世界GCP的發(fā)展歷史 第一個時期:20世紀(jì)初至60年代,是藥物從基本無管理狀態(tài)到藥物臨床試驗管理體系逐步形成的時期 “磺胺酏劑事件”--致使35...
藥物臨床試驗質(zhì)量管理規(guī)范,Good Clinical Practice(GCP)是藥物臨床試驗全過程的質(zhì)量標(biāo)準(zhǔn),包括方案設(shè)計、組織實施、監(jiān)查、稽...
Contents Part 4: Investigational New Drugs Responsibilities Part 5: Summ...
Contents Part 1: Introduction Part 2: Phases of Clinical Trials of Inves...
Contents Part 7: Using Incentives for Study Participation Part 8: What t...
Contents Part 4: Advertising for Study Participants Part 5: Retention Pa...
Contents Part 1: Introduction Part 2: Recruitment Part 3: Recruitment St...
Contents Part 2: Responsibilities by Role -- 2 Part 3: Summary of Key Po...
Contents Part 1: Introduction Part 2: Responsibilities by Role -- 1 Part...