Embi and Payne, Clinical Research Informatics
Clinical Research Informatics: Challenges, Opportunities and
Definition for an Emerging Domain
PETER J. EMBI, MD, MS, PHILIP R.O. PAYNE, PHD
A b s t r a c t Objectives: Clinical Research Informatics, an emerging sub-domain of Biomedical Informatics, is
currently not well defined. A formal description of CRI including major challenges and opportunities is needed to
direct progress in the field.
Design: Given the early stage of CRI knowledge and activity, we engaged in a series of qualitative studies with
key stakeholders and opinion leaders to determine the range of challenges and opportunities facing CRI. These
phases employed complimentary methods to triangulate upon our findings.
Measurements: Study phases included: 1) a group interview with key stakeholders, 2) an email follow-up survey
with a larger group of self-identified CRI professionals, and 3) validation of our results via electronic peer-
debriefing and member-checking with a group of CRI-related opinion leaders. Data were collected, transcribed,
and organized for formal, independent content analyses by experienced qualitative investigators, followed by an
iterative process to identify emergent categorizations and thematic descriptions of the data.
Results: We identified a range of challenges and opportunities facing the CRI domain. These included 13 distinct
themes spanning academic, practical, and organizational aspects of CRI. These findings also informed the
development of a formal definition of CRI and supported further representations that illustrate areas of emphasis
critical to advancing the domain.
Conclusions: CRI has emerged as a distinct discipline that faces multiple challenges and opportunities. The
findings presented summarize those challenges and opportunities and provide a framework that should help
inform next steps to advance this important new discipline.
J Am Med Inform Assoc. 2009;16:316–327. DOI 10.1197/jamia.M3005.