T/CGCPU 029-2023 Active Group standards

T/CGCPU 029-2023 The evaluation requirements for follow-up centers in primary clinical trials

T/CGCPU 029-2023 The evaluation requirements for follow-up centers in primary clinical trials

Publish Date: 2023-12-31 Implement Date: 2024-01-16 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: T/CGCPU 029-2023
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2023-12-31
Implement Date: 2024-01-16
Pages: 16 pages

Scope

Main technical content: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions, acronyms 3.1 Terms and definitions 3.2 Acronyms 4 Evaluation content 4.1 Qualifications for conducting clinical trials 4.2 Basic conditions 4.3 Capacity 5 Evaluation process 5.1 Pre-evaluation 5.2 On-site evaluation 5.3 End of on-site evaluation 5.4 After on-site evaluation 6 Evaluation conclusions 6.1 Evaluation clauses 6.2 Conclusion judgment 7 Continuous improvement 7.1 Development of improvement measures Appendix A (Normative) Evaluation content and evaluation grades References

Development Information

Pages: 16 pages

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