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DIA 2018 Global Annual Meeting


Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations

    Session Chair(s)
      Mitra  Rocca, MSc

      Mitra Rocca, MSc

      • Associate Director, Medical Informatics, Office of Translational Science, CDER
      • FDA, United States
    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 Objective : Understand how eSource, interoperability, and the learning health care system all share a fundamental common problem that prevents merging and re-use of health care data; Describe the problem of 'second order heterogenity' in clinical research and health care.
    Speaker(s)
      Aman  Thukral, DrSc, MBA, MPharm

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

      Aman Thukral, DrSc, MBA, MPharm

      • Assistant Director
      • AbbVie, Inc., United States
      Michael A. Ibara, PharmD

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

      Michael A. Ibara, PharmD

      • Head of Digital Healthcare
      • Michael Ibara Consulting, United States
      Adam L Asare, PhD

      Structured Sourcing in EHRs

      Adam L Asare, PhD

      • Chief Data Officer
      • Quantum Leap Healthcare Collaborative, United States