T/CGCPU 006-2019 Phase I Clinical Trial Capacity Assessment Standards

Scope

Scope: The evaluation standards for Phase I clinical trial capabilities include the Phase I clinical trial research team, trial sites, environments and facilities, instruments and trial materials, systems and standard operating procedures (SOPs), management and implementation of clinical trials, quality and risk management, recordkeeping and document archiving, etc. This evaluation standard is applicable to self-evaluations by Phase I clinical trial research laboratories and/or on-site evaluations by third parties. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions, acronyms 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 (SOPs) 3.1.8 Investigational products 3.1.9 Adverse event (AE) 3.1.10 Serious adverse event (SAE) 3.1.11 Quality assurance (QA) 3.1.12 Quality control (QC) 3.1.13 Monitoring 3.1.14 Audit 3.2 Acronyms 4. Evaluation content for Phase I clinical trial capabilities 5. Judgment of evaluation results Appendix A (normative appendix): Evaluation content and evaluation levels Part I: Phase I clinical trial research team Part II: Trial sites, environments and facilities Part III: Instruments and trial materials Part IV: Systems and standard operating procedures (SOPs) Part V: Management and implementation of clinical trials Part VI: Quality and risk management Part VII: Recordkeeping and document archiving

Development Information

Related Standards