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Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
Session Chair(s)
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 : Describe the ongoing efforts at FDA, industry, and academia leveraging electronic health records (EHRs) in clinical investigations.
Speaker(s)
Aman Thukral, MPHARM, MS
Head of Digital Operations & Clinical Systems Data and Statistical Science (DSS), AbbVie, Inc., United States
Utilizing EHR Data: How to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites, and Sponsors
Michael A. Ibara, PHARMD
Chief Data Officer, Elligo Health Research, United States
eSource, Interoperability, and the Problem of 'Second Order Heterogeneity' in Clinical Research: A Real-World Implementation
Adam L Asare, PHD
Chief Data Officer , Quantum Leap Healthcare Collaborative, United States
Structured Sourcing of EHR Data for Process and Quality Improvements in the I-SPY 2 Trial
Jean-Francois Ethier
Prof. Agrege, Service de medicine interne, Universite de Sherbrooke, Canada
Panelist
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