世界GCP的发展历史 第一个时期:20世纪初至60年代,是药物从基本无管理状态到药物临床试验管理体系逐步形成的时期 “磺胺酏剂事件”--致使35...
药物临床试验质量管理规范,Good Clinical Practice(GCP)是药物临床试验全过程的质量标准,包括方案设计、组织实施、监查、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...