SHEN Wenjuan, ZHANG Yuehui, ZHANG Duojia, et al. Implementation Process Standardization of International Clinical Trials and Its Application in Chinese Medicine Field[J]. Journal of Traditional Chinese Medicine2018, 59(8): 649-653.
SHEN Wenjuan, ZHANG Yuehui, ZHANG Duojia, et al. Implementation Process Standardization of International Clinical Trials and Its Application in Chinese Medicine Field[J]. Journal of Traditional Chinese Medicine2018, 59(8): 649-653.DOI: 10.13288/j.11-2166/r.2018.08.006.
The standardized implementation of clinical research is an important guarantee to evaluate the effectiveness of the study protocol. This article is to summarize the organization structure and research process of international clinical trial implementation. Taking impact of acupuncture combined with clomiphene on polycystic ovarian syndrome anovulation women’ s live birth: international cooperative randomized controlled trial( PCOSAct) for example
this article introduces exploration and innovation of standardization implementation in department of gynaecology in First Hospital Affiliated to Heilongjiang University of Chinese Medicine in the process of clinical research of Chinese medicine
by adopting internationalized organizational management model
emphasizing the implementation preparation
emphasizing ethics retrial and registration update
regular meeting of steering committee
as well as adopting the methods of site inspection and international joint inspection
to provide reference for Chinese medicine clinical research internationalization.