[关键词]
[摘要]
主要论述《临床试验用药品信息系统管理专家共识》的起草背景、适用范围,以及试验用药品信息化管理系统的架构、配置、管理要求。从临床试验用药品管理的实际出发,对临床试验用药品的流转进行全程化、标准化、精准化和实时化的管理。促使临床试验用药品信息化管理能够实现试验用药品从申办者运输,研究中心接收、验收、入库、存储、出库、领用发放、用药、回收、返还、退回、销毁、留样(如适用)等全流程在线实时记录管理,提高药品管理规范性,保证数据的及时性、准确性、可靠性和可溯源性。
[Key word]
[Abstract]
The consensus was mainly discussed the drafting background and the range of application of "Expert consensus on information system management of investigational product(s)", it also stipulates the framework, configuration and management requirements of the management system. Considering the actual management of Investigational Products, the products circulation process was managed in a full, standardized, precise and real-time manner. Promoting the information management of Investigational Products could realize the online real-time record management in the whole process, such as transporting, receiving, checking, warehousing, storage, delivery, distribution, administration, recovery, restore, return, destruction, retention (if applicable). The Consensus is committed to improving the standardization of Investigational Products management and ensuring the timeliness, accuracy, reliability and traceability of data.
[中图分类号]
R954
[基金项目]
重大新药创制科技重大专项(2020ZX09201007);国家重点研发计划公共安全风险防控与应急技术装备重点项目(2020YFC0844400)