新型冠状病毒感染疫情防控背景下基于远程监察的中医临床研究数据质量控制方法  

Data quality control methods of TCM clinical research based on remote monitoring in the background of COVID-19 prevention and control

作　　者：吕晓颖[1] 何丽云[1] 雒琳[1] 文天才[2] 王鑫[1] 王启桢 李洪皎[1] LYU Xiaoying;HE Liyun;LUO Lin;WEN Tiancai;WANG Xin;WANG Qizhen;LI Hongjiao(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Chinese Medicine Data Center,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院中医药数据中心

出　　处：《北京中医药大学学报》2023年第3期340-346,共7页Journal of Beijing University of Traditional Chinese Medicine

基　　金：中国中医科学院科技创新工程中医临床基础学科创新团队项目(No.CI2021B003);国家重点研发计划重点专项(No.2020YFC0845000-5);科学技术部国家重大科技专项——传染病专项(No.2017ZX10106001);中央级公益性科研院所基本科研业务费专项资金资助项目(No.ZZ14-YQ-037)。

摘　　要：针对新型冠状病毒感染疫情采取的各项隔离措施在有效切断病毒传播的同时,也影响了第三方在中医临床研究中的现场监察,因此远程数据质量控制成为临床研究过程中亟需解决的问题。本文依据“十三五”中医药防治重大传染病专项及新型冠状病毒感染期间的远程数据质量控制经验,结合国内外临床研究中的相关法规要求,按照临床研究质量可溯源性(attributable)、清晰性(legible)、同时性(cotemporaneous)、原始性(original)和准确性(accurate)的ALCOA标准和完整性(complete)、一致性(consistent)、持久性(enduring)、可用性(available)的CCEA标准,从实践出发,详述了数据核查的计划、要点和方式,以及两种数据质量评估方法。介绍了集约电子数据平台的优势,以及如何利用电子数据平台远程控制试验进度和数据质量的管理方法,以期日后临床研究者可以通过电子数据平台和批量化的电子数据处理,减少现场接触,为有效提高数据质量提供保障。Isolation measures for COVID-19 not only effectively cut off viral transmission,but also affected the on-site monitoring of the third party in traditional Chinese medicine(TCM)clinical research.Therefore,remote data quality control has become an urgent problem in clinical research.The present research is based on the Major Program of"the 13th Five-Year Plan"for the prevention and treatment of severe infectious diseases with TCM and the experiences of remote data quality control during the COVID-19 epidemic.Based on the relevant regulatory requirements of clinical research in China and abroad,according to the clinical research quality standards of ALCOA(attributable,legible,contemporaneous,original,accurate)and CCEA(complete,consistent,enduring,available),and from a practical perspective,in the present study we elaborate on the plan,key points,and method of data verification,as well as two methods of data quality assessment.We introduce the advantages of the intensive electronic data platform and discuss how to use the platform to remotely control the trial progress and data quality management method,in order to provide an opportunity for clinical researchers to reduce on-site contact with patients and effectively improve data quality through an electronic data platform and mass electronic data processing.

关 键 词：中医药 新型冠状病毒感染 临床研究 远程监察 数据质量 

分 类 号：R2-03[医药卫生—中医学]