J Am Med Inform Assoc 18:341-346 doi:10.1136/amiajnl-2011-000107
  • Perspective

Data standards for clinical research data collection forms: current status and challenges

  1. Prakash Nadkarni2
  1. 1Department of Pediatrics, University of South Florida College of Medicine, Tampa, Florida, USA
  2. 2Yale University, New Haven, Connecticut, USA
  1. Correspondence to Dr Rachel L Richesson, University of South Florida College of Medicine, Department of Pediatrics, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USA; richesrl{at}
  • Received 5 November 2008
  • Accepted 8 February 2011


Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.


  • Funding Funding and/or programmatic support for this project was provided by Grant Numbers RR019259-01 and RR019259-02 from the National Center for Research Resources and National Institute of Neurological Disorders and Stroke, respectively, both National Institutes of Health components, and the National Institutes of Health Office of Rare Diseases Research.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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