主要論述《臨床試驗(yàn)用藥品信息系統(tǒng)管理專家共識(shí)》的起草背景、適用范圍，以及試驗(yàn)用藥品信息化管理系統(tǒng)的架構(gòu)、配置、管理要求。從臨床試驗(yàn)用藥品管理的實(shí)際出發(fā)，對(duì)臨床試驗(yàn)用藥品的流轉(zhuǎn)進(jìn)行全程化、標(biāo)準(zhǔn)化、精準(zhǔn)化和實(shí)時(shí)化的管理。促使臨床試驗(yàn)用藥品信息化管理能夠?qū)崿F(xiàn)試驗(yàn)用藥品從申辦者運(yùn)輸，研究中心接收、驗(yàn)收、入庫、存儲(chǔ)、出庫、領(lǐng)用發(fā)放、用藥、回收、返還、退回、銷毀、留樣（如適用）等全流程在線實(shí)時(shí)記錄管理，提高藥品管理規(guī)范性，保證數(shù)據(jù)的及時(shí)性、準(zhǔn)確性、可靠性和可溯源性。

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.

R954

重大新藥創(chuàng)制科技重大專項(xiàng)（2020ZX09201007）；國(guó)家重點(diǎn)研發(fā)計(jì)劃公共安全風(fēng)險(xiǎn)防控與應(yīng)急技術(shù)裝備重點(diǎn)項(xiàng)目（2020YFC0844400）