T/CGCPU 008-2019 General Inspection Standards for Clinical Trials

Scope

Scope: The general audit standards for clinical trials cover aspects such as clinical trial conditions and compliance audits, clinical trial project audits, and quality and risk management audits. This standard applies to the audit of drug/medical device clinical trials, including Phase I to III drug clinical trials, human bioequivalence trials, biological sample testing and analysis audits, and clinical trials of medical devices/in vitro diagnostic reagents. 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 Ethics committee 3.1.3 Sponsor 3.1.4 Investigator 3.1.5 Contract research organization (CRO) 3.1.6 Subject 3.1.7 Informed consent 3.1.8 Protocol 3.1.9 Independent data monitoring committee (IDMC) 3.1.10 Case report form (CRF) 3.1.11 Standard operating procedures (SOP) 3.1.12 Investigational product 3.1.3 Adverse event (AE) 3.1.4 Serious adverse event (SAE) 3.1.5 Suspected unexpected serious adverse reaction (SUSAR) 3.1.6 Certified copy 3.1.7 Quality assurance (QA) 3.1.8 Quality control (QC) 3.1.9 Monitoring 3.1.10 Audit 3.2 Abbreviations 4. Contents of clinical trial audits 5. Judgment of audit results Appendix A (normative appendix) Audit contents Part I: Clinical trial conditions and compliance audits (including the implementation of responsibilities by all parties in the clinical trial project) Part II: Clinical trial project audits Part III: Quality and risk management audits

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