試驗(yàn)用藥品在規(guī)定的溫度條件下運(yùn)輸和儲(chǔ)存是保證試驗(yàn)用藥品質(zhì)量的前提，是藥物臨床試驗(yàn)數(shù)據(jù)和結(jié)果真實(shí)、可靠的基礎(chǔ)。通過查閱《藥物臨床試驗(yàn)質(zhì)量管理規(guī)范》《藥物臨床試驗(yàn)數(shù)據(jù)現(xiàn)場(chǎng)核查要點(diǎn)》《中國藥典》《美國藥典》和相關(guān)國內(nèi)外文獻(xiàn)，結(jié)合本機(jī)構(gòu)試驗(yàn)用藥物管理模式的特點(diǎn)，探索試驗(yàn)用藥品冷鏈管理的關(guān)鍵環(huán)節(jié)，實(shí)現(xiàn)試驗(yàn)用藥品冷鏈的閉環(huán)管理，減少超溫事件的發(fā)生。介紹本機(jī)構(gòu)試驗(yàn)用藥品的冷鏈管理經(jīng)驗(yàn)，為藥物臨床試驗(yàn)機(jī)構(gòu)進(jìn)行試驗(yàn)用藥品的冷鏈管理提供借鑒和參考。

The transportation and storage of investigational drugs under specified temperature conditions is the premise of ensuring the quality of investigational drugs, and is the basis for the authenticity and reliability of drug clinical trial data and results. By consulting "Good Clinical Practice for Drugs", "Key Points for On-site Inspection of Drug Clinical Trial Data", "Chinese Pharmacopoeia", "US Pharmacopoeia", and related domestic and foreign documents, combined with the characteristics of investigational drug management model, we explore the key links of cold chain management of investigational drugs, realize closed-loop management of cold chain of investigational drugs, and reduce the occurrence of over-temperature events. This article introduces the cold chain management experience of investigational drugs, and provides reference for the cold chain management of investigational drugs in drug clinical trial institutions.

R965.2

北京市醫(yī)院管理中心“青苗”計(jì)劃專項(xiàng)經(jīng)費(fèi)資助項(xiàng)目（QMS20200811）；北京市醫(yī)院管理中心“登峰”計(jì)劃專項(xiàng)經(jīng)費(fèi)資助項(xiàng)目（DFL20190803）；首都科技領(lǐng)軍人才項(xiàng)目（Z191100006119017）