GB 3232-1982
Abolished
T/CGCPU 025-2022
Active
Group standards
T/CGCPU 025-2022 Clinical CRO Activity Guideline
T/CGCPU 025-2022 Clinical CRO Activity Guideline
Price:
$ 20.00
Basic Information
Standard Code:
T/CGCPU 025-2022
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: - Preface - Introduction - Scope - Normative reference documents - Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations - Evaluation content 4.1 Clinical trial protocol design 4.2 Selection of clinical trial institutions and principal investigators 4.3 Clinical trial implementation process 4.4 Clinical trial monitoring 4.5 Risk-based monitoring/centralized monitoring 4.6 Clinical trial inspection 4.7 Drug safety and pharmacovigilance 4.8 Clinical trial management 4.9 Protection of subjects' rights 4.10 Financial management - Detailed evaluation content - Evaluation conclusion determination principles - Appendix A (normative) Detailed evaluation content - Appendix B (informative) Clinical CRO evaluation content - References
Development Information
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