摘要
药物临床试验档案资料是药物临床试验全过程的真实记录和体现,药品监督管理部门主要据此进行新药审批,相关档案资料应该准确、完整、可靠。分析了药物临床试验档案资料管理在研究者、监查员和药物临床试验基地3个层面存在的一些问题,就药物临床试验档案资料规范化管理探讨了相关解决办法和注意事项,提出研究者及时规范完成记录、监查员认真细致核查、专业档案管理人员时时跟进归整是药物临床试验档案资料完整的重要保证。
Archives of drug clinical trial reflect the whole processes of drug clinical trials,which are the major evi-dences of approval of new drugs for drug regulatory authorities.Accordingly,the related data files should be accu-rate,complete,and reliable.This paper analyzed the problems in the management of archives about drugs clinical trials from three dimensions including researchers,inspectors and sites for drug clinical trial.After that,we ex-plored the solutions and considerations for the standardized management of archives about drugs clinical trials.We suggest that researches should finish the record timely and detailed,inspectors should check the archives carefully, and professional management staff should follow up and sort out the archives constantly.
出处
《中国社会医学杂志》
2014年第2期84-85,共2页
Chinese Journal of Social Medicine
基金
国家科技人员服务企业行动计划(2009gjd10050)
