医院药物临床试验中实施GCP的细化管理

J4 ›› 2015, Vol. 14 ›› Issue (4): 21-25.

医院药物临床试验中实施GCP的细化管理

1.大理学院附属医院，云南大理671000；2.大理学院昆明附属医院，昆明650011

收稿日期:2014-07-29 出版日期:2015-04-15 发布日期:2015-04-15
作者简介:谷祥富，主管药师，主要从事临床药学研究.

Micro-management of GCP Implementation in Drug Clinical Trials

1. Affiliated Hospital of Dali University, Dali, Yunnan 671000, China; 2.Affiliated Hospital of Dali University in Kunming, Kunming
650011, China

Received:2014-07-29 Online:2015-04-15 Published:2015-04-15

摘要/Abstract

摘要：

目的：医院药物临床试验中实施GCP的细化管理。方法：查阅药物临床试验中实施GCP的相关文献，并进行分析、归
纳总结。结果：GCP涉及的一些原则尚需进一步具体和细化。结论：细化管理药物临床试验的GCP，使药物临床试验的质量管
理具有更强的可操作性、科学性、可靠性。

关键词: GCP, 临床试验, 质量管理

Abstract:

Objective: To discuss the micro-management of GCP implementation in drug clinical trials. Methods: Literature of GCP
in clinical trials were reviewed, analyzed and concluded. Results: Some principles of GCP need specific and detailed study.
Conclusion: Micro-management of GCP implementation is more operational, scientific and reliable for drug clinical trials.

Key words: GCP, clinical trial, quality management

中图分类号:

谷祥富，朱晓丽，王学昌. 医院药物临床试验中实施GCP的细化管理[J]. J4, 2015, 14(4): 21-25.

Gu Xiangfu, Zhu Xiaoli, Wang Xuechang. Micro-management of GCP Implementation in Drug Clinical Trials[J]. J4, 2015, 14(4): 21-25.