Information Systems for Clinical Research

描述（由申请人提供）： 这个项目的目标是准备一本新书的长度出版物的设计，实施，维护和使用的信息系统在临床研究。到目前为止，文献中还没有这样的资源。虽然有许多关于数据库设计的书籍和其他材料，但没有一本能满足临床研究中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，但这些都没有解决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，或者他们聘请信息系统专业人员来实施系统以支持他们的研究，通常没有监督和评估他们的工作所需的知识。本出版物将填补临床研究领域存在的一个关键和长期的空白，为研究人员，项目经理，研究助理和信息系统工作人员和主管提供建立系统所需的知识和技能，以支持研究企业。建议制作一份附有光盘的硬拷贝手册。而不是一本教科书，本出版物旨在成为一个参考，将在整个研究项目的生命周期中使用。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，包括各种类型的观察性，病例对照和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不成功的信息系统实施的例子。手册将包括自我评分练习，供用户检查他们对关键概念的理解。此外，还将编制该手册的电子版，作为印刷版的配套。 将通过重点小组和调查的方式进行实质性的形成性研究，以开发电子版的界面。电子版一旦开发完成，将在一个独立的光盘上出版，以支持定义的超链接文本、交叉引用的概念和基于计算机的教程传统中的自动自我评分练习。电子版中的材料将包括手册中的材料以及补充材料，如补充参考资料。该材料将定期更新，并在订阅后提供给用户。

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.