Information Systems for Clinical Research

临床研究信息系统

• 批准号: 6760546
• 负责人: JOHN H. HOLMES
• 金额: $ 7.88万
• 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 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6760546
• 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）： 该项目的这个目标是准备有关临床研究中信息系统的设计，实施，维护和使用的新的书籍长度出版物。迄今为止，文献中还没有这种资源。尽管有许多数据库设计上的书籍和其他材料可用，但没有人能满足从事临床研究的各种专业人员的需求。相反，有许多有关临床研究的书籍和其他资源的例子，但是这些都没有解决数据库和其他信息系统专业人员的需求。结果，即使没有这样做的专业知识，临床研究人员也被迫创建自己的数据库，或者他们雇用了信息系统专业人员来实施系统来支持他们的研究，通常没有监督和评估其工作所需的知识。该出版物将填补临床研究领域中存在的关键且长期存在的差距，从而为研究人员，项目经理，研究助理以及信息系统人员和主管提供建立支持研究企业所需的知识和技能。提出了一本带有CD的硬拷贝手册。该出版物不是教科书，而是旨在在整个研究项目生命周期中使用的参考。因此，它将包括有关数据库理论的实用信息，特别是因为它应用于一系列研究设计，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处理，并将包括许多成功和失败的信息系统实现的示例。自我分级练习将包含在手册中，供用户检查他们对关键概念的理解。此外，该手册的电子版本将作为硬拷贝版本的伴侣开发。 通过焦点小组和调查的方式，实质性的形成性研究将用于开发电子版本的界面。一旦开发，电子版将发布在独立的CD上，以支持针对基于计算机的教程传统的定义，交叉引用概念以及自动化的自我分级练习的超链接文本。电子版本涵盖的材料将包括手册中的材料以及补充材料，例如其他参考文献。该材料将定期更新，并在订阅后向用户提供。