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Siebel Life Sciences Guide > Regulatory Reporting >
Which Sections of the MedWatch 3500A Form Get Filled In?
Not all sections of the MedWatch 3500A get filled in for every report. Which sections are filled in depends upon the Event Type and Facility Type fields. These sections always get filled in:
- A. Patient Information
- B. Adverse Event or Product Problem
- E. Initial Reporter
Table 46 lists the conditions for which the other sections get filled in.
Table 46. Sections of the Report Filled In According to Event Type and Facility Type Field Values
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These sections are filled in... |
And these sections are left blank... |
Event Type =
Adverse Event Drug,
Product Problem Drug, or
AE and PP Drug |
— |
C G |
D F H |
Event Type 1 =
Adverse Event Device,
Product Problem Device,
or
AE and PP Device |
Facility Type = NULL (blank) |
D G H |
C F |
Facility Type 2 =
User Facility, Distributor, or Importer
(That is, not blank) |
D F G |
C H |
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