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Session Chair(s)
Ron Fitzmartin, PHD, MBA
Principal Consultant
Decision Analytics, United States
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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