ichgcp中英文对照(完整).pdfVIP

ICH 三方协调指导原则 E6 ICH GCP 指导原则 INTRODUCTION 前 言 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 临床试验管理规范（GCP ）是设计、实施、记录和报告设计人类对象参加的试验