T/CACM 1353-2021 Active Group standards

T/CACM 1353-2021 The technical specifications for the design and evaluation of clinical randomized controlled trials of traditional Chinese medicine for the treatment of carotid atherosclerosis

Publish Date: 2021-03-16 Implement Date: 2021-03-16 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 1353-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Health

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2021-03-16

Implement Date: 2021-03-16

Scope

Main technical content: Preface Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions 4 Design and evaluation techniques 4.1 Clinical positioning 4.2 Overall trial design 4.3 Diagnostic criteria 4.4 Differential diagnosis criteria 4.5 Subject selection and withdrawal 4.6 Drug administration scheme 4.7 Efficacy evaluation 4.8 Safety observation 4.9 Trial quality control 4.10 Ethical requirements Appendix A (informative) Diagnostic criteria for carotid artery atherosclerosis Appendix B (informative) MR imaging evaluation of carotid artery plaques Appendix C (informative) TCM differential diagnosis criteria for carotid artery atherosclerosis Appendix D (informative) Criterion-based quantitative grading list of carotid artery atherosclerosis symptoms References

Development Information

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