T/CGCPU 001-2022 Active Group standards

T/CGCPU 001-2022 Capacity Assessment Standards for Clinical Research Coordinators (CRCs)

T/CGCPU 001-2022

Publish Date: 2022-12-14 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 001-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Terminology (principles and coordination and cooperation)

Publish Date: 2022-12-14

Implement Date: 2022-12-26

Scope

Main technical content: Foreword Introduction 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 4. Basic requirements for CRC professionals 4.1 Academic and professional requirements 4.2 Ethical requirements 4.3 Knowledge and competency requirements 5. CRC professional training requirements 5.1 Pre-job training 5.2 Continuing education 6. CRC professional level assessment 6.1 CRC professional level 7. Assessment experts 8. Assessment process 8.1 Development of assessment process 8.2 Issuance of assessment reports 8.3 Determination of assessment results Appendix A (normative) CRC practice assessment content Appendix B (informative) CRC industry work requirements Appendix C (informative) Qualification requirements for assessment experts References