T/CGCPU 004-2019 Ethical Review Committee Review Capability Assessment Criteria

Scope

Scope: The evaluation criteria for the review of the ethical committee's capabilities include the organization and management of the ethical committee, institutional and standard operating procedures (SOPs), ethical review, and the management of data files, among other aspects. This evaluation standard applies to self-assessments by clinical trial ethics committees and/or on-site evaluations by third parties. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 3.1 Clinical trial 3.2 Ethics committee 3.3 Investigator 3.4 Subject 3.5 Sponsor 3.6 Informed consent 3.7 Informed consent form 3.8 Protocol 3.9 Standard operating procedures (SOPs) 3.10 Vulnerable persons 4. Evaluation criteria for the review of the ethical committee's capabilities 5. Determination of evaluation results Appendix A (normative appendix): Evaluation content and evaluation levels Part I: Organization and management of the ethical committee Part II: Institutional and standard operating procedures Part III: Ethical review Part IV: Management of data files

Development Information

Related Standards