About Report Types

The following table details the four regulatory reports that can be created in Siebel AECM.

Report Type	Use	Data for the Report Is Taken from These Views in the Regulatory Reports Screen
3500A	For initial mandatory reports to MedWatch (FDA).	More Info Patient Importer (if the Facility Type field in the Importer view is not blank) Manufacturer and Investigation (if the Facility Type field in the Importer view is blank)
3500A Supplemental	For additional information to MedWatch after initial reports have been submitted.	More Info Patient Importer (if the Facility Type field in the Importer view is not blank) Manufacturer and Investigation (if the Facility Type field in the Importer view is blank)
MDV Initial	For initial reports to NCAs who accept MDV forms.	More Info Patient MDV
MDV Follow-up	For additional information to NCAs after initial reports have been submitted.	More Info Patient MDV