10 Reports: Periodic Reports

This chapter contains detailed information about Argus periodic reports and how to create and use them.

Periodic Report Types

This section lists the different Periodic Reports in Argus and discusses about each of them in detail. Place the cursor over the Periodic Reports option in the Reports tab to go to any of the Periodic Reports.

You can create four kinds of periodic reports:

Clinical Trial Periodic Reports
ICH PSUR Reports
US IND Periodic Reports
US NDA Periodic Reports

Storing Periodic Reports in Documentum

Argus Safety enables you store your Periodic Reports in Documentum.

When you approve an expedited report from within Argus, the system exports the report as a PDF file and saves it in the Documentum database by Argus Safety Service. From this point, you can perform document reviews within the Documentum system.

When the report is ready to be submitted, mark the report as submitted from within Argus. Argus Safety Service updates the status of the report within Documentum to Submitted.

If the report is to be transmitted via fax or email, Argus Safety Service marks the report as a successful submission in Documentum only after the fax or email transmission has succeeded.

Viewing a Summary of Periodic Regulatory Reports

You can select any of the following options in viewing the summary of a periodic regulatory report:

To view the regulatory reports for a particular case (scheduled, generated, and submitted), open the Regulatory Reports tab of the Case Form.
To view all scheduled, generated, and approved reports, as well as other outstanding action items assigned to you or your user group, select Reports in the Worklist menu.
To view a list of all scheduled, generated, and approved periodic reports, select Periodic Reports from the Reports | Compliance menu.

Using the Library Page

The periodic reports have a library page for the following reports:

PSUR
CTPR
IND
NDA

The following table lists and describes the fields on the Library Page

Field/Control Name	Purpose
Category	Enables the user to view the report Category.
Sub Category	Enables the user to view the report Sub Category.
Report Name	Enables the user to view the name of the Periodic Report
Inclusion Star Date/Stop Date	Enables the user to view the report start and stop dates as defined in the configuration.
DRAFT/FINAL	Enables the user to view the draft and/or final report
Author Created	Enables the user to view the name of the author who created the report.
Date Created	Enables the user to view the date the report was created.
Date Modified	Enables the user to view the date the report was last modified.
Justification	Enables the user to view the justification for updating the report. The system displays the standard Justifications dialog that contains the lasts justification entered by the user.
Search	When the user clicks Search, the system initiates the search operation. When the system displays the search results, the user can enter search parameters in various fields and click Search to narrow the search results.
Clear	Enables the user to clear user-entered data from the fields

When using the Library Page be aware of the following:

The system places the total number of records displayed on the library page in the Total Number of Row (x) read-only field in the Report header.
The user can select the number of cases to display from the Page Size drop-down list.
The page size drop-down list contains the following values:
- 50
- 100 (default)
- 250
- 500
- 1000
- 2000
The system displays the number of reports currently in view and the system automatically updates the range based on the selected page size. For example, if the user selects a page size of 100, the system displays reports in groups of 100.
The user can go directly to a range of cases from the Displaying Rows drop-down option.
The user can scroll through the reports page-by-page in increments as defined in the Page Size drop-down list.
The user can sort on all columns in the Reports view by clicking the column header. The system displays an up arrow or a down arrow depending on whether the column is sorted in ascending (A-Z, 1-10, etc.) or descending order (Z-A, 10-1, etc.).
Initially, the reports are sorted by Category.
The default sort order is ascending.
When you click the Filter icon, the system displays the filtering row to enable you to filter on any element.
The type ahead feature enables you to filter on any element except Draft/Final.
Click the appropriate icon to minimize the filtering options.
Click the X to close the filtering options.
If filtering criteria is defined, the system displays the filtering elements icon to indicate that filtering elements exist.
If filtering criteria is not defined, the system displays the no filtering elements icon to indicate that no filtering elements are defined.
The system enables you to perform a like search. For example, if the user searches for Cure, the system returns all elements that start with Cure.
The system enables you to perform wildcard searches. For example, if the user searches for %Cure, the system returns all elements that contain Cure.
When you click Clear, the system clears the filtering criteria from the fields.
Clicking the filter icon enables you to filter for reports in the list of reports.
The system saves all user preferences for future use. If the user has already entered filter elements, the system displays the filter details for the last search when it displays the dialog.
If another user is modifying a report, the system displays the following:
The report which is being selected is being used by XXXX and cannot be modified.

where:

XXXX is the full user name of the person using the report.

