T/CACM 015.3-2017 Active Group standards

T/CACM 015.3-2017 Quality Control Standards for Clinical Research on Traditional Chinese Medicine

T/CACM 015.3-2017

Publish Date: 2017-11-14 Implement Date: 2017-11-14 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CACM 015.3-2017

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2017-11-14

Implement Date: 2017-11-14

Scope

Main technical content: In recent years, clinical research on traditional Chinese medicine (TCM) has been widely carried out. Good quality control during the research process is an important means to ensure the authenticity and reliability of research data, and it is also a key step for the results of TCM clinical research to gain international recognition. Developing and promoting scientifically feasible quality control standards for TCM clinical research can improve the quality and level of TCM clinical research in China and promote the international recognition of TCM clinical research results. This standard is based on advanced methods and concepts of quality control in international drug clinical research, and within the framework of laws and regulations and technical documents issued by relevant national management departments, it combines the characteristics of TCM itself, the actual situation in China, and past work experience to formulate quality control standards for TCM clinical research, providing technical guidance for issues related to quality control during the TCM clinical research process.

Development Information

Same series standard

T/CACM 015.1-2017 The standard for developing a randomized controlled clinical research protocol for traditional Chinese medicine T/CACM 015.2-2017 The establishment of standards for ethics review procedures for clinical research on traditional Chinese medicine The formulation of standard operating procedures for electronic data collection and management in traditional Chinese medicine clinical research according to T/CACM 015.4-2017 T/CACM 015.6-2017 Training and Management Standards for Chinese Herbal Medicine Clinical Research Coordinator T/CACM 015.7-2017 Statistical analysis of Chinese medicine clinical research operation technical specifications T/CACM 015.8-2017 Guidelines for the Management of Clinical Research Documents for Traditional Chinese Medicine Technical Specifications for the Management of Clinical Research Results of Traditional Chinese Medicine (T/CACM 015.9-2017) T/CACM 015.10-2017, Standards for the Management of Drugs Used in Clinical Research of Traditional Chinese Medicine Technical Specifications for the Preparation of Summary Reports on Clinical Research of Traditional Chinese Medicine (T/CACM 015.11-2017) T/CACM 015.12-2017, Standards for the Verification of Clinical Research on Traditional Chinese Medicine

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