Automated Development of Electronic Data Capture for Clinical Trials

临床试验电子数据采集的自动化开发

• 批准号: 7626976
• 负责人: Mansur R. Kabuka
• 金额: $ 42.42万
• 依托单位: INFOTECH SOFT, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7626976
• 关键词: Architecture; Asses; Automation; Case Report Form; Clinical; Clinical Data; Clinical Research; Clinical Trials; Computer Assisted; Computer software; Computer-Aided Design; Cost Savings; Cost-Benefit Analysis; Custom; Data; Data Collection; Data Quality; Databases; Development; Dictionary; Documentation; Drug Formulations; Electronics; Ensure; Feedback; Goals; Guidelines; Health; Hearing; Impaired cognition; Individual; Information Systems; Language; Metadata; Modeling; National Institute of Drug Abuse; Operative Surgical Procedures; Paper; Phase; Reading; Reporting; Research; Research Design; Site; Software Tools; Specific qualifier value; Structure; Substance abuse problem; System; Techniques; Technology; Testing; Time; Visual; base; computerized; cost; data format; data modeling; data sharing; design; electronic data; experience; improved; instrument; interoperability; prototype; quality assurance; research and development; response; task analysis; tool; usability; user centered design

DESCRIPTION (provided by applicant): This proposal is in response to PHS 2007-2 NIDA Topic "Automation of the Development of Electronic Data Capture System for Clinical Trials Data Collection and Management". We propose to develop the Automated Development of Electronic Data Capture (AD-EDC) System, a set of graphical tools and automated software applications that will help simplify, automate, standardize, and reduce the cost of creating and reporting the research instruments used in substance abuse clinical trials. The main objectives of the project are to develop technologies that will: (1) significantly reduce the costs and errors involved in developing electronic data capture (EDC) instruments for clinical trials; (2) significantly reduce the costs and errors involved in reporting and sharing study results; (3) interoperate with a wide-range of information systems and commercial, off-the-shelf clinical trial management systems (CTMS) and utilize Clinical Data Interchange Standards Consortium (CDISC) standards; and (4) provide non-technical, clinical users an easy to use system that includes accessibility support, which will allow users with visual, hearing, physical, and cognitive impairments to effectively participate in clinical trials. The Phase I research effort will focus on defining a high-level architecture for the AD-EDC System, refining functional specifications and user interface designs for the AD-EDC software components, defining an open format for electronic data dictionaries, and performing a cost-benefit analysis to demonstrate that, through software automation and computer-assisted design tools, the project's specific aims are feasible. The Phase II effort will focus on implementing the complete set of study design tools, study reporting tools, and system interoperability components that will be necessary to achieve the project's aims. At the end of Phase II, the AD-EDC System will be pilot tested in a diverse set of real-world clinical settings and a cost-benefit analysis will be performed to validate that the system achieves the project aims. PUBLIC HEALTH RELEVANCE: The AD-EDC System consists of set of graphical tools and automated software modules that will help simplify, automate, standardize, and reduce the cost of creating and reporting clinical research instruments used in substance abuse clinical trials. The AD-EDC System is designed to interoperate with commercial, off-the-shelf clinical trials management systems either through a standard CDISC- compliant ODM interface or through custom external system adapters. Standard data representations based on CDISC standards are used by the tools and components of the AD-EDC System to support interoperability and persistence.

描述（由申请人提供）：该建议是对PHS 2007-2 NIDA主题的回应，“用于临床试验数据收集和管理的电子数据捕获系统的开发自动化”。我们建议开发电子数据捕获（AD-EDC）系统的自动开发，这是一组图形工具和自动化软件应用程序，这些应用程序将有助于简化，自动化，标准化并降低创建和报告用于药物滥用药物滥用临床试验的研究工具的成本。该项目的主要目标是开发将：（1）大大降低开发电子数据捕获（EDC）仪器的成本和错误； （2）大大降低报告和共享研究结果所涉及的成本和错误； （3）与广泛的信息系统和商业，现成的临床试验管理系统（CTM）互操作，并利用临床数据交换标准财团（CDISC）标准； （4）为非技术用户提供一个易于使用的系统，其中包括可访问性支持，该系统将允许具有视觉，听力，身体和认知障碍的用户有效地参与临床试验。第一阶段的研究工作将重点放在定义AD-EDC系统的高级体系结构上，为AD-EDC软件组件进行完善功能规范和用户界面设计，为电子数据词典定义了开放格式，并执行成本效果分析，以证明，通过软件自动化和计算机认可的设计工具，可以证明，Project of Project的特定工具，可以证明。第二阶段的工作将着重于实施完整的研究设计工具，研究报告工具和系统互操作性组件，这是实现项目目标所必需的。在第二阶段结束时，AD-EDC系统将在各种现实世界的临床环境中进行试点测试，并将进行成本效益分析以验证该系统是否实现了该项目的目标。 公共卫生相关性：AD-EDC系统由一组图形工具和自动化软件模块组成，这些模块将有助于简化，自动化，标准化和降低创建和报告药物滥用临床试验中使用的临床研究工具的成本。 AD-EDC系统旨在通过标准的符合CDISC的ODM接口或通过自定义外部系统适配器与商业，现成的临床试验管理系统进行互操作。 AD-EDC系统的工具和组件使用基于CDISC标准的标准数据表示来支持互操作性和持久性。