INTEGRATED FORMS TECHNOLOGY FOR CLINICAL TRIALS

用于临床试验的集成技术

• 批准号: 3492909
• 负责人: Channing H Russell
• 金额: $ 4.96万
• 依托单位: BELMONT RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-01 至 1994-07-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3492909
• 关键词: case history; clinical trials; computer graphics /printing; computer human interaction; computer system design /evaluation; data collection methodology /evaluation; health care facility information system; human data; patient /disease registry; telecommunications

The goal of this research is to develop a new data collection technology for clinical trials that can reduce the effort needed to gather clinical research data and improve the timeliness and quality of the data. The technology is based on an integrated approach that uses the familiar case report form model to support more direct and efficient communication been clinical personnel (e.g., investigators, medical monitors, clinical data coordinators) and the clinical data system. Phase I research will be focused on (l) concept refinement through interaction with collaborators at academic and biotechnology industry clinical research organizations, (2) design of a new integrated software tool for clinical data definition and collection, and (3) construction and evaluation of an initial prototype. The major technical innovation is to utilize advances in computer-assisted software engineering, graphical layout, laser printing, facsimile transmission, and machine-readable identification to automate aspects of case report form management that now require many separate manual steps. The major health-related benefit is to improve the speed and accuracy of clinical trial data collection, and therefore to contribute to improving the efficacy of clinical research in evaluating new treatments for cancer, AIDS, and other diseases.

这项研究的目的是开发新的数据收集技术 对于可以减少收集临床所需努力的临床试验 研究数据并提高数据的及时性和质量。这 技术基于使用熟悉情况的集成方法 报告表格模型以支持更直接有效的沟通 临床人员（例如，调查人员，医疗监视器，临床数据 协调员）和临床数据系统。 第一阶段的研究将重点放在（L）通过 与学术和生物技术行业的合作者互动 临床研究组织，（2）新的集成软件的设计 用于临床数据定义和收集的工具，以及（3）构建和 评估初始原型。 主要的技术创新是利用计算机辅助的进步 软件工程，图形布局，激光打印，传真 传输和机器可读识别以自动化 病例报告表格管理现在需要许多单独的手动步骤。 与健康相关的主要好处是提高 临床试验数据收集，因此有助于改善 临床研究在评估癌症新疗法方面的功效， 艾滋病和其他疾病。