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新型冠状病毒肺炎临床试验病例报告表及其使用说明 被引量:1

COVID-19 Clinical Trial Case Report Form and its Application Instructions
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摘要 新型冠状病毒肺炎(COVID-19)住院人数不断增加,国内已注册多项临床研究寻求有效的治疗方法。然而,如何提高不同试验间临床数据的可比性,提升临床试验数据收集效率,减少临床资源浪费,是疫情期间临床研究开展的关键问题之一。牛津大学国际严重急性呼吸系统和新发感染协会,针对COVID-19住院患者临床数据特征,开发了免费的电子版本病例报告表(electronic Case Record Form,eCRF),本文介绍了该eCRF的结构与内容,并详细介绍其使用方法。 The number of inpatients of COVID-19 is increasing,and a number of clinical studies have been registered in China to seek effective treatment.However,how to improve the comparability of clinical data between different trials,improve the efficiency of clinical trial data collection and reduce the waste of clinical resources is one of the key issues in clinical research during the epidemic.According to the clinical data characteristics of COVID-19 inpatients,Oxford University International Severe Acute Respiratory and emerging Infection Consortium has developed a free electronic version of case report form(eCRF).This paper introduces the structure and content of the eCRF and how to use it in detail.
作者 张晶晶 刘岩 陈莹 张晓雨 张学成 代恒恒 蒋寅 商洪才 Jing-Jing ZHANG;Yan LIU;Ying CHEN;Xiao-Yu ZHANG;Xue-Cheng ZHANG;Heng-Heng DAI;Yin JIANG;Hong-Cai SHANG(Dongzhimen Hospital,University of Chinese Medicine,Beijing 100700,China;Beijing University of Chinese Medicine,Beijing 100029,China;Guang'an Men Hospital,China Academy of Chinese Medical Science,Beijing 100053,China;International Evidence-Based Chinese Medicine Institute,Beijing University of Chinese Medicine,Beijing 100029,China.)
出处 《医学新知》 CAS 2020年第2期116-123,共8页 New Medicine
基金 国家自然科学基金杰出青年基金项目(81725024)。
关键词 新型冠状病毒 新型冠状病毒肺炎 病例报告表 临床试验 2019-nCoV COVID-19 Case report form Clinical trial
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