2024 年第 2 期 第 0 卷

北京市药品临床综合评价项目质量控制指南

Guideline for quality control of Beijing drug clinical comprehensive evaluation projectExpert 

作者：北京市药品使用监测和临床综合评价中心专家委员会

英文作者：Committee for Drug Use Monitoring and Clinical Comprehensive Evaluation of Beijing

单位：

英文单位：

关键词：药品临床综合评价；质量控制；指南

英文关键词：Clinicalcomprehensiveevaluationofdrugs;Qualitycontrol;Guidelines

• 摘要：

• 随着北京市各医疗机构药品临床综合评价工作的开展，亟需建立一套规范的、实用性强的药品临床综合评价质量控制体系。本指南从实际操作出发，梳理评价工作中可能导致研究不规范的环节和问题，总结相关经验，完善评价项目质量管理体系。从评价人员资质、项目设计和实施（主题遴选与备案、方案论证和实施、数据质量和安全）、结果转化（备案与中心评级）3个方面，提出药品临床综合评价项目的质量控制方法，以提高北京市药品临床综合评价工作的效率及质量，确保评价标准化、规范化实施。

• With the development of the clinical comprehensive evaluation of drugs in medical institutions in Beijing, it is urgent to establish a set of standardized and practical quality control system for the clinical comprehensive evaluation of drugs. This guideline sorts out the links and problems that may lead to non-standard research in the evaluation work, summarizes the relevant experience, and improves the quality management system of the evaluation project on the base of actual operation. This guideline proposes quality control methods for clinical comprehensive evaluation of drugs from three aspects: qualification of evaluation personnel, project design and implementation (including theme selection and filing, program demonstration and implementation, data quality and safety), and result transformation (filing and center rating), in order to promote the efficiency and quality of the clinical comprehensive evaluation of drugs in Beijing, and ensure the standardization of evaluation and standardized implementation.