Add FDA PSUR support information

The FDA PSUR Support section can be used if the company has obtained an FDA waiver to submit a PSUR instead of an NDA report.

Field Description

Include Adverse Event Summary

Select this option to generate a sub-report of events from the line listing. This sub report is grouped by Body System and Preferred Term.

Causality

Select the desired causality from the list.

Ignore - Counts events regardless of causality assessment.

Causal - Counts events where the causality is considered reportable in the Causality Category configuration in List Maintenance.

Not Causal - Counts events where the causality is considered non-reportable in the Causality Category configuration in List Maintenance.

As Determined - Counts events where 'As Determined' causality meets the above selected causality criteria.

As Reported - Counts events where 'As Reported' causality meets the above selected causality criteria.

Both - Counts events where both 'As Reported' and 'As Determined' causality meet the above causality criteria.

Either - Counts events where either the 'As Reported' or 'As Determined' causality meets the causality criteria.

Only Cases with HCP Reporter

Check this checkbox to include events for only those cases that feature an HCP reporter.

Diagnosis

Select this option to ensure that only events marked as diagnosis are counted.

Diagnosis & Symptoms

Select this option to ensure that all events are counted in the sub-report.

Separate Diagnosis & Symptoms

Select this option to include diagnosis and symptoms separately in the sub-report. Selecting this option means that the case numbers are separated by Diagnosis and Symptoms respectively.

Domestic Consumer Support

Select this option to enable domestic consumer support.

Print Unsubmitted

This option allows a user to print MedWatch or VAERS forms for U.S. cases.

Exclude Reports that are Non-Serious and Listed

Allows a user to suppress MedWatch or VAERS forms from printing for Non-Serious listed cases where all events are non-serious and listed for the datasheet specified.

Use Periodic numbering on the Reports

Numbers the requested forms with a periodic format. (Namely, Periodic Page 1 - 1, Periodic Page 1 - 2, Periodic Page 2 - 1, Periodic Page 2 - 2, etc.) An index with the Case Number is also included.