该文制定项目实施质量评分标准，应用PDCA理论对医疗器械临床试验质量展开专项整治活动。科室2011年1月至2012年12月期间完成的试验10项为对照组，2013年1月至2014年12月期间完成的9项为PDCA整治组，统计临床试验质量得分以及各要素的得分情况。结果显示PDCA整治组试验质量得分高于对照组（81分 vs.51分，P<0.001）。除不良事件外的各质量要素得分均高于对照组（P<0.001）。本科室利用PDCA循环在医疗器械临床试验整治活动中采取的各项措施切实有效，临床试验质量得到显著提高。%PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81,P<0.001), score rate of items increased except adverse events (P<0.001). The special rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.
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