We know it is really October, but we held the posting of this edition until we could point you to the full scientific article on DCT Data Management located on Covance.com. We hope you will find it to be worth the wait!
Welcome to the September edition of the Covance DCT Blog.
上个月，我们探讨了由于Covid-19大流行而探索了现场访问替代服务的需求，例如移动校友和移动护理。在前所未有的时间内保持对轨道的访问，是他们在现场或偏远的情况下对审判成功至关重要。
But once the visits happen, are there any special data management considerations, once trials shift to a more decentralized methodology? This month, we will take a quick look at this, and invite you to download a recently published article that digs into more detail on this topic.
Clinical trial data management systems have been evolving since the first clinical trials began in the 1940s. The architecture of data management has for the most respect grown to match the needs of the clinical trial design. As trials have become more complex, so too have the means by which we collect, store, and analyze clinical trial data. The shift to more remote visits, and new types of data such as from wearable sensors, will cause the data management needs to shift accordingly. Traditional trials don’t use a “one size fits all” data management approach, and neither will DCTs.
正如DCT所涉及的模块化解决方案的生态系统，如患者应用，样品收集，药物供应，远程访问等，那么DCT的数据管理架构是可以反应的柔性部件的生态系统的数据管理架构变得越来越重要。适当地达到现代化临床试验使用的数据来源的多样化。重要的是，ECRFS（电子案例报告表格）在主题水平中产生整体临床观点，以允许调查人有效审查数据并批准它们。
在DCT数据管理涉及的另一个挑战the greater range of devices and applications involved. A typical DCT will have the patients supplied with a provisioned device (a tablet or a smartphone) which is dedicated to the trial, or allow them to use personal smart devices or computers aka “bring your own device” or BYOD which increases the complexity of the environment in which trial apps and data collection will occur. This added complexity needs to be reviewed in the context of the regulatory environments in which the trial will occur. This adds a validation effort layer, which largely replaces the data transcription review that happens when data sources are not integrated directly.
These hot button issues only scratch the surface of all the considerations that need to be taken into account as we transition more and more trials to DCT models. For a complete review of these and many other factors around technology integration, quality and regulatory compliance, and vendor management, please download our article“Clinical Data Management Considerations for Decentralized Trial (DCT) Execution“。
下个月回顾我们，当我们深入挖掘由临床试验设计驱动的系统集成问题时。
要了解更多关于Covance如何帮助您建立分散的临床试验的效率，请访问covance.com.。
You can also find additional DCT resources like case studies, white papers, scientific articles and more atwww.wfliji.com/dct教育。
