T/CACM 015.8-2017 Active Group standards

T/CACM 015.8-2017 Guidelines for the Management of Clinical Research Documents for Traditional Chinese Medicine

T/CACM 015.8-2017

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 015.8-2017

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Standardized management and general provisions

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2017-11-14

Implement Date: 2017-11-14

Scope

Main technical content: At present, the requirements for the management of clinical research documents for traditional Chinese medicine (TCM) vary greatly and take different forms, which are not conducive to the protection of subjects' privacy, the traceability and quality control of research, and the efficiency of TCM clinical research. Therefore, it is necessary to standardize these requirements. The Chinese Society of Traditional Chinese Medicine organized the formulation of the "Standards for the Management of Clinical Research Documents for Traditional Chinese Medicine", so that the collection and preservation of documents for TCM clinical research projects can be standardized and unified, thus protecting the privacy of subjects, facilitating the traceability of research data, and improving the efficiency of TCM clinical research.

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 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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