T/CGCPU 029-2023
Evaluation requirements of follow-up centers for primary clinical trials (English Version)

Standard No.

T/CGCPU 029-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 029-2023

Scope

Preface Introduction 1 Scope 2 Normative cited documents 3 Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations 4 Evaluation content 4.1 Qualifications to undertake clinical trials 4.2 Basic conditions 4.3 Capabilities 5 Evaluation process 5.1 Pre-evaluation 5.2 On-site evaluation 5.3 On-site At the end of the evaluation 5.4 After the on-site evaluation is completed 6 Evaluation conclusion 6.1 Evaluation terms 6.2 Conclusion judgment 7 Continuous improvement 7.1 Develop improvement measures Appendix A (Normative) Evaluation content and evaluation grade References

T/CGCPU 029-2023 history

• 2023 T/CGCPU 029-2023 Evaluation requirements of follow-up centers for primary clinical trials