GB 3232-1982
Abolished
T/CGCPU 003-2022
Active
Group standards
T/CGCPU 003-2022 The Standards for Evaluation of Clinical Trial Capabilities
T/CGCPU 003-2022 The Standards for Evaluation of Clinical Trial Capabilities
Price:
$ 20.00
Basic Information
Standard Code:
T/CGCPU 003-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical science and healthcare devices
Publish Date:
2022-12-13
Implement Date:
2022-12-26
Scope
Main technical content: Foreword Introduction 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations 4. Evaluation content 4.1 Basic conditions and capabilities of institutions undertaking clinical trials 4.2 Evaluation content of clinical trial institutions' capabilities 5. Evaluation expert group 6. Evaluation process 6.1 Establishment of evaluation process 6.2 Pre-evaluation workflow 6.3 On-site evaluation process 6.4 Issuance of evaluation reports 7. Result determination 7.1 Determination of clauses in the evaluation content 7.2 Evaluation conclusion Appendix A (normative) Evaluation content of clinical trial institutions' capabilities Appendix B (normative) Reference documents for evaluation expert groups
Development Information
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