基于ISO9001：2015的药物临床试验机构质量管理评价体系的构建

目的 构建基于质量管理体系要求ISO9001：2015的药物临床试验机构的质量管理评价体系。方法 采用专家调查法邀请14名专家进行2轮咨询，确定各级指标，使用层次分析法计算各指标的权重。结果 建立了4个一级指标、15个二级指标和46个三级指标的药物临床试验机构质量管理评价体系；一级指标领导与策划、支持与运行、效果评估、持续改进的权重分别为0.2103、0.3303、0.1835、0.2759；二级指标中组合权重排前3位的分别为预防和纠正（0.1554）、领导力（0.1143）、机构定期开展质控检查（0.0806）；三级指标中组合权重排前3位的为定期进行预防和纠正效果评估（0.0696）、有对应的数据或举措体现改进效果（0.0487）、具有药物临床试验质量管理要求和指引（0.0378）。结论 构建的质量管理评价体系具有一定的科学性、实用性，可用于评估药物临床试验机构的质量管理能力。

Construction of quality management evaluation systems for drug clinical trial institutions based on ISO9001:2015

Objective To establish the quality management evaluation systems for drug clinical trial institutions based on ISO9001:2015. Methods Using the Delphi method, 14 experts will be invited to conduct two rounds of consultation to determine the indicators at all levels, and the weight of each indicator will be calculated using the analytic hierarchy process. Results A quality management evaluation system for drug clinical trial institutions was established with 4 first-level indicators, 15 second-level indicators, and 46 third-level indicators. The weights of leadership and planning, support and operation, effect evaluation, and continuous improvement of the first-level indicators are 0.2103, 0.330 3, 0.1835, and 0.2759, respectively. The top three combined weights in the second-level indicators are prevention and correction (0.1554), leadership (0.1143), and the institution regularly conducts quality control inspections (0.0806). Among the three-level indicators, the top three in combination weights are regularly evaluated for preventive and corrective effects (0.069 6), with corresponding data or measures to reflect the improvement effect (0.0487), and with requirements and guidelines for quality management of drug clinical trials (0.0378). Conclusion The established quality management evaluation systems is scientific and practical, which can be used to evaluate the quality management ability of drug clinical trial institutions.