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Electronic Source Data in Clinical Investigations (Part 2 of 2): Practical Implementation
Session Chair(s)
Linda King, MT
Director, Global Data Delivery, Eli Lilly and Company, United States
This two-part forum's FDA-industry panel will focus on the regulatory and practical considerations with respect to the FDA Guidance on Electronic Source Data in Clinical Investigations (eSource).
Part 1 will take place on Tuesday at 8:00 am (Session #210).
Learning Objective : Describe eSource guidance in clinical trials; Discuss the eSource guidance including its regulatory impact on electronic data capture (EDC) and electronic health records (EHRs); Identify practical considerations from industry in implementing eSource clinical trials.
Speaker(s)
Drew W. Rasco, MD
Clinical Investigator, South Texas Accelerated Research Therapeutics (START), United States
Electronic Source Data: Clinician's Perspective
Andrew Roberts, MS
Clinical Business Strategy Expert, Novartis Institutes for BioMedical Research, Switzerland
Sponsor-Provided eSource Solutions and Challenges to Implementation
Bron Kisler
Senior Vice President Customer Alliances and Partnerships, Nurocor, United States
EHRs for Clinical Research: Pivotal Progress Toward Global Data Standards
Jane Griffin, RPH
Director, Cerner Research, Cerner Corporation, United States
Direct Transmission of Data from the EHR to the eCRF: Insights from a Real-World Implementation
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