体外诊断试剂临床试验样本全流程管理专家共识  

Consensus on the whole-process management of in vitro diagnostic reagent clinical trial samples

作　　者：湖北省药物与医疗器械临床评价学会 中国药理学会药物临床试验专业委员会 黄建英[2] 赵秀丽[3] 吴建元[2] 刘珏[4] Hubei Drug and Medical Device Clinical Evaluation Society;Drug Clinical Trial Committee of Chinese Pharmacological Society;Huang Jianying;Zhao Xiuli

机构地区：[1]不详 [2]武汉大学中南医院临床试验中心 [3]首都医科大学附属北京同仁医院国家药物临床试验机构 [4]武汉市中心医院国家药物临床试验机构

出　　处：《中华检验医学杂志》2022年第10期1039-1044,共6页Chinese Journal of Laboratory Medicine

基　　金：湖北省重点研发计划(2020BCB016);湖北省卫生健康委员会卫生健康科研立项(WJ2021M169);武汉大学中南医院2021年度医学科技创新平台支撑项目(临床研发项目lcyf202107)。

摘　　要：国家药品监督管理局(NMPA)制定了一系列体外诊断试剂(IVD)临床试验相关政策及指导原则,对IVD临床试验的科学性与规范性提出了更高的要求,有助于推动我国IVD产业的规范发展,提升临床试验能力。为进一步规范IVD临床试验样本管理,针对试验用样本来源、编号、保存、使用、留存、销毁等全流程关键环节,结合相关指导原则和最新政策要求,综合领域专家建议和意见,共同制定本共识,旨在为IVD临床试验研究人员提供参考和指导,为IVD临床试验用样本全流程管理提供操作规范。In recent years, the National Medical Products Administration (NMPA) has formulated a series of relevant policies and guidelines for clinical trials of in vitro diagnostic reagents(IVD), which have put forward higher requirements for the scientificity and standardization of clinical trials of in vitro diagnostic reagents, which will help to promote standardized development of the IVD industry and enhance capabilities of conducting clinical trial. In order to further standardize the sample management of IVD clinical trial, the source, serial number, preservation, use, retention, destruction and other key links of the whole process of the samples used for testing, this consensus is jointly formulated in combination with the relevant guiding principles and the latest policy requirements, and the suggestions and opinions of experts in this field. This consensus is aimed to provide reference, guidance, and standard operational norms for the whole-process management of samples for IVD clinical trials.

关 键 词：体外诊断试剂 临床试验 样本 全流程管理 

分 类 号：R95[医药卫生—药学]