T/CGCPU 023-2023 Active Group standards

T/CGCPU 023-2023 Systematic review of clinical trial management system documents specification

Publish Date: 2023-01-01 Implement Date: 2023-01-10 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/CGCPU 023-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2023-01-01

Implement Date: 2023-01-10

Scope

Main technical content: - Preface - Introduction - Scope - Normative reference documents - Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations - Evaluation content 4.1 Overall requirements for the organization's clinical trial management system documents 4.2 Evaluation content of the organization's clinical trial management system documents - Evaluation experts - Evaluation process - Result determination 7.1 Grading of evaluation conclusions 7.2 Clause explanation 7.3 Score calculation - Appendix A (normative): Evaluation content of the organization's clinical trial management system documents - Appendix B (normative): Specific requirements for the evaluation expert group - References

Development Information

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