临床试验的监查-刘玉成.ppt

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 Monitoring Period Site Initiation Visit 1 st Monitoring Visit Between First and Last Subject Visit Last Monitoring Visit Closeout Visit mended Target Within 1-2 weeks prior to first patient visit. As soon as practical, but no later than 2 weeks after the first patient visit. Every 2 weeks, including one dosing day and one ic sampling day. Within 2 weeks after the site ’ s last subject visit After resolution of all data queries sent to the site 7 Pre-study visit Pre-study Post- study Clo se 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 Che ck ICD, I/E Che ck dosi ng & PK Perform source data verification Foll ow 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