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Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations
Session Chair(s)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, 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)
Mitra Rocca, MSC
Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Electronic Source Data in Clinical Investigations
Sean Kassim, PHD
Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA, United States
Panelist
Leonard Sacks, MD
Director, Clinical Methodologies,Office of Medical Policy, CDER, FDA, United States
Panelist
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