Article

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

Department of Pediatrics, University of South Florida College of Medicine, Tampa, Florida, USA.
Journal of the American Medical Informatics Association (impact factor: 3.61). 05/2011; 18(3):341-6. DOI:10.1136/amiajnl-2011-000107 pp.341-6
Source: PubMed

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.

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    Article: Clinical research informatics: a conceptual perspective.
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    ABSTRACT: Clinical research informatics is the rapidly evolving sub-discipline within biomedical informatics that focuses on developing new informatics theories, tools, and solutions to accelerate the full translational continuum: basic research to clinical trials (T1), clinical trials to academic health center practice (T2), diffusion and implementation to community practice (T3), and 'real world' outcomes (T4). We present a conceptual model based on an informatics-enabled clinical research workflow, integration across heterogeneous data sources, and core informatics tools and platforms. We use this conceptual model to highlight 18 new articles in the JAMIA special issue on clinical research informatics.
    Journal of the American Medical Informatics Association 04/2012; 19(e1):e36-e42. · 3.61 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.

Keywords

bridging generic structural standards
 
Case report forms
 
clinical research
 
clinical research applications
 
Clinical research informatics
 
clinical research studies
 
content standards
 
CRF content
 
current limitations
 
define tools requirements
 
domain-specific content standards
 
Future standards adoption
 
research activities
 
research data collection
 
standards adoption
 
standards efforts
 
support retrieval
 
terminological standards
 
varied clinical research stakeholders
 
workflow support