DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

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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)

Electronic Source Data: Clinician's Perspective

Drew W. Rasco, MD

South Texas Accelerated Research Therapeutics (START), United States

Clinical Investigator

Sponsor-Provided eSource Solutions and Challenges to Implementation

Andrew Roberts, MS

Novartis Institutes for BioMedical Research, Switzerland

Clinical Business Strategy Expert

EHRs for Clinical Research: Pivotal Progress Toward Global Data Standards

Bron Kisler

Nurocor, United States

Senior Vice President Customer Alliances and Partnerships

Direct Transmission of Data from the EHR to the eCRF: Insights from a Real-World Implementation

Jane Griffin, RPh

Cerner Corporation, United States

Director, Cerner Research

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