医院药物临床试验中实施GCP的细化管理

Micro-management of GCP Implementation in Drug Clinical Trials

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。

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.