T/CGCPU 025-2023
Guideline of contract research organization (English Version)

Standard No.

T/CGCPU 025-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 025-2023

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 Clinical trial protocol design 4.2 Screening of clinical trial institutions and principal investigators 4.3 Clinical trial implementation process 4.4 Supervision of clinical trials Check 4.5 Risk-based monitoring/centralized monitoring 4.6 Clinical trial audit 4.7 Drug safety and pharmacovigilance 4.8 Clinical trial management 4.9 Protection of subjects’ rights and interests 4.10 Financial management 5 Evaluation content details 6 Evaluation conclusion judgment principles Appendix A (normative ) Evaluation Content Details Appendix B (Informative) Clinical CRO Evaluation Content References

T/CGCPU 025-2023 history

• 2023 T/CGCPU 025-2023 Guideline of contract research organization
• 2022 T/CGCPU 025-2022 Guideline of contract research organization