Retrospective analysis of quality control issues in clinical trails of in-vitro diagnostic re-agents in a medical institution
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.
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