T/CGCPU 003-2019 Clinical Trial Institution Capacity Assessment Standards

Scope

Scope: The evaluation standards for the competence of clinical trial institutions include the overall situation of clinical trial institutions, organizational management structures, quality and risk management, data and file management, management of investigational drugs/medical devices, auxiliary departments and laboratories related to clinical trials, and evaluation content such as systems and standard operating procedures (SOPs). This evaluation standard applies to self-evaluations by clinical trial institutions 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 Monitoring 3.1.6 Audit 3.1.7 Protocol 3.1.8 Case Report Form (CRF) 3.1.9 Standard Operating Procedures (SOPs) 3.1.10 Investigational drugs 3.1.11 Adverse event 3.1.12 Serious adverse event 3.1.13 Certified copy 3.1.14 Quality assurance (QA) 3.1.15 Quality control (QC) 3.2 Abbreviations 4. Evaluation content for the competence of clinical trial institutions 5. Determination of evaluation results Appendix A (Normative Appendix) Evaluation content and evaluation levels Part I: Overall situation of clinical trial institutions Part II: Organizational management structures Part III: Quality and risk management Part IV: Data and file management Part V: Management of investigational drugs/medical devices Part VI: Auxiliary departments and laboratories related to clinical trials Part VII: Systems and standard operating procedures (SOPs)

Development Information

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