T/CGCPU 002-2022 Active Group standards

T/CGCPU 002-2022 The standard for centralized management and evaluation of clinical trial drugs

Publish Date: 2022-12-13 Implement Date: 2022-12-26 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CGCPU 002-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Terminology (principles and coordination and cooperation)

Publish Date: 2022-12-13

Implement Date: 2022-12-26

Scope

Main technical content: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions, abbreviations 4 Evaluation content 4.1 Evaluation of centralized management of drugs used in clinical trials 4.2 Evaluation of satellite pharmacies for drugs used in clinical trials 5 Evaluation experts 6 Evaluation process 7 Result evaluation 7.1 Evaluation conditions 7.2 Evaluation criteria 7.3 Evaluation conclusions Appendix A (normative) Evaluation content of centralized management of drugs used in clinical trials Appendix B (normative) Evaluation content of satellite pharmacies for drugs used in clinical trials Appendix C (normative) Specific requirements for evaluation expert groups References