T/CGCPU 004-2023
Specification for the assessment of IRB/IEC review capability (English Version)

Standard No.

T/CGCPU 004-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 004-2023

Scope

Preface Introduction 1. Scope 2. Normative cited documents 3. Terms and definitions 4. Assessment content 4.1 Ethics committee review capability and efficiency 4.2 Ethics committee review capability assessment 5. Assessment process 5.1 Process development 5.2 On-site assessment process 5.3 Comprehensive assessment 5.4 Question feedback 5.5 Evaluation report 5.6 Clinical trial institution self-assessment process 6. Result judgment 6.1 Evaluation clause judgment method 6.2 Evaluation conclusion 6.3 Judgment standard 6.4 Continuous improvement Appendix A (normative) Evaluation clause Appendix B (informative) On-site interview outline Appendix C (normative) ) Evaluation and Continuous Improvement Appendix D (Normative) Evaluation Expert Group References

T/CGCPU 004-2023 history

• 2023 T/CGCPU 004-2023 Specification for the assessment of IRB/IEC review capability
• 2019 T/CGCPU 004-2019 Ethics Committee Review Competency Assessment Criteria