從起草背景、制定依據(jù)、檢查內(nèi)容、評(píng)估標(biāo)準(zhǔn)、適用范圍、評(píng)分等級(jí)、結(jié)果評(píng)定等方面闡述《臨床研究藥物中心化管理現(xiàn)場(chǎng)評(píng)估標(biāo)準(zhǔn)》,以期能夠切實(shí)促進(jìn)臨床研究藥物標(biāo)準(zhǔn)化管理,提高藥物中心化管理水平。

The standard of on-site inspection for clinical investigational drug centralized management which elaborates from the drafting background, the establishment basis, the inspection content, the assessment standard, the application scope, the rating, the evaluation of the results, etc. The purpose is to improve the standardized management of clinical investigational drug and to push the construction of the frame and the model of the drug centralized management.