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Electronic Source Data in Clinical Investigations (Part 2 of 2): Practical Implementation

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
238

Room Number:
30CD

Level:
Intermediate

Type:
Forum

Title:
Electronic Source Data in Clinical Investigations (Part 2 of 2): Practical Implementation

Chair(s):
Linda King, MT
Director, Global Data Delivery
Eli Lilly and Company, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Electronic Source Data: Clinician's Perspective
Drew W. Rasco, MD
Clinical Investigator
South Texas Accelerated Research Therapeutics (START), United States

Sponsor-Provided eSource Solutions and Challenges to Implementation
Andrew Roberts, MS
Clinical Business Strategy Expert
Novartis Institutes for BioMedical Research, Switzerland

EHRs for Clinical Research: Pivotal Progress Toward Global Data Standards
Bron Witt Kisler
Vice President, Strategic Initiatives
CDISC, United States

Direct Transmission of Data from the EHR to the eCRF: Insights from a Real-World Implementation
Jane Griffin, RPh
Director, Cerner Research
Cerner Corporation, United States