Technical Specifications for the Management of Clinical Research Results of Traditional Chinese Medicine (T/CACM 015.9-2017)

Scope

Main technical content: Technology transfer is one of the important aspects of the entire process of drug clinical research. It guides drug clinical research work to be more closely integrated with the needs of economic and social development, and refines scientific and technological achievements that can be directly transformed into economic and social value, providing technical support for the economic development and transformation of pharmaceutical enterprises. Formulating relevant technical norms is conducive to research units reforming and improving the scientific evaluation and assessment mechanism, promoting the transfer and transformation of scientific and technological achievements, and filling the gaps in the management norms of clinical research results in traditional Chinese medicine. This standard refers to the scientific management mode and advanced concepts of domestic universities. Based on the research results of the scientific research special project "Research on Clinical Research System and Translation Application Model of Traditional Chinese Medicine for Chronic Diseases" (201107006) funded by the National Administration of Traditional Chinese Medicine, and under the guidance of relevant laws and regulations and technical documents such as the "Law of the People's Republic of China on Promoting the Transfer of Scientific and Technological Achievements", the "Law of the People's Republic of China on Scientific and Technological Progress", and the "Quality Management Regulations for Drug Clinical Trials" (Decree No. 3 of the National Medical Products Administration), combined with the characteristics of traditional Chinese medicine clinical research and the actual situation of China, this standard formulates technical norms for the management of scientific and technological achievements in traditional Chinese medicine clinical research, including general provisions, classification of achievements, evaluation of achievements, registration of achie

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