T/CGCPU 003-2023
Specification for capacity evaluation of clinical trial institutions (English Version)

Standard No.

T/CGCPU 003-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 003-2023

Scope

Preface Introduction 1. Scope 2. Normative cited documents 3 Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations 4 Assessment content 4.1 Basic conditions and capabilities of institutions to undertake clinical trials 4.2 Clinical trial institution capability assessment content 5 Assessment expert group 6 .Assessment process 6.1 Assessment process development 6.2 Pre-assessment work flow 6.3 On-site assessment process 6.4 Issuance of assessment report 7 Result determination 7.1 Assessment content determination 7.2 Assessment conclusion Appendix A (normative) Clinical trial institution capacity assessment content Appendix B (normative) Assessment Panel References

T/CGCPU 003-2023 history

• 2023 T/CGCPU 003-2023 Specification for capacity evaluation of clinical trial institutions
• 2019 T/CGCPU 003-2019 Clinical Trial Institution Capacity Evaluation Standards