試驗藥品管理的重要性，在于這些藥物多未上市，其安全性和有效性有一定的不確定性。臨床試驗用藥品的管理和使用是否規(guī)范，直接影響到試驗結(jié)果的可靠性和受試者的用藥安全，同時也是藥監(jiān)部門每次檢查臨床試驗的重要內(nèi)容。試驗用藥品具體管理流程包括藥品的接收、存儲、發(fā)放、回收等諸多環(huán)節(jié)，在管理上任何一個環(huán)節(jié)的疏忽，都會對整個試驗產(chǎn)生生嚴(yán)重影響，甚至導(dǎo)致試驗失敗。為此，應(yīng)建立試驗藥品管理制度，配備相應(yīng)的儲存設(shè)施和條件，并對試驗藥品管理人員進行培訓(xùn)。不論對臨床試驗的設(shè)計者、研究者、管理者而言，認(rèn)識到試驗藥品管理的重要性，對于提高臨床試驗質(zhì)量，保障受試者的用藥安全都大有裨益。

Importance of test drug management is that many of these drugs are not listed, and their safety and effectiveness have some uncertainty. The trials of the drug management and the use of standard or not, directly relate to the reliability of the test results and the life safety of subjects, but also the administration of each examination is the important content for the clinical trials. The procedure of management in the trials includes receiving, storage, issuance of drug, recycling, as well as many other links. A link to any management oversight will result in the serious influence on the whole trials and even lead to the failure. Therefore, the drug management system for clinical trials equipped with storage facilities and the appropriate conditions should be establishe, and training to the test drug management should be carried on. No matter to the designers, researchers, or managers of the clinical trials, recognizing the importance of the drug management and improving the quality of clinical trials are of the great advantage to guarantee the safety of the subjects drug.

“十二五”重大新藥創(chuàng)制項目（2011ZX09302-006-03）