Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies

Jun LIU; Nian WANG; Hai-xia DANG; Bing-wei CHEN; Li ZHANG; Chong ZOU; Cheng-liang ZHONG; Ju-kai HUANG; Qiong LIU; Ya-nan YU; Meng JIANG; Wei-xiong LIANG; Qi-guang CHEN; Yong-yan WANG; Chun-ti SHEN; Zhong WANG; Zhong WANG

doi:10.1007/s11655-020-3439-2

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Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies

Regulation and Guideline | Updated：2021-09-01

- Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies
- Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies
- Chinese Journal of Integrative Medicine 2021年27卷第7期页码：483-489
- Affiliations：
  
  1.Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing (100700), China
  2.China Academy of Chinese Medical Sciences, Beijing(100700), China
  3.School of Public Health, Southeast University, Nanjing (210009), China
  4.Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing (100078), China
  5.Jiangsu Provincial Hospital of Traditional Chinese Medicine(Affiliated Hospital of Nanjing University of Traditional Chinese Medicine), Nanjing (210029), China
  6.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin(300381), China
  7.Guangdong Hospital of Traditional Chinese Medicine, Guangzhou (510120), China
  8.Changzhou Traditional Chinese Medicine Hospital, Changzhou, Jiangsu Province(213004), China
- Author bio：
  
  Prof. WANG Zhong, E-mail: zhonw@vip.sina.com
  Prof. WANG Zhong, E-mail: zhonw@vip.sina.com
- Funds：
  
  China National Key Program of New Drug Research and Development(2011ZX09304-07)
- DOI：10.1007/s11655-020-3439-2
  中图分类号：
- 纸质出版日期：2021-07-01，
  
  网络出版日期：2020-11-10，
  
  录用日期：2020-09-16
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Jun LIU, Nian WANG, Hai-xia DANG, 等. Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies[J]. Chinese Journal of Integrative Medicine, 2021,27(7):483-489.

Jun LIU, Nian WANG, Hai-xia DANG, et al. Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies[J]. Chinese Journal of Integrative Medicine, 2021,27(7):483-489.
Jun LIU, Nian WANG, Hai-xia DANG, 等. Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies[J]. Chinese Journal of Integrative Medicine, 2021,27(7):483-489. DOI： 10.1007/s11655-020-3439-2.

Jun LIU, Nian WANG, Hai-xia DANG, et al. Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies[J]. Chinese Journal of Integrative Medicine, 2021,27(7):483-489. DOI： 10.1007/s11655-020-3439-2.

摘要

Abstract

Although there is guidance from different regulatory agencies

there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently

a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12

2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs

which will further develop the scientific integrity and quality of clinical studies.

关键词

Keywords

data monitoring committeeChinese Medicine Data Monitoring Committeeclinical trialcommunity standardChinese medicine

references

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