About CTPR: Clinical Trial Periodic Reports

The Clinical Trial Periodic Reports (CTPR) are created to report the IND Annual reports and EU Clinical Trial Directive line listing reports to FDA. Surrounding text describes rptctpr.gif.

To create Clinical Trial Periodic Reports

Select Reports --> Periodic --> CTPR (Clinical Trial Periodic Reports) to open a list of CTPR Reports.
To create a new report from an existing report in the list, click Copy or Modify.
Click New Report to create an entirely new report. The Clinical Trial Periodic Reports dialog opens.
Enter an appropriate name for the report under Report Name.
Use the tabs in this dialog to configure the CTPR.

General Usage Information

When using the CTPR, be aware of the following:

The system enables you to group cases by Product Name and Drug Regimen Frequency:
Product Name
- This option enables you to group the Product Name - Formulation - Concentration with Units when the elements are separate with a hyphen ( - ).
- If an element is missing, the system does not print the hyphen ( - ).
- The system groups the cases based on the primary drug in the report.
Dosage Regimen Frequency
- This option enables you to group the frequency of the primary dosage regimen for the primary drug in the report.
- The system prints Frequency: followed by the frequency as defined above.
You can select datasheets for specific report types similar to the PSUR Report for the Inclusion criteria. If you select any rows in the inclusion criteria, the system disables the Datasheet selection dialog.
Report Type.This portion lists the report types (configured in Code List | Report Type) the report will be run against (LM_REPORT_TYPE). The user must select a report type so the system knows to save the criteria row.
Serious Criteria.This enables you to specify the seriousness of the cases for the selected report type as follows:
- Serious.Case Level or Primary Event is Serious.
- Non-Serious.Case Level or Primary Event is Non-Serious.
- If you select both Serious and Non-Serious, the system ignores the criteria.
- Fatal. At least one event has a Fatal event outcome.
- Non-Fatal.No events have a Fatal event outcome.
- If you select both Fatal and Non-Fatal, the system ignores the criteria.
Listedness.
- When using the case level assessment, the system does not consider the datasheet. Cases appear in the PSUR if the case level assessment matches the selected criteria.
- When using the primary event assessment in conjunction with a datasheet, the system uses only the As Determined listedness for the primary event when determining whether a case should be included in the PSUR report.
- If both Listed and Unlisted are selected, the system ignores the criteria and includes all listedness values (including Unknown).
Datasheet.This enables you to specify which Datasheet to use when looking for Listedness (LM_DATASHEET). The system uses the datasheet criterion only when you select the primary event assessment as the CMN_PROFILE assessment.
When you select the <ALL> datasheet option, the listedness for the primary event on at least one datasheet must match the selected criteria.
Related/Non-Related.
- When using case level assessment, cases appear in the PSUR when the case level causality matches the selected criteria.
- When using the Primary Event assessment, cases appear only if the causality for the primary event as reported or as determined matches the selected criteria.
- When using the All Events assessment, cases appear if any case events with as reported or as determined causality match the selected criteria.
- If you select both Related and Non-Related, the system ignores the related/non-related criteria.
HCP/Non-HCP. To have a case included in the PSUR, you must identify at least one case reporter as a HCP or Non-HCP. If this is being used in conjunction with the Primary Reporter Only checkbox, the system evaluates only the primary reporter for this criterion.
Primary Reporter Only. This enables the system to perform the HCP/Non-HCP check against only the primary reporter. This updates the entire configuration whether checked or unchecked.
You can copy an existing template by clicking the Create from Template button on the CTPR reports list.
When you click Create from Template, the system displays the Create from Template dialog.
You can choose the CTPR Group Name (as configured in the Product Name configuration) from a type ahead field.
When you enter the CTPR Group Name in the Select CTPR Group Name field and the From and To dates in the Create from Template dialog and click OK the system does the following:
- Saves the CTPR Configuration with the new dates.
- Replaces the products in the list of selected products with all products as defined for the selected CTPR name.
- Replaces the periodic report name in the newly configured periodic reports with a new name in the following format:
  
  XXXX: YYYY to ZZZZ
  
  where:
  
  XXXX is the selected CTPR Name.
  
