T/CGCPU 005-2019 Assessment criteria for professional ability of clinical trial teams

Scope

Scope: The evaluation criteria for the clinical trial professional group's competence include the clinical trial professional research team, professional conditions and facilities and equipment, trial data management, management of investigational drugs/medical devices, systems and standard operating procedures (SOPs), clinical trial implementation, quality and risk management, etc. This evaluation standard is applicable to self-evaluation by clinical trial professional groups and/or on-site evaluations by third parties. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 3.1 Terms and definitions 3.1.1 Clinical trial 3.1.2 Investigator 3.1.3 Subject 3.1.4 Informed consent 3.1.5 Protocol 3.1.6 Case Report Form, CRF 3.1.7 Standard Operating Procedures, SOP 3.1.8 Investigational products 3.1.9 Adverse event 3.1.10 Serious adverse event 3.1.11 Quality control 3.2 Abbreviations 4. Evaluation content for the clinical trial professional group's competence 5. Determination of evaluation results Appendix A (Normative Appendix) Evaluation content and evaluation levels Part I: Clinical trial professional research team Part II: Professional conditions and facilities and equipment Part III: Trial data management Part IV: Management of investigational drugs/medical devices Part V: Systems and standard operating procedures Part VI: Clinical trial implementation Part VII: Quality and risk management

Development Information

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