GB 3232-1982
Abolished
T/CGCPU 012-2023
Active
Group standards
T/CGCPU 012-2023 Clinical Trial Institution Archives Management Evaluation Standards
T/CGCPU 012-2023 Clinical Trial Institution Archives Management Evaluation Standards
Price:
$ 20.00
Basic Information
Standard Code:
T/CGCPU 012-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical science and healthcare devices
Publish Date:
2023-01-01
Implement Date:
2023-01-10
Scope
Main technical content: Preface Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions, abbreviations 4 Evaluation content 4.1 Conditions and capabilities of institutional clinical trial file management 4.2 Evaluation of clinical trial institution file management 5 Evaluation experts 6 Evaluation process 7 Result determination 7.1 Grading of evaluation conclusions 7.2 Clause explanation 7.3 Score calculation Appendix A (normative) Detailed rules for clinical trial institution file management evaluation Appendix B (normative) Specific requirements for evaluation expert groups References
Development Information
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