  YYYY is the From Date entered by the user.
  
  ZZZZ is the To Date entered by the user.
- Replaces the date ranges for the From and To date fields only for the Periodic Report.
- Bases the remaining configuration, including the security permissions, on the selected CTPR template.
When you enter the CTPR Group Name in the Select CTPR Group Name field and the From and To dates in the Create from Template dialog and click Print and Save, the system does the following:
- Saves the CTPR Configuration with the new dates.
- Replaces the products in the list of selected products with all products as defined for the selected CTPR name.
- Replaces the periodic report name in the newly configured periodic reports with a new name in the following format:
  
  XXXX: YYYY to ZZZZ
  
  where:
  
  XXXX is the selected CTPR Name.
  
  YYYY is the From Date entered by the user.
  
  ZZZZ is the To Date entered by the user.
- Replaces the date ranges for the from and to date fields only for the Periodic Report.
- Calls the Report Batch Printing dialog.
- Bases the remaining configuration, including the security permissions, on the selected CTPR template.

Common Tab Fields

The Report Name, Report Category and Report Sub-Category fields are common to all tabs of the Reports.

The following table below describes these fields:

Field	Description
Report Name	Enter a name for the Report. The name entered here is displayed in the Reports menu.
Report Category	Select a category for the Report. This is displayed in the Reports menu. Tip: Select New to define a subcategory within the report category. The Periodic Report Category dialog is displayed. Enter a category name in Category and click OK. The category is entered in the Report Category drop-down list.
Report Sub Category	Select a subcategory for the report. Tip: Select New to define a subcategory within the report sub-category. The Periodic Report Category dialog is displayed. Enter a category name in Category and click OK. The category is entered in the Report Sub-Category drop-down list.

Field

Description

Report Name

Enter a name for the Report. The name entered here is displayed in the Reports menu.

Report Category

Select a category for the Report. This is displayed in the Reports menu.

Tip: Select New to define a subcategory within the report category.

The Periodic Report Category dialog is displayed.

Enter a category name in Category and click OK.

The category is entered in the Report Category drop-down list.

Report Sub Category

Select a subcategory for the report.

Tip: Select New to define a subcategory within the report sub-category.

The Periodic Report Category dialog is displayed.

Enter a category name in Category and click OK.

The category is entered in the Report Sub-Category drop-down list.

Subject of Report Tab

The Subject of Report tab is used to configure the report header and to specify the agency, products, etc. for which the CTPR is applicable.

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The following table lists and describes the fields on this tab.

Field	Description
Available Reporting Destination	Displays the list of configured Regulatory Agencies. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list. Select multiple agencies by holding the CTRL key when you click them. Likewise, select an agency from the Selected Destination list and click Remove to remove it from the selected destination.
Primary Agency	Select the primary agency for the report. Note: When you submit a Periodic report, it goes to the selected Primary Agency.
Selected Reporting Destination	Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list. Select multiple agencies by holding the CTRL key when you click them. Likewise, select an agency from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.
Report #	Enter a report number for this report
Report Title	Enter a report title for this report
Ingredient	Automatically displays the "Ingredient" as provided in the Subject of Report dialog. Note: You can choose whether to view this field or not. Click the checkbox displayed with this field to hide or view it.
Trade Name	Automatically displays the "Trade Name(s)". Multiple trade names are also displayed together, separated by commas. Note: You can choose whether to view this field or not. Click the checkbox displayed with this field to hide or view it.
International Birth Date	Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product. Note: You can choose whether to view this field or not. Click the checkbox displayed with this field to hide or view it.
Report Footer	Enter the footer for the report
Print all configuration criteria on separate cover page	Mark this box to print out the configuration of this report when the report is printed. This is only available when PDF option is selected during printing.
Print page numbers on reports	When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations. If this checkbox is not checked, the following occur. The "Include Periodic Page Numbering" option in the CTPR Summary Tabulations CIOMS Report section is inactive and grayed out. The "User Periodic Numbering on the report" option on CTPR Summary Tabulations FDA PSUR support section is grayed out and inactive. The "Additional Separate Page Numbering for UD Summaries" option on the CTPR UD Summaries tab is grayed out and inactive. The system removes all existing report page numbering and the option to check page number check boxes on the report configuration tabs are grayed out and inactive.
Allow access to report cases through Hit List	When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.

Product Selection Tab

The Product Selection tab enables you to select the products included in the CTPR report.

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The following table lists and describes the fields on the Product Selection tab.

Field	Description
Available Ingredients	Displays the list containing the Ingredients used for the product configuration. Select an ingredient from the list displayed in Available Ingredients and click Add/Remove to add/remove the ingredient. You can select multiple ingredients at a time.
Filter	Enter an Ingredient name and click Filter to search for the entered ingredient within the Available list of Ingredients.
Selected Ingredients	Displays the list of ingredients selected from the Available Ingredients list.
Available Countries	This list is auto-populated and displays only the countries with a license containing the ingredient selected from the Available Ingredients list.
Selected Countries	Displays the countries selected from the Available Countries list.
Indication	This list contains the Indication configured for the product containing the ingredients in the Available Ingredients section. The selections made from this list get displayed in the Available Products section. Note: You can select multiple Indications from the list at a time by pressing the CTRL key and clicking the different Indication entities.
Formulation	This list contains the Formulation configured for the product containing the ingredients in the Available Ingredients section. The selections made from this list get displayed in the Selected Products section. Note: You can select multiple Formulations from the list at a time by pressing the CTRL key and clicking the different Indication entities.

License/Study Tab

The License/Study tab is used to configure the report header and to specify the agency, products, etc. for which the CTPR will be applicable.

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The following tables lists and describes the fields on the License/Study tab.

Field	Description
Available Licenses	Contains licenses that use the ingredient selected in the Ingredient field. This field is automatically populated when an ingredient has been selected.
Selected Licenses	Displays the licenses selected from the Available Licenses list by clicking Add/Add All. You can select Licenses that are related to different ingredients for a report.
Available Studies	Contains studies that use the ingredient selected in the Ingredient field. This field is automatically populated when an ingredient has been selected.
Selected Studies	Displays the studies selected in the Available Studies list by clicking Add/Add All. You can select studies that are related to different ingredients for a report.

Inclusion Criteria Tab

The Inclusion Criteria tab allows you to select search parameters for inclusion of cases in a periodic report.

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The top section of the dialog allows you to specify the type of cases that will be included in the periodic report.

The following table lists and describes the fields on the Inclusion Criteria tab.

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.
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.
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, i.e. 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.

Using the DLP Version

DLP primarily uses two processes:

Next Case Revision
Last Case Revision

DLP Options

Be aware of the following DLP Options.

Last Completed Version -- This option always uses the case version with the last lock that existed prior to the DLP or "As of reporting" date. This option does not enable data cleaning

Note: DLP saves only the last revision when multiple saves are performed in the same job session.
Next Completed Version -- This option uses the current case lock or the next following case lock if the case version was initiated prior to the DLP or the "As of reporting" date with two exceptions:
- If there is no case lock for the current version that was received prior to the DLP, the last (current) case revision is used.
- If there is a case version after the case lock that was created for the purpose of data cleaning, it is to be used instead of the first locked case revision.
- If there are multiple contiguous case versions following the first case lock for the purpose of data cleaning, the last case data cleaning version is used.
  
  Note:
  The Data Cleaning option is only available with the DLP option Use Next Completed Version (Includes Data Cleaning).

Dates for Using DLP/"As of reporting" Function

You can perform DLP queries for the following:

Receipt Date -- date entered by the user during case creation
Initial / Follow up Receipt Date
Safety / Safety Follow up Receipt Date
System Date (Case Creation Date) - date the case was physically entered

As of Reporting Function

The as of reporting function returns the same case version results as the DLP Options, with the only difference that the date depends on the "as of date" instead of a DLP date.

Availability of DLP/As of query functionality

The DLP / as of query functionality is available in the following application modules:

Periodic Reports
- PSUR including all User defined Tabulations and expedited reports within the Periodic Report
- CTPR including all User defined Tabulations and expedited reports within the Periodic Report
- IND including all User defined Tabulations
- NDA including all User defined Tabulations and expedited reports within the Periodic Report
System Reports
- CIOMS II Line Listing
- CDA Reports
- Case Listing Reports

Line Listing Tab

The Line Listing tab contains the following fields and sections:

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Field	Description
Include Line Listing	Allows you to select whether you want the Line Listing Data Elements printed with the CTPR Report.
Blind Line Listing and Summary Tabulations	Hides the selected listings from being displayed

Available Data Elements

A number of optional fields are available in the Available Data Elements frame. Select the check box associated with a data element to add the data element to the report. Be aware of the following:

By default, the system print s unavailable fields on the report, and they cannot be changed.
Required data elements are printed as columns in the report. The optional data elements are printed as separate rows below the column data for each case.

Refer to the following table for a list of data elements on this tab.

Data Element	Notes
As Determined Causality	Optional.
As Determined Listedness	Optional.
As Reported Causality	Optional.
Case Abbreviated Narrative	Required and multi-language available.
Case Classifications	Multiple classifications are displayed in separate lines.
Case Central Safety Date	Optional.
Case Comment Text	Optional.
Case Initial Receipt Date	Optional.
Case Listedness	Optional.
Case Narrative	Optional.
Case Number	Required.
Case Outcome	Required.
Case Report Type	Required.
Case Seriousness?	Optional.
Clinical EUDRACT # Number	Optional.
Clinical Study Reference	Optional.
Company Agent Causality	Optional. Displays event causality from product name. Multiple causalities are displayed in separate lines.
Country of Incidence	Required.
Death Cause	Optional. Multi-language available.
Death cause as reported	Optional
Death Cause HLGT	Optional.
Death Cause HLT	Optional.
Death Cause LLT	Optional.
Death Cause SOC	Optional.
Dosage Regimen Batch/Lot #	Optional.
Dosage Regimen Daily Dose	Required.
Dosage Regimen Duration	Required.
Dosage Regimen Frequency	Required.
Dosage Regimen Route of Administration	Required.
Dosage Regimen Start Date/Time	Required. For the selected product the report is based on. List for all dose regimens.
Drug Dechallenge?	Required.
Product Indication	Optional. For the selected product the report is based on.
Product Indication HLGT	Optional. For the selected product the report is based on.
Product Indication HLT	Optional. For the selected product the report is based on.
Product Indication LLT	Optional. For the selected product the report is based on.
Product Indication SOC	Optional. For the selected product the report is based on.
Drug Rechallenge?	Optional.
Event Description as Reported	Required.
Event Onset Date/Time	Required.
Event Preferred Term	Required.
Lab Data - Tabular	Optional.
Literature Author	Optional.
Literature Journal	Optional.
Literature Pages	Optional.
Literature Title	Optional.
Literature Volume	Optional.
Literature Year	Optional.
Literature reference	Optional.
Outcome of Event	Optional.
Patient Age	Required.
Patient Gender	Required.
Patient Initials	Optional.
Patient Relevant History	Optional. Multi-language.
Patient Subject #	Optional.
Product Name	Optional. Displays "product name (generic name) product type, formulation, concentration unit" "daily dose," "dose dose_freq, route"
Product Name Report Inclusion	Optional. Prints the Products that were part of the CTPR Report for the case. Displays "product name (generic name) product type, formulation, concentration unit" "daily dose," "dose dose_freq, route"
Report Comment	Optional.
Study ID	Optional.
Study Other ID	Optional.
Study ID Protocol #	Optional.

Selected Data Elements

This section lists the selected elements and enables you to arrange the order in which these are to be printed. Click the Up or Down buttons to arrange the listed elements above or below in order of priority.

Options

Field	Description
MedDRA Hierarchy from Cases/Dictionary	Select Cases to populate the data from the case data. Select Dictionary to populate the data from the MedDRA dictionary.
Print Only the Term (Preferred Term or Lower Level Term)	Prints only the event Preferred Term (PT) or event Lower Level Term (LLT) as per the selected radio button. Select the PT option to print only the preferred term and not the verbatim description.
Print Dose Text in place of regimen dose	Prints the dosage and frequency information from Dose Description field instead of Regimen Dose.
Indicate if case was expedited previously	This checkbox is selected if a primary agency has been selected in the Subject of Report tab. Cases for which an expedited report was previously submitted to the selected authority are marked with an asterisk.
English Language	Provides the option to print the descriptions in English
Local Language	Allows a user to specify which Local language for a multi-language field is to be printed i.e. the Abbreviated Narrative field.
Print event info (Serious, Un-listed, Related) as Column	Select this check box to print the Seriousness, Listedness and Causality under the Event Verbatim column. Note: Events having listedness of "Unknown" are considered "Unlisted." If only diagnoses are assessed for event assessment, the events which are associated with a Diagnosis but have been marked with Diagnosis as "Np" display " - " for both listedness and causality.
List cases only once, under the primary event	Select this option to view the details of cases in the Main Line Listing only once under the Primary Event
List cases under all events, details under the primary event	Select this option to view the details of cases in the Main Line Listing only once under the Primary Event, while non-primary events are listed under their respective event hierarchy with a reference to the primary event body system. Therefore, use this option when grouping on Main Line Listing is by the Event Body System.
Print Product Indication for the product selected in the report	Select this option to print Product Indication for the product selected in the report.

Grouping Tab

Refer to the following table for a description of items in the Grouping tab.

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Field	Description
Available Groupings	Allows a user to group cases together from the given list. Select the desired groupings from the list and click Add to move the grouping to the Selected Groupings list. Up to 10 grouping options can be selected.
Selected Groupings	Lists the added groupings made available from the Available Groupings list, and reports the groups in the order they were selected.
Ascending	Select this check box to sort the selected entities in ascending order.
Page Break	Select this check box to start the cases from a new page, while also keeping the sorting together for every selected page break.
Available Sortings	Allows a user to sort cases together from the given list. Select the desired sortings from the list and click Add to move the sorting to the Selected Sortings list.
Selected Sortings	Allows a user to further sort cases without a total count for each sorted item. Up to 3 levels of sorting can be selected from the Available Sortings list.

Summary Tabulations Tab

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

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The following table lists and describes the fields on the tab.

Field	Description
Include Index of Cases in CTPR	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 Study Drugs in Single table	Suppresses '0' current columns (with their cumulative) and print everything in a single cross tab.
Grouped by Study 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 i.e. non-SUSARs would not be printed
Title	Enables you to select a title.
Include Line Listing Tabulation	Select this check box to view a pre-defined summary tabulation of Report type, Seriousness and Listedness of all cases in the CTPR.
Include Initial Cases	Select this check box to include initial cases in the CTPR tabulation.
Include Follow-up Cases	Select this check box to include follow-up cases in the CTPR tabulation.
Include Summary of Unlocked Cases	Enables you to print the list of Case Numbers that are included in the Periodic Reports but are not locked.

CIOMS Reports

Field	Description
Print CIOMS reports for serious/unlisted cases	Allows a user to print CIOMS I forms for all Serious/Unlisted (Case Level) cases appearing in the CTPR. Note: 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. (i.e. 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

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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.
Serious	Select this check box to include only serious events.
Unlisted	Select this check box to include only unlisted events selected in the Datasheet on the "Inclusion Criteria Tab." If no datasheet is selected, then any Unlisted license is included.
Related	Select this check box to include only those events that are assessed as Related or Causal.
Diagnosis	Select this radio button to include only those events that are marked as diagnosis "Yes" and are without any symptoms associated with diagnosis.
Diagnosis & Symptoms	Select this option to include all events in the sub-report.
Separate Diagnosis & Symptoms	Select this option to include all SUSAR events in the CTR Report.

FDA CTPR Support

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Field	Description
FDA CTPR Support Section
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 check box 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.
Domestic Consumer Report	Enables you to select domestic consumer 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 PSUR.
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. (i.e. 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.

Single Case Submission Support

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Field	Description
Single Case Submission Support Section
Generate Periodic ICSR Submissions for any cases in this Periodic Report that does not have at least one scheduled single-case report during the reporting period to the following Reporting Destination(s): Modify	Select this check box to generate the E2B Reports only for the cases, where a Periodic E2B Report for the message type chosen, does not exist. Select one or more trading partners from the list box. Important: Any case that does not have an expedited or single case periodic submission to a trading partner, must have an E2b report scheduled as a part of the Periodic submission. Click Modify to select a different Reporting Destination.
Schedule these single-case Periodic Reports to the following Reporting Destination	Select a single-destination trading partner for Periodic Reports from the drop-down list box.
Using the Message Type	Select the required message type from the drop-down list box

UD Summaries Tab

The UD Summaries tab allows you to specify which summary listings will appear along with the line listing.

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Field	Description
Include these summary tabulations/listings based on the set of cases presented in the line listing	Allows you to select from pre-configured summary tabulations/listings based on Case Data Analysis, Case listing or CIOMS II line listing reports. These tabulations are based only on the data included in the line listing. Select the Exclude Follow-up Cases check box to filter out follow-up cases from the attached report. Note: If the Exclude Follow-up Cases option is selected on the Inclusion criteria tab, this option is ignored and follow-up cases are always filtered out.
Include these summary tabulations based on all cases	Allows for additional sub-reports based on the 'Case Data Analysis' template, to be included as an output for the all cases in the database that meet the CTPR inclusion criterion for all dates.
Include these summary tabulations/listings based on the Date Range	This option allows for additional sub-reports based on Case Data Analysis, Case listing or CIOMS II line listing reports to be included as an output for the cases meeting the CTPR inclusion criterion for the Date Range specified when adding the sub-report. The dates are based on either the "Case Creation Date" or the "Initial Receipt Date" as entered on the CTPR Inclusion Criteria tab. Click the checkbox to the right of the sub-report to ignore considering follow-up cases for the sub-report.
Additional Separate Page Numbering for Summaries	Enables you to include additional separate page numbering for summaries.

Scheduling Tab

The Scheduling tab allows you to specify details of how often the periodic report will be scheduled.

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The following table lists and describes the fields on the Scheduling tab.

Field	Description
Start Date	This is the International Birth Date for the CTPR product. This date is computed as the earliest Awarded date for any license of any type.
Recalculate	Allows a user to recompute the International Birth Date of the CTPR Product. This date can be overwritten/manually entered, if needed.
Report is due xx days after selected end date (creation or receipt date)	Enter the number of days when the report will be due after the end date specified for the scheduling period.
Automatically generate report xx days before/after selected end date at xx:xx	Allows a user to specify the timing of the automatic report generation, by specifying the number of days before/after the selected end date of the report.
Group	Allows the user to select the group to which the automatically generated report is to be assigned

Scheduling Frequency

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The following table lists and describes the fields in the Scheduling Frequency section.

Field	Description
Frequency	Allows a user to specify the interval required for this scheduling period.
Start	Allows the user to specify when the scheduling period starts.
End	Allows the user to specify when the scheduling period starts.
Add	Allows a user to add another scheduling interval.
Delete	Allows a user to delete a scheduling interval.

Security Tab

The Security tab is used to configure the security level for the CTPR.

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The following table lists and describes the fields on the Security tab.

Field	Description
Share this Report with Other Users	Click this check box to share this report with other users. Specify the privileges to be granted to groups by adding the group name from the Users Groups list to either the "Execute" or "Modify and Execute" list. A user group can exist in only one of these access lists.
User Groups	The groups listed here have no access to the CTPR report template. Click Add or Remove to move them to another access list.
Execute	The groups listed here have read and execute access to the shared CTPR report template.
Modify & Execute	The groups listed here have read, execute and modify access to the shared CTPR report template.

About ICH PSUR Reports

The Periodic Safety Update Reports (PSURs) are created on a periodic basis to enable regulatory authorities to monitor the safety of a marketed product. This information is used to view new data about the product acquired from appropriate sources. It helps relate this data to the patient exposure and also indicates whether changes should be made to the product information in order to optimize the use of the product. Requirements on the due date of periodic reports may differ for different regulatory authorities.

To create Periodic Safety Update Reports (PSURs)

Select Reports --> Periodic --> ICH PSUR Reports. A list of PSUR Reports opens in the right frame.
Click Copy or Modify to create a new reports from an existing report.

OR

Click New Report to create an entirely new report.
When the system opens the ICH PSUR Line Listing Reports dialog box, enter an appropriate report name in the Report Name field.
Use the tabs to configure the PSUR.