T/CGCPU 023-2022
Active
Group standards
T/CGCPU 023-2022 Systematic review of clinical trial management system documents
T/CGCPU 023-2022 Systematic review of clinical trial management system documents
Price:
$ 20.00
Basic Information
Standard Code:
T/CGCPU 023-2022
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 1 Scope 2 Normative reference documents 3 Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations 4 Evaluation content 4.1 Overall requirements for the organization's clinical trial management system documents 4.2 Evaluation content of the organization's clinical trial management system documents 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) Evaluation content of the organization's clinical trial management system documents Appendix B (Normative) Specific requirements for the evaluation expert group References
Development Information
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