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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Richesson, RL; Nadkarni, P

Published Date

  • May 2011

Published In

Volume / Issue

  • 18 / 3

Start / End Page

  • 341 - 346

PubMed ID

  • 21486890

Pubmed Central ID

  • 21486890

Electronic International Standard Serial Number (EISSN)

  • 1527-974X

International Standard Serial Number (ISSN)

  • 1067-5027

Digital Object Identifier (DOI)

  • 10.1136/amiajnl-2011-000107

Language

  • eng