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Home >> Publications >> An XML model of an enhanced data dictionary to facilitate the exchange of pre-existing clinical research data in international studies.

Publication

Author(s):

Duda SN, Cushman C, Masys DR.

Pub Title:

An XML model of an enhanced data dictionary to facilitate the exchange of pre-existing clinical research data in international studies.

Pub Date:

Dec 31 2007

Journal Issue:

Pt 1

Page Number:
449-53

Journal:

Title: 
Studies in Health Technology and Informatics
Link: 
http://ebooks.iospress.nl/publication/11015

PubMed: 17911757
Pub PDF:

Abstract
Pre-existing clinical research data sets exchanged in international epidemiology research often lack the elements needed to assess their suitability for use in multi-region meta-analyses or other clinical studies. While the missing information is generally known to local investigators, it is not contained in the files exchanged between sites. Instead, such content must be solicited by the study coordinating center though a series of lengthy phone and electronic communications: an informal process whose reproducibility and accuracy decays over time. This report describes a set of supplemental information needed to assess whether clinical research data from diverse research sites are truly comparable, and what metadata ("data about the data") should be preserved when a data set is archived for future use. We propose a structured Extensible Markup Language (XML) model that captures this information. The authors hope this model will be a first step towards preserving the metadata associated with clinical research data sets, thereby improving the quality of international data exchange, data archiving, and merged-data research using data collected in many different countries, languages and care settings.

PMID:17911757 [PubMed - indexed for MEDLINE]

PMCID: PMC3730279

 
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Citation:

Duda SN, Cushman C, Masys DR. An XML model of an enhanced data dictionary to facilitate the exchange of pre-existing clinical research data in international studies. Stud Health Technol Inform. 2007;129(Pt 1):449-53. PubMed PMID: 17911757; PubMed Central PMCID: PMC3730279.