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Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 17, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
210

Room Number:
30CD

Level:
Intermediate

Type:
Forum

Title:
Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations

Chair(s):
Ron Fitzmartin, PhD, MBA
Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
FDA, United States

Description:
This two-part forum's panel will focus on the regulatory and practical considerations with respect to the FDA Guidance on Electronic Source Data in Clinical Investigations (eSource).

Part 2 will take place on Tuesday at 10:30 am (Session #238).

Learning Objective(s):
Describe eSource guidance in clinical trials; Discuss the eSource guidance and 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 in Clinical Investigations
Mitra Rocca, MS
Senior Medical Informatician, Office of Translational Science, CDER
FDA, United States

Panelist
Sean Y. Kassim, PhD
Acting Office Director, OSI, OC, CDER
FDA, United States

Panelist
Leonard Sacks, MD
Associate Director of Clinical Methodology, Office of Medical Policy, CDER
FDA, United States