T/CGCPU 023-2023
Evaluation standard for clinical trial management system document (English Version)

Standard No.

T/CGCPU 023-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 023-2023

Scope

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 Overall setting requirements for institutional clinical trial management system documents 4.2 Institutional clinical trial management system document management assessment content 5 Evaluation experts 6 Assessment Process 7 Result Judgment 7.1 Grading of Assessment Conclusions 7.2 Description of Terms 7.3 Score Calculation Appendix A (Normative) Institutional Clinical Trial Management System Document Management Assessment Content Appendix B (Normative) Specific Requirements of the Assessment Expert Group References

T/CGCPU 023-2023 history

• 2023 T/CGCPU 023-2023 Evaluation standard for clinical trial management system document
• 2022 T/CGCPU 023-2022 Evaluation standard for clinical trial management system document