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Clinical research informatics: Policies and standards supporting data integration in multi-site clinical trials and data re-use within large research warehouses

Thursday, November 07, 2013 — Poster Session II

12:00 p.m. – 2:00 p.m.

FAES Academic Center (Upper-Level Terrace)




  • V. Huser
  • X. Pan
  • J.J. Cimino


The field of clinical research informatics (CRI) tries to facilitate research by providing intelligent clinical trial management systems (CTMSs) and increase the research utility of electronic health record (EHR) systems used in routine health care. A significant CRI challenge is integration of data from multiple sites that use different CTMS systems. Research integrated data repositories (IDRs) enable investigators to streamline retrieval of individual trial data as well as re-use data from prior trials. At NIH, the Biomedical Translational Research Information System (BTRIS), integrates data from CTMSs of individual institutes and the local EHR. We assessed the suitability of existing data exchange standards for clinical or research data to serve as data transport format for import into the IDR. The following standards were evaluated: CDISC Operational Data Model (ODM), CDISC Study Data Tabulation Model, W3C XForms, and i2b2 observation fact format. We also looked at which formats are supported by the CTMSs used by various institutes. Preliminary results show that the ODM standard can represent very complex data structures and has been adopted by most CTMSs. The poster will include examples of different representations of clinical trial electronic Case Report Forms (eCRF) data that demonstrate several research enterprise data integration challenges.

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