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 will be included in the periodic report.

Field	Description
Case Creation Date	Allows you to specify a range of cases by the date when the case was created.
Case Receipt Date	Allows you to specify a range of cases by the initial receipt date. Note: The Date Range is only available when an unscheduled CTPR is being created. You must specify only one date range out of Case Creation Date and Case Receipt Date.
Case Locked/Archived Date	Allows you to specify the date when the case was locked/archived.
Use Current Version	Allows you to use the latest revision to populate the data within the selected reports.
Use DLP Version	Allows you to use the case data of the version as of the specified DLP Version.
Age Groups	Allows you to include or exclude cases based on the patient's age group. Select all the age group categories that apply.
Restrict Cases to countries where studies are active	References study configuration to determine if the case was submitted during the dates the study was active. Note: This option is available only if a study is selected from the Available Studies section in the License/Study tab. It should not be used for Centrally approved products (CAP), which only have an EU license.
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.
Datasheet for Listedness	Select the Datasheet to look against for Listedness when running the report. Note: Select the ALL datasheet to use the most conservative listedness for the primary event, or the Case Listedness for the tabulation.
Use Assessment in Cases	When selected, the CTPR 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 CTPR 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 CTPR will re-assess the case in the line listing based on the Active Datasheets on or closest to the end date of the CTPR Reporting end date range without exceeding that date.
Reference Type (Clinical Reference Data Element)	Select the reference type to be displayed on the Main Listing if Clinical Study Reference is selected as a Data Element in the Available Data Elements section of the Line Listing tab.
Expeditable Only	This option is enabled only when an agency has been specified on the Subject of Report tab. Check this option to include only those cases that have submitted expedited reports to the specified Primary Agency.
Exclude Follow-up cases	Follow-up cases are cases with a significant follow-up in the Clinical Trial reporting period where the initial receipt date is in a prior period. Check this option to exclude follow-up cases from appearing on the Clinical Trial report.
Include Unlocked Cases	Check this option to allow cases that have not been locked for reporting to appear on the report.
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, such as 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.