T/CGCPU 023-2022 Active Group standards

T/CGCPU 023-2022 Systematic review of clinical trial management system documents

T/CGCPU 023-2022 Systematic review of clinical trial management system documents

Publish Date: 2022-12-14 Implement Date: 2022-12-26 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 023-2022
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2022-12-14
Implement Date: 2022-12-26

Scope

Main technical content: Foreword 1 Scope 2 Normative reference documents 3 Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations 4 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 5 Evaluation experts 6 Evaluation process 7 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

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