Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, Tennessee 37203, USA.
Acad Med. 2010 Jan;85(1):164-8. doi: 10.1097/ACM.0b013e3181c481bf.
The regulatory review and approval process is a significant part of the workflow associated with initiating clinical and translational research projects. Ambiguity concerning submission requirements and expected times associated with the review process can create additional work for research teams and ultimately delay important scientific projects. In an effort to provide assistance to investigators, we have developed an online interactive interface which elicits basic study characteristics for a single project and subsequently produces a list of required administrative applications needed for approval along with clear instructions concerning expectations from the research team. This system, the Vanderbilt Customized Action Plan (V-CAP), was launched in October 2006 and has been well received by researchers. In this article, the authors present (1) the V-CAP project design, (2) a reference workflow associated with Vanderbilt policies and regulations, (3) the V-CAP metrics of use by Vanderbilt research teams, and (4) a list of recommendations for other academic centers considering a similar systems-based approach for helping researchers efficiently navigate processes related to regulatory approval. The informatics-systems-based approach of the V-CAP is scalable to other academic medical centers and may serve as a useful model to help researchers navigate the complexity of the regulatory approvals process.
监管审查和审批流程是启动临床和转化研究项目相关工作流程的重要组成部分。提交要求和审查流程预期时间的不明确可能会给研究团队增加额外的工作，并最终延迟重要的科学项目。为了帮助研究人员，我们开发了一个在线交互界面，该界面可以为单个项目引出基本的研究特征，并随后生成一份批准所需的行政申请清单，并附有关于研究团队期望的明确说明。这个系统，范德比尔特定制行动计划（V-CAP），于 2006 年 10 月推出，受到了研究人员的好评。在本文中，作者介绍了（1）V-CAP 项目设计，（2）与范德比尔特政策和规定相关的参考工作流程，（3）V-CAP 被范德比尔特研究团队使用的指标，以及（4）对其他考虑采用类似基于系统的方法来帮助研究人员高效地处理与监管批准相关流程的学术中心的建议列表。V-CAP 的基于信息学系统的方法可扩展到其他学术医疗中心，并可能成为帮助研究人员应对监管批准过程复杂性的有用模型。
