METHODS:The role of hospital pharmacists in publicizing and training of Good Clinical Practice(GCP),in the formulation of each standard operating instruction and in each stage of clinical drug trial was analyzed.
方法:分析医院药师在《药物临床试验质量管理规范》的宣传、培训,各项标准操作规程的制订过程中及临床试验各期所发挥的作用。
METHODS: The advantages of both the guiding principle of Good Clinical Practice(GCP) and the quality standards of ISO/IEC17025:2005 were applied throughout the quality control process of clinical drug trial.
方法:将《药物临床试验质量管理规范》(GCP)的指导原则和《检测和校准实验室能力的通用要求》(ISO/IEC17025)质量管理标准优势互补,贯穿于药物临床试验质控的全过程。
