Adverse Event Reporting using FDA Form 3500A

Ofni Clinical automates generation of MedWatch FDA Form 3500A

MedWatch is the FDA reporting system for Adverse Events (AEs), and Form 3500A is used for Adverse Event reporting. The Adverse Event reporting system in Ofni Clinical makes generation of FDA MedWatch 3500A forms quick and easy. Forms can then be exported to paper or electronic formats.

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 then generates the MedWatch Form 3500A. You can also designate existing data entry fields from the case report forms to be used in the creation of the 3500A form.



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