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End-to-End Data and Metadata in Today's Clinical Trials

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
386

Room Number:
33AB

Level:
Intermediate

Type:
Symposium

Title:
End-to-End Data and Metadata in Today's Clinical Trials

Chair(s):
Keith W. Wenzel
Senior Director, Global Alliances
PAREXEL International , United States

Description:
The sources of today's clinical trials data are ever expanding from classic electronic data capture (EDC) and electronic patient-reported outcome (ePRO) systems to progressive study endpoints data collection via physiologic devices (such physical activity monitors) to electronic health record (EHR) systems. At the same time, sponsors and CROs are desiring to leverage their substantial investments in case report form (CRF) designs across EDC system via metadata repositories. This innovative symposium will guide the audience in understanding the clinical trials equivalent of iTunes as well as provide real-world experiences from the first prospective study to utilize the CDISC standards for EHR integration.

Learning Objective(s):
Discuss how an iTunes metadata repository can be established using CDISC standardized content (CDASH and SDTM-IG) stored in a CDISC vendor neutral model (ODM/define.xml); Describe the nuances of electronic health record (EHR) integration between different sites and different EHR systems.

Presentation(s) & Speaker(s):
Achieving the iTunes of Clinical Trials: Storing and Sharing of Content to Optimize the End-to-End Clinical Trial Process
Mark L. Wheeldon, PharmD
Chief Executive Officer
Formedix, United States

The First Real-World Implementation of CDISC-based EHR Integration for a Prospective Clinical Trial
Jim Rogers
President & CEO
Nextrials, United States

Delivering Real Efficiencies for Clinical Trials Using Electronic Healthcare Data: How CPRDs are Leading the Way
Tim Williams, PhD, MSc
Head of Research
The Clinical Practice Research Datalink Group (CPRD), United Kingdom