T/CGCPU 004-2023 Ethical Review Capability Assessment Guidelines

Scope

Main technical content: Foreword Introduction 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Evaluation content 4.1 Ethics committee review capacity and efficiency 4.2 Ethics committee review capacity assessment 5. Evaluation process 5.1 Process formulation 5.2 On-site evaluation process 5.3 Comprehensive assessment 5.4 Feedback on issues 5.5 Evaluation report 5.6 Self-evaluation process of clinical trial institutions 6. Result determination 6.1 Determination method of evaluation clauses 6.2 Evaluation conclusion 6.3 Determination standards 6.4 Continuous improvement Appendix A (Normative) Evaluation clauses Appendix B (Informative) On-site interview outline Appendix C (Normative) Evaluation and continuous improvement Appendix D (Normative) Evaluation expert group References

Development Information

Related Standards