目的 利用智能樣本管理系統(tǒng)對早期藥物臨床試驗中發(fā)生血樣采集時間超窗的原因進行統(tǒng)計分析，提出改進措施。方法 以首都醫(yī)科大學宣武醫(yī)院和中國人民解放軍總醫(yī)院I期臨床研究中心在2019年5月—2021年10月開展的23個早期藥物臨床試驗中藥動學血樣采集相關數(shù)據(jù)為研究對象，統(tǒng)計血樣采集時間超窗的發(fā)生情況，并進行原因分析。結果 共納入23項臨床試驗，共計911例健康志愿者，總采血次數(shù)34 096次，血樣采集時間超窗發(fā)生101次，發(fā)生率為0.30%。血樣采集時間超窗的原因分別為采血困難、采血管負壓不足、受試者未遵守方案、研究人員因素等，其中采血困難是主要原因（51.49%）。結論 提高研究人員操作技能，使用智能樣本管理系統(tǒng)等措施可以減少血樣采集時間超窗的發(fā)生，提高臨床試驗質(zhì)量。

Objective To analyze the causes of beyond the specified time range of blood sample collection in early phase clinical trial based on the intelligent sample management system and propose improvement measures. Methods The data of blood sample collection in 23 early phase clinical trials were carried out by Phase I Clinical Research Center of Xuanwu Hospital Capital Medical University and Chinese PLA General Hospital from May 2019 to October 2021. The blood samples beyond the specified time range were counted, and the reasons were analyzed. Results There were 911 participants involved in 23 clinical trials, the total numbers of blood sample collection were 34 096 times, and the number of over time window was 101 (0.30%). The reasons were mainly difficulty in blood collection, insufficient negative pressure in blood collection tubes, subject non-compliance with protocol, and research staff factors. And difficulty in blood collection was the main reason (51.49%). Conclusion Improving investigators operational skills and using intelligent sample management system can reduce the occurrence of beyond the specified time range of blood sample collection, and improve the quality of clinical trial.

R965.2

北京市醫(yī)院管理中心“青苗”計劃專項經(jīng)費資助項目（QMS20200811）；首都科技領軍人才項目（Z191100006119017）；北京市醫(yī)院管理中心“登峰”計劃專項經(jīng)費資助項目（DFL20190803）