摘要
目的 通过对某医疗机构体外诊断试剂临床试验质量控制过程中发现的问题进行分析,为其他医疗机构规范开展临床试验提供参考.方法 回顾性收集某机构质控中发现的问题,依据体外诊断试剂临床试验现场检查要点,对报告中的问题进行归纳和原因分析.结果 2022年5月至2023年3月间该机构共完成了22项体外诊断试剂临床试验的结题质控,发现涉及知情同意、临床试验合规性及管理、研究者资质培训管理、临床试验用样本的管理、试验用体外诊断试剂的管理、临床试验数据管理及临床试验报告7个方面共229项.结论 通过回顾性分析,总结出体外诊断试剂临床试验质量问题和原因,制定体外诊断试剂临床试验质量保证措施,从源头上确保体外诊断试剂临床试验质量.
Abstract
Objective To analyze the quality control issues found in the running of in-vitro diag-nostic reagents clinical trials at a medical institution,provide references for the specification of clinical trials of in-vitro diagnostic reagents in other institutions.Methods By reviewing the issues found in quality control,based on the key points of in-vitro diagnostic reagent clinical trial site inspection,we aim to summarize and analyze the reasons for these problems in the report.Results Between May 2022 and March 2023,we com-pleted 22 clinical trials for in-vitro diagnostic reagents.A total of 229 issues were identified,including prob-lems with informed consent,compliance and management of clinical trial,qualification management of investi-gators,sample management for clinical trails,management of in-vitro diagnostic reagents,data management for clinical trails,and preparation of clinical trial reports.Conclusion Through retrospective analysis,the quality issues and underlying causes of clinical trials for in-vitro diagnostic reagents were identified.As a re-sult,quality assurance measures for clinical trials were developed to ensure high standards from the beginning.
NETL
NSTL
万方数据