T/CGCPU 002-2023
Evaluation standard of centralized management of clinical investigational product (English Version)

Standard No.

T/CGCPU 002-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 002-2023

Scope

Preface Introduction 1 Scope 2 Normative cited documents 3 Terms and definitions, abbreviations 4 Evaluation content 4.1 Centralized management evaluation of clinical investigational drugs 4.2 Satellite pharmacy evaluation of clinical investigational drugs 5 Evaluation experts 6 Evaluation process 7 Result evaluation 7.1 Evaluation conditions 7.2 Evaluation Clause 7.3 Evaluation Conclusion Appendix A (Normative) Clinical Investigation Drug Centralized Management Evaluation Content Appendix B (Normative) Clinical Investigation Drug Satellite Pharmacy Evaluation Content Appendix C (Normative) Evaluation Expert Group Specific Requirements References

T/CGCPU 002-2023 history

• 2023 T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
• 2016 T/CGCPU 002-2016 The standard of on-site inspection for clinical investigational drug centralized management