GB 3232-1982
Abolished
T/CGCPU 006-2022
Active
Group standards
T/CGCPU 006-2022 The standard for evaluating clinical trial capability phase I
T/CGCPU 006-2022 The standard for evaluating clinical trial capability phase I
Price:
$ 20.00
Basic Information
Standard Code:
T/CGCPU 006-2022
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: - Preface - 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 Phase I clinical trial evaluation content 4.2 Phase I clinical trial capacity 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 conclusions - Appendix A (normative) Evaluation content and evaluation levels - Appendix B (normative) Specific requirements for the evaluation expert group - References
Development Information
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