The conduct of clinical research is critical to the advancement of health care delivery. Clinical research studies provide the basis for generating high quality and empirically grounded evidence that can be used at the patient and population levels. The design and conduct of contemporary clinical research studies is data, information, and knowledge intensive, requiring the collection, management, integration, analysis, and dissemination of diverse and multi-scale data types. Further, the information needs associated with the design and conduct of clinical studies are impacted by ethical, legal, privacy, and reporting requirements, thus amplifying the complexity of such endeavors. In this chapter, we review the basic principles of clinical study design, the role of various information systems in terms of supporting those designs, and the impact of syntactic and semantic standards in regard to enabling reproducible and rigorous data management and analyses. We will then conclude with an assessment of the current and future state of the field of Clinical Research Informatics (CRI) and open research and development questions therein.

Original languageEnglish
Title of host publicationBiomedical Informatics
Subtitle of host publicationComputer Applications in Health Care and Biomedicine: Fifth Edition
PublisherSpringer International Publishing
Number of pages28
ISBN (Electronic)9783030587215
ISBN (Print)9783030587208
StatePublished - Jul 2 2021


  • Clinical research
  • Clinical trials
  • Data analytics
  • Databases
  • Standards
  • Translational research


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