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Home > Products > Ofni Clinical > Serious Adverse Event Reporting
Automatic Generation of FDA Form 3500A
Ofni Clinical automatically generates Medwatch FDA Form 3500A
MedWatch is the FDA's reporting system for Serious Adverse Events. Form FDA 3500A is used for serious adverse event reporting. The Adverse Event reporting system in Ofni Clinical automates the generation of the FDA MedWatch Form 3500A by creating electronic (PDF) copies for submission.
Serious Adverse Events Reports
Users enter the adverse event report data, including patient information, a description of the adverse event and the suspect product or device. Ofni Clinical generates the Medwatch Form 3500A. You can also designate any existing data entry field from existing case report forms to be used in the creation of the 3500A form.
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