[關(guān)鍵詞]
[摘要]
紙質(zhì)記錄是在臨床試驗(yàn)活動(dòng)中記錄和產(chǎn)生的、可完整重現(xiàn)和評(píng)估相應(yīng)活動(dòng)的原始記錄,是闡明所取得結(jié)果或提供完成試驗(yàn)的證據(jù)。盡管電子化文件在臨床試驗(yàn)中已經(jīng)被廣泛采用,但是紙質(zhì)文件仍然是中國(guó)臨床試驗(yàn)記錄的主要方式之一。但是當(dāng)前我國(guó)臨床試驗(yàn)紙質(zhì)記錄受控管理并未形成共識(shí),同時(shí)不同機(jī)構(gòu)之間的操作也存在較大差異,在一定程度上對(duì)臨床試驗(yàn)的質(zhì)量產(chǎn)生不利影響。通過全面梳理國(guó)內(nèi)外紙質(zhì)記錄受控管理相關(guān)的法規(guī)及實(shí)踐,同時(shí)結(jié)合工作實(shí)踐提出了相應(yīng)的解決策略,以期推動(dòng)我國(guó)臨床試驗(yàn)紙質(zhì)文件受控管理,全面提升藥物臨床研究的質(zhì)量。
[Key word]
[Abstract]
Paper records are the original and reproducible documentation recorded and generated during clinical trials, with which elucidates obtained results and provide evidence in trial inspection. Although electronic data has been widely used in clinical trials, paper documents are still one of the main methods of recording clinical trials in China. Currently, there is considerable debate about controlled management of paper records in clinical trials within China. Meanwhile,there are significant differences in the practice of different institutions, which to some extent affects the clinical trial quality. This paper proposed corresponding strategies based on work practice by referring to domestic and foreign regulations and practices related to the controlled management of paper records in order to promote the comprehensive improvement of clinical research quality in this field.
[中圖分類號(hào)]
[基金項(xiàng)目]
上海市中醫(yī)藥“三年行動(dòng)計(jì)劃”資助項(xiàng)目[ZY(2021-2023)-0211];上海市“科技創(chuàng)新行動(dòng)計(jì)劃”生物醫(yī)藥科技支撐專項(xiàng)(20S21902100);上海市教委協(xié)同創(chuàng)新中心中西醫(yī)結(jié)合-中成藥臨床評(píng)價(jià)平臺(tái)(A1-U21-205-0103);上海市申康中心示范性研究型病房建設(shè)(SHDC2022CRW010);上海市申康中心醫(yī)企融合創(chuàng)新協(xié)同專項(xiàng)(SHDC2022CRT018);上海市慢性筋骨病臨床醫(yī)學(xué)研究中心項(xiàng)目(20MC1920600);上海市科委2022年度第三批應(yīng)急科技攻關(guān)項(xiàng)目(22YJ1900505)