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Tuesday, June 26 • 2:00pm - 3:00pm
#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Electronic health records (EHRs) are a valuable tool for clinical research and can serve as the source of information in clinical trials. EHR data can be used for protocol design and feasibility, patient recruitment, identification of sites and investigators, monitoring adverse drug events, patient outcomes improvement and other aspects of clinical research. However, EHRs are designed to meet healthcare needs.In order to use EHRs for clinical research, there is a need to develop guidances, enhance existing data standards and conduct projects. This session will focus on the ongoing projects led by various stakeholders (FDA, biopharmaceuticals, electronic health records and electronic data capture vendors, academic medical centers, and standards development organization). This session will discuss the current state of the guidance developed by FDA focusing on the "Use of Electronic Health Record Data in Clinical Investigations".

Learning Objectives

Describe the ongoing efforts at FDA, industry, and academia leveraging electronic health records (EHRs) in clinical investigations.


Mitra Rocca, MSc


Utilizing EHR Data: How to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites, and Sponsors
Aman Thukral

eSource, Interoperability, and the Problem of 'Second Order Heterogeneity' in Clinical Research: A Real-World Implementation
Michael A. Ibara, PharmD

Structured Sourcing of EHR Data for Process and Quality Improvements in the I-SPY 2 Trial
Adam L Asare, PhD

Jean-Francois Ethier

avatar for Adam Asare

Adam Asare

Chief Data Officer, Quantum Leap Healthcare Collaborative, United States
Adam Asare has over 15 years’ experience in academic and industry developing clinical and research information systems. He has a joint appointment as Chief Data Officer at Quantum Leap Healthcare Collaborative and Director of Information Technology for the UCSF Breast Care Clinic... Read More →

Jean-Francois Ethier

Prof. Agrege, Service de medicine interne, Universite de Sherbrooke
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 Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
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 Aman Thukral

Aman Thukral

Director, Global Head-Digital Operations and Clinical Systems, AbbVie, Inc., United States
Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading clinical systems such as EDC, IRT, ePRO, CDR, Medical Coding. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie... Read More →

Tuesday June 26, 2018 2:00pm - 3:00pm EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Session