Re-Engineering the Clinical Research Enterprise

我们计划在我们现有的网络中实施几个工具和程序，以便在调查“网络”内和为调查“网络”创造业务效率。我们将与杜克大学医学中心以外的其他网络共享这些过程和工具。我们的具体目标包括以下四个目标： 目标1：实施以建立站点能力为重点的计划和工具，最终目标是提高临床研究站点的招募、保留和绩效。 目的2：通过与临床数据交换标准联盟(CDISC)建立新的合作伙伴关系，开发一个模型来建立心血管疾病和抑郁症的通用数据元素和受控术语。 目标3：创建和实施提案开发系统，以最有效的方式征求和带来研究问题的最佳想法，从最初的概念到执行，包括适合政府、基金会或行业资助的准备工作，重点是鼓励公共/私人伙伴关系。 目标4：建立一个可在多个网络上应用和使用的网络信息学基础设施，并提供一个工具和方案的综合电子储存库，以协助网站进行研究和开展活动，同时促进网站和网络之间的交流。

We plan to implement several tools and processes in our existing networks that will create operational efficiencies within and for investigative "networks". We will share these processes and tools with other networks outside of Duke University Medical Center. Our specific objectives include the following four aims: Aim 1: Implement programs and tools focused of building site capability with the ultimate goal of enhancing the recruitment, retention, and performance of clinical research sites. Aim 2: Develop a model for establishing common data elements and controlled terminology for cardiovascular disease and depression through a new partnership with the clinical data interchange standards consortium (CDISC). Aim 3: Create and implement a proposal development system to solicit and bring the best ideas for research questions from initial concept to execution in the most efficient fashion, including preparation suitable for government, foundation, or industry funding, with a focus on encouraging public/private partnerships. Aim 4: Develop a network informatics infrastructure that can be applied and used across multiple networks and provide an integrated electronic repository of tools and programs to assist the site in its study conduct activities while fostering communication across sites and networks.