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Which Sections of the MedWatch 3500A Form Are Filled In?

Not all sections of the MedWatch 3500A are filled in for every report. Which sections are filled in depends upon the Event Type and Facility Type fields. The Event Type field is in the More Info view of the Regulatory Reports screen. The Facility Type field is in the Importer view of the Regulatory Reports screen.

These sections always are filled in:

• A. Patient Information
• B. Adverse Event or Product Problem
• E. Initial Reporter

Table 36 lists the conditions for which the other sections get filled in.