We define Clinical Research Informatics (CRI) as the sub-domain of biomedical informatics concerned with the development, use and evaluation of standards, models, processes and systems to optimize the design and conduct of clinical and translational research* and disseminate the knowledge generated.

Examples of CRI focus areas include:

• Evaluation and modeling of clinical and translational research workflow
• Social and behavioral studies involving clinical research professional and participants
• Designing optimal human-computer interaction models for clinical research applications
• Improving information capture and data flow in clinical research
• Optimizing site selection, investigator and subject recruitment
• Development and evaluation of standardized approaches to research data management and dissemination
• Enhancing clinical and research data mining, integration, and analysis
• Integrating research findings into individual and population level health care
• Defining and promoting ethical standards in CRI practice
• Educating researchers, informaticians, and organizational leaders about CRI
• Driving public policy around clinical and translational research informatics

Clinical Research comprises studies and trials in human subjects that fall into the three sub-categories:

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
2. Epidemiologic and behavioral studies.
3. Outcomes research and health services research.