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. 2021 Jul;27(7):483-489.
doi: 10.1007/s11655-020-3439-2. Epub 2020 Nov 10.

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

Jun Liu  1 , Nian Wang  1 , Hai-Xia Dang  2 , Bing-Wei Chen  3 , Li Zhang  4 , Chong Zou  5 , Cheng-Liang Zhong  6 , Ju-Kai Huang  4 , Qiong Liu  1 , Ya-Nan Yu  1 , Meng Jiang  5 , Wei-Xiong Liang  7 , Qi-Guang Chen  3 , Yong-Yan Wang  1 , Chun-Ti Shen  8 , Zhong Wang  9 ; World Federation of Chinese Medicine Societies—Data Monitoring Committee for Clinical Studies
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Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies

Jun Liu et al. Chin J Integr Med. 2021 Jul.

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.

Keywords: Chinese Medicine Data Monitoring Committee; Chinese medicine; clinical trial; community standard; data monitoring committee.

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