Specify summary tabulations for line listing

The Summary Tabulations tab enables you to specify which summary tabulations/Listings will appear along with the line listing.

Field	Description
Include Index of Cases in Line Listing	Create an index page of case numbers, for all cases included in the CTPR.
Include Summary of Cases Missing Assessments	This option creates a sub-report of cases missing one of the following items: Seriousness Case Causality Case Listedness Case Outcome Event Causality Event Listedness Click this checkbox to create one or both of the following sub reports: Cases Missing Assessments - This sub-report displays cases that have been included in the CTPR line listing, but one or more of the following have not been assessed: Case Seriousness Case Causality Case Listedness Case Outcome Event Causality Event Listedness Cases Not Included in Report - This sub-report displays cases that have not been included in the CTPR line listing as a result of missing one or more of the following items: Lock Status Safety Date Uncoded Event Causality
Count of Cases per Report Type	This option prints a Sub Report that counts the number of cases versus the Report Type, based on the cases within the CTPR. The Cases per Report Type can be either of the following: Count Cases with Initial Expedited Reports: Counts cases with initial Expedited report. Count of cases with Follow-up Expedited report: Counts cases with Follow-up Expedited report. Total Count of Initial Cases in the Report: Counts any (serious - non-serious) cases received during the reporting period. Total Count of Follow-up Cases in the Report: Counts any (serious - non-serious) follow-up cases entered during the reporting period. Cumulative Count: Count of cases received from the start of the trial.
Event Count per Study Drug	Creates a sub-report with Event count per Study Drug based on the selected causality. 2 configurations are possible as to allow for a count of related events vs. non-related events.
All Drugs in Single Table	Suppresses 0 current columns (with their cumulative) and print everything in a single cross tab.
Grouped by Drug	Prints a cross tab report for every product. Prints the cumulative totals even if the current period has no events.
Event Type to Include	Prints SUSAR events on the CTPR Report based on the option selected from the drop-down list: Separate counts of SUSAR and non-SUSAR events Prints SUSAR and non-SUSAR events listed separately. SUSAR events are marked with an asterisk Combined count of SUSAR and non-SUSAR event Prints SUSARs. Normal events are grouped into one (current functionality) Only count SUSAR events Prints Only SUSARs. Namely, non-SUSARs would not be printed.
Include Line Listing Tabulation	Select this checkbox to view a pre-defined summary tabulation of Report type, Seriousness and Listedness of all cases in the CTPR.
Include Initial Cases	Select this checkbox to include initial cases in the CTPR tabulation.
Additional Expedited Report Forms (CIOMS/MedWatch/VAERS)	Allows you to print CIOMS/MedWatch/AERS forms (as per selection) for its respective regulatory agency (as selection), for all cases in the report. It also provides an option to have (or not have) a watermark in the forms.

CIOMS reports—fields descriptions

Field	Description
Print CIOMS reports for serious/unlisted cases	Allows a user to print CIOMS I forms for all Serious or Unlisted (Case Level) cases appearing in the CTPR. CIOMS contain Internal or Other text printed on them when the CTPR is printed using the Internal or Other option.
Include Periodic Numbering on the CIOMS reports	Numbers the requested CIOMS I with a periodic format. (Namely, A-1-1 of 2, A-1-2 of 2, A-2-1 of 1, A-3-1 of 1 etc.). The index is modified to also contain the Periodic paging of each CIOMS report.

Cumulative summary—fields descriptions

Field	Description
Include Cumulative Summary	Select the checkbox to create a sub-report count of events, grouped by Product and Body System (SOC) and sorted by Preferred Term. The sub-report contains a previous date range count of events (comparative date range), a current date range count (current CTPR date range) and a cumulative count (all dates) of events assessed against the product(s) of the CTPR and matching the inclusion criteria.
Comparative Date Range	Allows a user to specify the previous date range as a comparison date for the events counted, and therefore should not overlap with the current date range specified on the CTPR inclusion criteria tab.

FDA CTPR support—fields descriptions

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. Note: This section can be used if the company has obtained an FDA waiver to submit a CTPR instead of an NDA report.
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	Select this checkbox to include events for only those cases that feature an HCP reporter.
Diagnosis	Select this radio button 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 all SUSAR events in the CTR Report.
Print Unsubmitted	This option allows a user to print MedWatch or VAERS forms for U.S. cases. The following types of cases will be excluded: Foreign Cases (Country of Incidence not equal to U.S.) Clinical Trial Cases (Case Report type in list maintenance has this type includes cases from clinical trials checked.) Literature Cases (Case Report type in list maintenance has this type include case from literature checked.) Cases with submitted expedited reports to the Agency selected in the CTPR.
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.