新版GCP下临床试验研究信息化建设思路探讨

Discussion on the construction of clinical trial research informatization under the New GCP

目的:我国在临床试验研究信息化建设上仍处于探索与发展阶段,通过分析临床试验研究金标准,为信息化建设提供指导和参考。方法:以新版《药物临床试验质量管理规范》(good clinical practice,GCP)为研究对象,借鉴二维象限法和内容分析法对信息化内容进行分类分析。结果:构建二维四象限框架,将信息化内容划分为4类,针对不同类别给出对应信息化建设思路。结论:新版GCP为信息化建设提供了契机,利用电子化手段重塑临床试验业务流程、利用智能化手段辅助全程质量控制、利用远程技术提升监查监管效率等,有助于提升医院临床研究整体水平,助力向高质量研究型医院转型。

Objective Provide construction ideas for clinical trial research informatization by analyzing the gold standard of clinical research.Methods Take the new version of good clinical practice(GCP)as the research object and use two-dimensional quadrant method and content analysis method for classification analysis.Results This paper constructs a two-dimensional four quadrant classification diagram,divides and defines the information content into four categories,and gives the corresponding information construction countermeasures for different categories.Conclusion The new version of GCP provides an opportunity for information construction,such as reshaping the clinical trial business process by electronic means,assisting the whole process quality control by intelligent means,and improving the efficiency of supervision by remote technology.Seizing the opportunity will help to improve the overall level of hospital clinical research and help to transform to a high-quality research hospital.