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Wednesday, June 29 • 2:00pm - 3:15pm
#340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research

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Limited Capacity seats available

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

eSource, in the sense of capturing source data for clinical trials directly from the EHR, holds great promise for improving speed, quality and efficiency in research. FDA, CDISC, and participating organizations will describe ongoing work.

Learning Objectives

Discuss an eSource implementation and its expected effect on data quality and efficiencies; Describe current work now underway in eSource with various organizations; Evaluate the readiness of your organization to implement eSource.


Michael A. Ibara, PharmD


Academic Perspective
Amy Harris Nordo

Current FDA eSource Demonstration Projects and Overall Effort
Mitra Rocca, MSc

EHR Pilot Study: Lessons Learned Thus Far
Trisha D Simpson

avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →

avatar for Amy Nordo

Amy Nordo

Product Manager, Maestro Care (Epic) for Research and eSource, Duke University
Amy Nordo RN/BSN, CPHQ, LNC, MMCi is a Product Manager for Duke University’s Office of Research Informatics. Amy draws upon her previous experience as critical care nurse, clinical research coordinator, healthcare quality professional and Epic credentialed trainer. In her current... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →
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... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session