Ⅰ期临床试验病房的管理及体会

Management and experience of phaseⅠclinical trial ward

Ⅰ期临床试验病房是进行新药Ⅰ期临床试验的场所,必须严格执行药物临床试验质量管理规范(GCP)的规定。Ⅰ期临床试验是新药人体试验的起始阶段、是初步的临床药理学和人体安全性评价试验。天津中医药大学第二附属医院自2004年7月开设Ⅰ期临床试验病房,在工作中不断完善Ⅰ期临床试验病房管理,更新标准操作规程(SOP),保证Ⅰ期临床试验规范、严谨、安全开展。概述该院Ⅰ期病房的管理情况及工作体会。

PhaseⅠclinical trial ward was the place where phaseⅠclinical trials of new drugs were conducted.The procedures in trials must be strictly implemented by Good Clinical Practice(GCP).PhaseⅠclinical trials are the initial stage of new drugs in human,mainly for preliminary clinical pharmacology and the evaluation of human safety.PhaseⅠclinical trial ward has been established in The Second Affiliated Hospital of Tian Jin University of Traditional Chinese Medicine since 2004,and the management was gradually improving in the work.We updates standard operating procedures(SOP) to ensure phaseⅠclinical trials be conducted standardized,rigorous,and safe.This article will outline the management and work experience of phaseⅠclinical trial ward in our hospital to readers,and promote common progress.