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

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 thei...

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Bibliographic Details
Published in:Journal of the American Medical Informatics Association : JAMIA 2011-05, Vol.18 (3), p.341-346
Main Authors: Richesson, Rachel L, Nadkarni, Prakash
Format: Article
Language:English
Subjects:
Biomedical Research - methods
Data Collection - standards
Forms and Records Control
Humans
Information Storage and Retrieval
Reference Standards
Surveys and Questionnaires
User-Computer Interface
Vocabulary, Controlled
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Summary: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.
ISSN:1067-5027
1527-974X
DOI:10.1136/amiajnl-2011-000107