Clinical Research Informatics

Document Type

Book Chapter

Publication Date

2026

Keywords

Clinical Research, Health informatics, Study protocols, Trials, Patient recruitment

Digital Object Identifier (DOI)

https://doi.org/10.1007/978-3-032-16657-9_14

Abstract

Clinical research involves many levels of complex activities and processes needed to conduct safe and ethical research involving human subjects. It is by nature information-intensive and thereby can be enhanced with informatics support, which has led to the emergence of the subdomain of Clinical Research Informatics (CRI). CRI has developed within the broader discipline of biomedical informatics as a focus area that applies informatics technologies and principles to the implementation of study protocols, data capture, documentation and management of research data, reporting and analysis, and regulatory compliance. In this chapter, we briefly discuss foundational aspects of CRI to give readers a sense of its scope and focus areas. We briefly cover clinical research basics, core functions of clinical research management systems, diverse sources, and services that provide for the storage and retrieval of clinical research information and emphasize the need for standards in this domain. We present the topics to promote a basic level of understanding that can be used as a starting point for further investigation.

Citation / Publisher Attribution

Clinical Research Informatics, in C. Eldredge, S. S. Feldman, M. A. Faysel & A. M. Rana (Eds.), Introductory Textbook in Health Informatics, Springer Nature, p. 143-153

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