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. |
Parent topic: Prepare content for an ICH PSUR