T/CGCPU 005-2022 The standard for evaluating the competence of clinical trial professionals

Scope

Main technical content: - **Preface and Introduction** - **Scope** - **Normative Reference Documents** - **Terms and Definitions, Abbreviations** - **3.1 Terms and Definitions** - **3.2 Abbreviations** - **Evaluation Content** - **4.1 Evaluation of the Professional Group's Conditions and Capabilities** - **4.2 Evaluation of the Clinical Trial Professional Group's Capabilities** - **Evaluation Experts** - **Evaluation Process** - **Result Judgment** - **7.1 Evaluation Conclusions** - **7.2 Principles of Conclusion Judgment** - **7.3 Scoring Principles and Total Score Calculation** - **7.4 Issuance of Evaluation Conclusions** - **Appendix A (Normative): Evaluation Content and Evaluation Levels** - **Appendix B (Normative): Specific Requirements for the Evaluation Expert Group** - **References**

Development Information

Related Standards