T/CACM 1371.4-2021 Active Group standards

T/CACM 1371.4-2021 Ethical Review of Technical Standards for Real-world Research in Traditional Chinese Medicine

Publish Date: 2021-07-23 Implement Date: 2021-07-23 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 1371.4-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Research and development

Publish Date: 2021-07-23

Implement Date: 2021-07-23

Scope

Scope: This document specifies the technical norms for ethical review of the data collection, transfer, storage, utilization, and publication of real-world data used in clinical research. This document is applicable to personnel from drug approval agencies, medical institutions, enterprises, and research institutions when reviewing relevant types of research. Main technical content: This document specifies the technical norms for ethical review of the data collection, transfer, storage, utilization, and publication of real-world data used in clinical research. This document is applicable to personnel from drug approval agencies, medical institutions, enterprises, and research institutions when reviewing relevant types of research.

Development Information

Same series standard

T/CACM 1371.1-2021 The technical specifications for real-world research of traditional Chinese medicine: Database construction and data preprocessing T/CACM 1371.2-2021 Statistical analysis plan development for real-world studies in traditional Chinese medicine T/CACM 1371.3-2021 Chinese medicine real-world research technical specifications for evidence quality evaluation and reporting T/CACM 1371.5-2021 Evidence-based evaluation of the effectiveness and safety of traditional Chinese medicine in real-world studies

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