T/CACM 015.10-2017 Active Group standards

T/CACM 015.10-2017, Standards for the Management of Drugs Used in Clinical Research of Traditional Chinese Medicine

T/CACM 015.10-2017

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 015.10-2017

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Health

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2017-11-14

Implement Date: 2017-11-14

Scope

Main technical content: During the clinical research process, the management of study drugs runs through the entire research process. Strengthening the management of study drugs is one of the important links to avoid deviations in research results and ensure the quality of drug clinical research. With the strict supervision of clinical research by relevant national departments, the standardization and refinement of study drug management will be an issue that all clinical research institutions must pay attention to. In order to promote the standardized management of clinical research drugs, encourage drug clinical research institutions to standardize the management of clinical research drugs, improve management quality, ensure the standardization of the clinical research process and the scientific reliability of the results, and maximally protect the rights and health of subjects, this standard is established.

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 T/CACM 015.3-2017 Quality Control Standards 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) 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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