Format

Send to

Choose Destination
See comment in PubMed Commons below
J Am Med Inform Assoc. 2011 May 1;18(3):341-6. doi: 10.1136/amiajnl-2011-000107.

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

Author information

1
Department of Pediatrics, University of South Florida College of Medicine, Tampa, Florida, USA.

Abstract

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.

PMID:
21486890
PMCID:
PMC3078665
DOI:
10.1136/amiajnl-2011-000107
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Silverchair Information Systems Icon for PubMed Central
    Loading ...
    Support Center