[關(guān)鍵詞]
[摘要]
目的 構(gòu)建基于質(zhì)量管理體系要求ISO9001：2015的藥物臨床試驗機構(gòu)的質(zhì)量管理評價體系。方法 采用專家調(diào)查法邀請14名專家進行2輪咨詢，確定各級指標，使用層次分析法計算各指標的權(quán)重。結(jié)果 建立了4個一級指標、15個二級指標和46個三級指標的藥物臨床試驗機構(gòu)質(zhì)量管理評價體系；一級指標領(lǐng)導(dǎo)與策劃、支持與運行、效果評估、持續(xù)改進的權(quán)重分別為0.2103、0.3303、0.1835、0.2759；二級指標中組合權(quán)重排前3位的分別為預(yù)防和糾正（0.1554）、領(lǐng)導(dǎo)力（0.1143）、機構(gòu)定期開展質(zhì)控檢查（0.0806）；三級指標中組合權(quán)重排前3位的為定期進行預(yù)防和糾正效果評估（0.0696）、有對應(yīng)的數(shù)據(jù)或舉措體現(xiàn)改進效果（0.0487）、具有藥物臨床試驗質(zhì)量管理要求和指引（0.0378）。結(jié)論 構(gòu)建的質(zhì)量管理評價體系具有一定的科學(xué)性、實用性，可用于評估藥物臨床試驗機構(gòu)的質(zhì)量管理能力。
[Key word]
[Abstract]
Objective To establish the quality management evaluation systems for drug clinical trial institutions based on ISO9001:2015. Methods Using the Delphi method, 14 experts will be invited to conduct two rounds of consultation to determine the indicators at all levels, and the weight of each indicator will be calculated using the analytic hierarchy process. Results A quality management evaluation system for drug clinical trial institutions was established with 4 first-level indicators, 15 second-level indicators, and 46 third-level indicators. The weights of leadership and planning, support and operation, effect evaluation, and continuous improvement of the first-level indicators are 0.2103, 0.330 3, 0.1835, and 0.2759, respectively. The top three combined weights in the second-level indicators are prevention and correction (0.1554), leadership (0.1143), and the institution regularly conducts quality control inspections (0.0806). Among the three-level indicators, the top three in combination weights are regularly evaluated for preventive and corrective effects (0.069 6), with corresponding data or measures to reflect the improvement effect (0.0487), and with requirements and guidelines for quality management of drug clinical trials (0.0378). Conclusion The established quality management evaluation systems is scientific and practical, which can be used to evaluate the quality management ability of drug clinical trial institutions.
[中圖分類號]
R954
[基金項目]
廣東省科技創(chuàng)新戰(zhàn)略專項資金（廣東省基礎(chǔ)與應(yīng)用基礎(chǔ)研究基金自然科學(xué)基金）項目（2020A1515011134）；廣州市哲學(xué)社會科學(xué)規(guī)劃2020年度共建課題（2020GZGJ130）
