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Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies / 中国结合医学杂志
Article in English | WPRIM | ID: wpr-888672
Responsible library: WPRO
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.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline Language: English Journal: Chinese journal of integrative medicine Year: 2021 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline Language: English Journal: Chinese journal of integrative medicine Year: 2021 Type: Article