T/CGCPU 012-2023
Evaluation specifications for archives management of clinical trial institutions (English Version)

Standard No.

T/CGCPU 012-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/CGCPU 012-2023

Scope

Preface Introduction 1 Scope 2 Normative cited documents 3 Terms and definitions, abbreviations 4 Assessment content 4.1 Conditions and capabilities of institutional clinical trial archives management 4.2 Clinical trial institution archives management assessment 5 Assessment experts 6 Assessment process 7 Result determination 7.1 Assessment conclusion grading 7.2 Clause Description 7.3 Score Calculation Appendix A (Normative) Clinical Trial Institutional File Management Evaluation Rules Appendix B (Normative) Specific Requirements of the Evaluation Expert Group References

T/CGCPU 012-2023 history

• 2023 T/CGCPU 012-2023 Evaluation specifications for archives management of clinical trial institutions
• 2020 T/CGCPU 012-2020 File management standards for clinical trial institutions