Select inclusion criteria

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a periodic report. The top section of the dialog box allows you to specify the type of cases that are to be included in the periodic report.

Click Add to add a criterion. Select appropriate items from the list of items that appear.

Field	Description
Use Assessments in Cases	When selected, the PSUR Report will use the Case Event Assessment when performing datasheet listedness calculations.
Re-assess cases against datasheet in effect at the beginning	When selected, the PSUR will re-assess the cases in the line listing based on the Active Datasheet on or before the Start Date of the Reporting period.
Re-assess cases against datasheet in effect at end	When selected, the PSUR will re-assess the case in the line listing based on the Active Datasheets on or closest to the end date of the PSUR Reporting end date range without exceeding that date.
Expeditable Only	This checkbox is available only when an agency is selected in the Subject of Report tab. If you check this checkbox, only the cases classified as submitted expedited reports to the specified agency are used.
Exclude Follow-up Cases	Filters out follow-up Reports from the PSUR Line Listing Report.
Include Unlocked Cases	Allows you to include unlocked cases in the periodic report.
Advanced Condition	Allows you to specify an advanced condition that must be satisfied by each case that is included in the report. Ensure that the advanced condition or the advanced condition query set that is specified here does not contradict any other criteria specified in the dialog box.
Use Datasheet Assessment for UDF Tabulations	Allows you to select datasheet for a report to make UDF tabulations. If no datasheet is selected, the most conservative listedness is chosen. Namely, Unlisted followed by Listed.
Add Cases not included in previous reporting period	Allows you to add cases which were not included in the previous reporting period. You can enter the start date of the period in the Start Date field.
Dropdown list	Select the appropriate report type from the drop-down list.
Datasheet	This list allows you to specify which datasheet is to be checked to determine the listedness (listed or unlisted) of the case.
Serious/Non-Serious	If you select Serious and clear Non-serious, only cases having a serious event are included and vice-versa. If you select both Serious and Non-Serious the seriousness criteria is ignored.
Fatal/Non-Fatal	Select Fatal when at least one event has an event outcome of Fatal. If not, select Non-Fatal. If you select both Fatal and Non-Fatal, both types of cases are included.
Listed/Unlisted	Select Listed to view only Listedness values. If you select both Listed and Unlisted, all Listedness values (including Unknown) are included.
Related/Non-Related	Relatedness refers to the more conservative of reported or company causality. Select Related for any reportable causality type, and Non-Related for any non-reportable causality type.
HCP/Non-HCP	HCP refers to cases that identify a Health Care Professional in the Reporter section within the General tab of the Case Form.
Primary Reporter Only	This checkbox displays whether the Primary Reporter has been selected to determine the HCP status.