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 Phase I clinical trial assessment content 4.2 Phase I clinical trial capability assessment 5 Assessment experts 6 Assessment process 6.1 Assessment process development 6.2 Pre-assessment work process 6.3 On-site assessment process 6.4 Issuance of assessment report 7 Result determination 7.1 Judgment of terms in assessment content 7.2 Assessment conclusion Appendix A (Normative) Assessment content and assessment level Appendix B (Normative) Specific requirements of the assessment expert group References
T/CGCPU 006-2023 history
2023T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
2019T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria