T/CGCPU 029-2023
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T/CGCPU 029-2023 The evaluation requirements for follow-up centers in primary clinical trials
Main technical content: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions, acronyms 3.1 Terms and definitions 3.2 Acronyms 4 Evaluation content 4.1 Qualifications for conducting clinical trials 4.2 Basic conditions 4.3 Capacity 5 Evaluation process 5.1 Pre-evaluation 5.2 On-site evaluation 5.3 End of on-site evaluation 5.4 After on-site evaluation 6 Evaluation conclusions 6.1 Evaluation clauses 6.2 Conclusion judgment 7 Continuous improvement 7.1 Development of improvement measures Appendix A (Normative) Evaluation content and evaluation grades References