藥物臨床試驗(yàn)資料是記錄臨床試驗(yàn)全過程所產(chǎn)生的信息，是臨床試驗(yàn)的重要部分，客觀反映研究者、申辦者及監(jiān)察員對(duì)藥物臨床試驗(yàn)質(zhì)量管理的依從性，是藥品監(jiān)督管理部門進(jìn)行監(jiān)察、新藥審批的關(guān)鍵資料。著重分析臨床試驗(yàn)各個(gè)階段資料管理的難點(diǎn)，根據(jù)實(shí)踐經(jīng)驗(yàn)針對(duì)問題探討相應(yīng)對(duì)策。建議從完善檔案制度及檔案管理標(biāo)準(zhǔn)操作規(guī)程、提高資料管理員水平、利用信息化手段3個(gè)方面來提高資料管理水平。

The clinical trial document contains information generated during the whole process of clinical trials, which objectively reflects the compliance of researchers, the sponsors and the supervisors on the quality management of drug clinical trials, as the key information and basis for drug supervision and management departments to monitor and approve new drugs. This paper focuses on analyzing the difficulties of data management in various stages of clinical trials, and probes into corresponding countermeasures according to practical experience. We suggest to improve the data management level from three aspects:perfecting the file system and file management standard operating procedures, improving the level of data administrators, and using information technology.