摘要
临床试验是新药研究开发的必经阶段，对评价新药的疗效和安全性起着无可替代的作用。确保临床试验符合国家规范、试验数据真实、试验结论可靠，是药品监管及研发部门共同关心的问题。本文结合本院新药l临床试验前、试验中、试验后三个阶段中机构的管理进行阐述，探讨药物临床试验机构的规范化管理对确保高质量完成新药临床试验的重要作用。
Clinical trial is an indespensable phase of new drug resem＇ch and development. It plays an irreplaceable role in evaluation of new drug＇s efficacy and safety.How to carry it in line with repulation and ensure the aeeuraey of the trial data,the reliablity of the conclusion are the common concern of the drug regulatory and R ＆ D department. We described the management of the Clinical trial institution in our hospital in three phases： pre-,during and post- trial to discuss the importance of the standardized management in elinial trials proceeding.
关键词
临床试验
规范管理
质量保证
Clinical Trials Standard Management Quality
