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Food and Drug Administration / Technology / Pharmaceutical industry / pharmacology / Adverse Event Reporting System / Medical device / Clinical investigator / Regulatory requirement / Electronic patient-reported outcome / Clinical research / Medicine / Research


Computerized Systems Used in Medical Device Clinical Investigations Presented by Jonathan Helfgott Consumer Safety Officer Division of Bioresearch Monitoring Office of Compliance
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Company

Laboratory Information Management Systems / Hybrid- Electronic/Paper Systems / Computerized Systems / /

Organization

FDA / Bioresearch Monitoring Office / Compliance Center for Devices and Radiological Health Objectives / Contract Research Organization / Jonathan Helfgott Consumer Safety Officer Division / /

Person

Jonathan Helfgott / /

Position

Investigator / /

Product

Holter- Monitor / /

Technology

Interactive Voice Response System / MRI / /

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