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.
