2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_–_Clinical_Trials_Oversight_59页_670kb

The WHO Global Benchmarking Tool for Clinical Trials Oversight (GBT+Medical Devices, Clinical Trials Oversight: Indicators and Fact Sheets, Revision VI+MD version 1) provides a framework for evaluating national regulatory authorities' (NRAs) systems governing clinical trials. It focuses on ensuring patient safety, ethical standards, and regulatory efficiency through a structured assessment of legal, organizational, human resource, procedural, and monitoring components.

Key elements include:

• Legal Foundations (Indicator CT01): Requiring clear legal mandates for authorizing, regulating, and overseeing clinical trials, including adherence to international guidelines like Good Clinical Practices (GCP).
• Organizational Structure and Governance (Indicator CT02): Defining roles, responsibilities, and communication mechanisms among stakeholders, with provisions for advisory committees.
• Human Resources (Indicator CT03): Ensuring sufficient, trained, and experienced staff with defined duties and roles to perform oversight activities effectively.
• Procedural Processes (Indicator CT04): Establishing documented review procedures, including ethical committee involvement, nonclinical data assessment, and uniform evaluation criteria.
• Transparency and Accountability (Indicator CT05): Promoting public availability of trial information and clear funding mechanisms for oversight committees.
• Performance Monitoring (Indicator CT06): Implementing key performance indicators and tracking systems to measure regulatory output and timeliness.

The tool uses maturity levels (Not Implemented, Ongoing Implementation, Partially Implemented, Implemented) to rate compliance, supported by evidence from legal documents, guidelines, and operational records. It aligns with WHO standards and aims to enhance global regulatory capacity for ethical and scientific sound clinical trial oversight across medicinal products and medical devices.