GB 3232-1982
Abolished
T/CGCPU 006-2023
Active
Group standards
T/CGCPU 006-2023 I phase clinical trial capability evaluation specification
T/CGCPU 006-2023 I phase clinical trial capability evaluation specification
Price:
$ 20.00
Basic Information
Standard Code:
T/CGCPU 006-2023
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: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions, acronyms 3.1 Terms and definitions 3.2 Acronyms 4 Evaluation content 4.1 Phase I clinical trial evaluation content 4.2 Phase I clinical trial capability evaluation 5 Evaluation experts 6 Evaluation process 6.1 Establishment of the evaluation process 6.2 Pre-evaluation workflow 6.3 On-site evaluation process 6.4 Issuance of the evaluation report 7 Result determination 7.1 Determination of clauses in the evaluation content 7.2 Evaluation conclusion Appendix A (Normative) Evaluation content and evaluation grades Appendix B (Normative) Specific requirements for the evaluation expert group References
Development Information
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