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

LYU Xiaoying; HE Liyun; LUO Lin; WEN Tiancai; WANG Xin; WANG Qizhen; LI Hongjiao

doi:10.3969/j.issn.1006-2157.2023.03.010

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

TCM Informatics | 更新时间：2023-04-07

- Data quality control methods of TCM clinical research based on remote monitoring in the background of COVID-19 prevention and control
- Journal of Beijing University of Traditional Chinese Medicine Vol. 46, Issue 3, Pages: 340-346(2023)
- 作者机构：
  
  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
- 作者简介：
  
  LI Hongjiao, Ph.D., Associate Researcher, Master’s Supervisor.Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16, Nanxiao Street, Inside Dongzhimen, Dongcheng District, Beijing 100700. E-mail: lhjiao2013@163.com
- 基金信息：
  
  Major Project of National Key Research and Development Program of China(CI2021B003);National Science and Technology Major Project of Ministry of Science and Technology of the People’s Republic of China–Infectious Disease Program(2020YFC0845000-5)
- DOI：10.3969/j.issn.1006-2157.2023.03.010
  CLC： R2-03
- Received：13 July 2022，
  
  Published：30 March 2023
- 稿件说明：
移动端阅览
LYU Xiaoying, HE Liyun, LUO Lin, et al. Data quality control methods of TCM clinical research based on remote monitoring in the background of COVID-19 prevention and control[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(3): 340-346.
DOI：

LYU Xiaoying, HE Liyun, LUO Lin, et al. Data quality control methods of TCM clinical research based on remote monitoring in the background of COVID-19 prevention and control[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(3): 340-346. DOI： 10.3969/j.issn.1006-2157.2023.03.010.

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。

Abstract

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

Keywords

references

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