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Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
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 : 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.
Speaker(s)
Electronic Source Data in Clinical Investigations
Mitra Rocca, MSc
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
Panelist
Sean Kassim, PhD
FDA, United States
Director, Office of Study Integrity and Surveillance, OTS, CDER
Panelist
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
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