Visit) –研究进行中的拜访 ( Site Monitoring Visit) –受试者访视完成后的拜访 ( Site Closeout Visit) 6 Monitoring Visit Intervals The above monitoring visit intervals are given as an example. Actual monitoring visit internals shall be defined in the monitoring plan. SDV: source data verification will be performed after site personnel has transcribed data into CRF After resolution of all data queries sent to the site Closeout Visit Within 2 weeks after the site ’ s last subject visit Last Monitoring Visit Every 2 weeks, including one dosing day and one ic sampling day. Between First and Last Subject Visit As soon as practical, but no later than 2 weeks after the first patient visit. 1 st Monitoring Visit Within 1-2 weeks prior to first patient visit. Site Initiation Visit mended Target Monitoring Period 7 Pre-study visit Pre-study Post- study Close out visit Monitoring Plan 2. Monitoring Reports 1. Query Log Study Monitoring Process Outline Live Phase Study Period Screening Study Entry First dosing & PK Multiple PK Check ICD, I/E Check dosing & PK Perform source data verification Follow Up visit 8 临床试验监查的步骤安排–监查拜访前的准备–监查拜访中的职责–监查拜访后的跟踪 9 临床试验监查的步骤安排–监查拜访前的准备 10 临床试验监查的步骤安排–总结前次监查拜访发现的问题是否已经解决–准备本次监查拜访所需文件–与研究中心确定拜访日期和时间,告知本次拜访的主要目的,确定可以见到及需要见到的人员–安排行程应有富余的时间,以便解决突发的问题
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