T/CGCPU 022-2022 Active Group standards

T/CGCPU 022-2022 Guidelines for the Evaluation of Clinical Trial Informatization Management

T/CGCPU 022-2022

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 022-2022
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Integrated medical science and healthcare devices
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 4 Assessment content 4.1 Basic conditions and capabilities 5 Assessment process 5.1 Establishment of the assessment process 5.2 On-site assessment process 5.3 Issuance of the assessment report 5.4 Self-assessment process of the institution 6 Result determination 6.1 Assessment clauses 6.2 Assessment conclusions Appendix A (normative) Assessment content Appendix B (normative) Requirements for the assessment expert group References

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