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Monday, June 27 • 8:30am - 9:45am
#109: EHR in Clinical Research: Heralding a New Era

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will focus on the work completed by the CDISC EHR-to-CDASH (E2C) team mapping data from EHR into EDC as eSource. Ongoing studies will be profiled. Representatives from a sponsor, academia, and EDC vendor will present.

Learning Objectives

Identify the components of EHR systems; Discuss complexities associated with EHR to EDC data transfer; Describe data standards and proper mapping between systems; Describe regulatory implications; Discuss how this will be able to help clinical research sites.


Trisha D Simpson


EHR to EDC Data Transfer: Experiences and Lessons
Ian Sparks

The eSource Stakeholders Group and Next Steps
Michael A. Ibara, PharmD

EHR-EDC Integration Case Study: The Good, the Bad, and the Beautiful
Sue Dubman, MA

avatar for Trisha Simpson

Trisha Simpson

Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval pilot project. In addition to her duties at UCB, Trisha is also very active with CDISC and TransCelerate (co-chair of CDASH, member of the CAC, CDISC TLC... Read More →

avatar for Sue Dubman

Sue Dubman

Director, IT and Informatics Innovation, University of California San Francisco (UCSF)
20+ yrs. experience. Sr. Dir, IT Innovation, at UCSF. Part of a multi-disciplinary team to innovate changes in care & research. Previously Sue was Sr. Dir, Genzyme, strategy, standards and arch. Before that, served as Dir, NCI Informatics Initiatives & VP/CIO at 2 biopharmas. At NCI, part of the original team that formed caBIG, a very large experiment in global data sharing. CDISC BOD for 6 yrs & Chair of CAC. Very active in Parkinson’s... Read More →
avatar for Michael Ibara

Michael Ibara

Head of Digital Healthcare, CDISC
Dr. Ibara is Head of Digital Healthcare for CDISC where his current work includes overseeing CDISC's participation in the FDA eSource project. He has over 20 years experience at the intersection of technology and healthcare. Previously he lead groups in pharmacovigilance and in business development coordination at Pfizer, where he created and lead the ASTER project was the first time adverse events were retrieved directly from an electronic... Read More →
avatar for Ian Sparks

Ian Sparks

Senior Director, Research Science, Medidata Solutions Worldwide
Ian Sparks is a Senior Director in Medidata Labs, an innovation group focused on evaluating new technologies and data integrations. Ian's recent work has been in integrating wearable sensors and Electronic Health Records with EDC using CDISC and HL7 standards. Ian holds a bachelors degree in Computing and has more than 20 years experience in the eClinical industry.

Monday June 27, 2016 8:30am - 9:45am
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA