摘要
临床试验中,安全性信息的监管是核心部分,直接关系着受试者安全和临床试验的质量,也为上市后药品说明书中安全性事项说明提供可靠依据。新版《药物临床试验质量管理规范》和相关法规及指导原则对临床试验中安全性信息收集提出了更高的要求,但临床质量控制中存在安全性信息概念不清、来源收集不全和名称记录不准确等问题。为进一步规范安全性信息的收集,应加强临床试验参与人员培训、提高风险意识,广泛收集和记录安全性信息并优化设计,建立追踪监管体系,以期保护受试者安全。
In clinical trials,the supervision of safety information is the core part,which is directly related to the safety of subjects and the quality of clinical trials,and also provides a reliable basis for the description of safety matters in the drug specifications after marketing.The new GCP and related regulations and guidelines have set higher requirements for the collection of safety information in clinical trials.But there are many problems in the clinical quality control,including unclear concept of security information,incomplete source collection,inaccurate name record,etc.In order to further standardize the collection of safety information,the training of clinical trial participants should be strengthened,risk awareness should be enhanced,safety information should be widely collected and recorded and the design should be optimized,and a tracking and supervision system should be established to protect the safety of the subjects.
作者
曹丽亚
郭薇
谢林利
陈勇川
CAO Li-ya;GUO Wei;XIE Lin-li;CHEN Yong-chuan(Department of Pharmacy,the First Affiliated Hospital of Army Medical University,CHONGQING 400038,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2020年第8期468-471,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
重庆市科学技术委员会资助项目(cstc2018jsyj-zdcxX0079)。
关键词
临床试验
质量控制
安全性
不良事件
clinical trial
quality control
security
adverse events
作者简介
曹丽亚,女,主管药师,硕士,主要从事药学、药物临床试验机构管理的研究,Phn:86-15215059940,E-mail:caoliya008@163.com。
