【摘要】 通过一项疫苗临床试验国际合作项目的实施,讨论了如何在科学研究中贯彻落实GCP。结果表明,ICH提出的13项GCP指导原则在疫苗临床试验中得到了充分的实施。GCP不仅是临床试验的管理和指导原则,同时也保护研究对象的权利、保证资料的可信和自觉遵守标准操作程序(SOP)的意识。更多还原

【Abstract】 The aim of this paper is to illustrate practical examples derived from an international vaccine trial,regarding the implementation of GCP guidelines.The result showed that the 13 GCP principles proposed by the ICH were fully applicable to vaccine trials.GCPs are not just about regulation and guideline;GCPs protect the rights of subjects involved in trials and ensure reliable data and SOP consciousness.更多还原