Information Systems for Clinical Research

临床研究信息系统

• 批准号: 6896860
• 负责人: JOHN H. HOLMES
• 金额: $ 7.93万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6896860
• 关键词: DVD /CD ROM; clinical research; information systems; library; publications

DESCRIPTION (provided by applicant): This goal of this project is to prepare a new book-length publication on the design, implementation, maintenance, and use of information systems in clinical research. To date, no such resource exists in the literature. While many books and other materials on database design are available, none addresses the needs of a variety of professionals working in clinical research. Conversely, there are many examples of books and other resources on clinical research, yet none of these addresses the needs of database and other information systems professionals. As a result, clinical researchers have been forced to create their own databases, even without the specialized knowledge required to do so, or they have hired information system professionals to implement systems to support their research, often without the knowledge needed to supervise and evaluate their work. This publication will fill a critical and longstanding gap that exists in the domain of clinical research, providing investigators, project managers, research assistants, and information systems staff and supervisors with the knowledge and skills needed to build systems to support the research enterprise. A hard-copy handbook with accompanying CD is proposed. Rather than a textbook, this publication is intended to be a reference that would be used throughout the research project life cycle. As such, it will include practical information about database theory, particularly as it is applied to a range of research designs, including observational, case-control, and cohort studies of various types, as well as randomized controlled trials. Each of these designs will be treated in separate chapters, and will include numerous examples of successful and unsuccessful information system implementations. Self-graded exercises will be included in the handbook for users to check their understanding of key concepts. In addition, an electronic version of the handbook will be developed as a companion to the hard-copy version. Substantial formative research, by way of focus groups and surveys, will be used to develop the interface for the electronic version. Once developed, the electronic version will be published on a self-contained CD to support hyperlinked text for definitions, cross-referenced concepts, and automated self-graded exercises in the computer-based tutorial tradition. The material covered in the electronic version will include material from the handbook as well as supplemental material such as additional references. This material will be updated periodically and made available to users upon subscription.

描述（由申请人提供）： 该项目的目标是编写一本关于临床研究中信息系统的设计、实施、维护和使用的新书本出版物。迄今为止，文献中尚不存在此类资源。尽管有许多关于数据库设计的书籍和其他材料，但没有一个能够满足从事临床研究的各种专业人员的需求。相反，有许多关于临床研究的书籍和其他资源的例子，但这些都没有满足数据库和其他信息系统专业人员的需求。因此，临床研究人员被迫创建自己的数据库，即使没有这样做所需的专业知识，或者他们聘请了信息系统专业人员来实施系统来支持他们的研究，而通常没有监督和评估他们的研究所需的知识。工作。该出版物将填补临床研究领域存在的一个关键且长期的空白，为研究人员、项目经理、研究助理以及信息系统工作人员和主管提供构建支持研究事业的系统所需的知识和技能。建议提供硬拷贝手册和随附​​的 CD。该出版物不是一本教科书，而是作为整个研究项目生命周期中使用的参考资料。因此，它将包括有关数据库理论的实用信息，特别是当它应用于一系列研究设计时，包括观察性、病例对照和各种类型的队列研究以及随机对照试验。这些设计中的每一个都将在单独的章节中进行讨论，并将包括大量成功和不成功的信息系统实施的例子。手册中将包含自评分练习，供用户检查他们对关键概念的理解。此外，还将开发该手册的电子版，作为纸质版的配套手册。 将通过焦点小组和调查进行大量形成性研究来开发电子版本的界面。一旦开发完成，电子版本将在独立的 CD 上发布，以支持基于计算机的教程传统中的定义、交叉引用概念和自动自评分练习的超链接文本。电子版中涵盖的材料将包括手册中的材料以及补充材料，例如其他参考资料。该材料将定期更新，并在订阅后提供给用户。