When the system opens the Worklist - Contacts screen, enter the information in the fields as necessary

Total Number of Rows

2. When the system opens the Worklist - Contacts screen, enter the information in the fields as necessary

Search Case

The following is an illustration of the Search Case section of the Worklist -- Contacts screen.

S/U/R Displays the Case Level Assessments:

■ S denotes Serious (Y/N)

■ U denotes Unlisted (Y/N)

■ R denotes Causality (Y/N) Note:

■ Unknown is treated as a "?"

■ When the user clicks the SUR link, the Case Summary gets displayed.

Description Displays the description of the Action Item in question.

Date Open Displays the date the action item was opened.

Date Due Displays the due date.

Days Open Displays the number of days for which the action item has been open.

Assigned To Displays the current owner or "Unassigned" user to the case Print List Button Allows the user to print the current worklist for reference.

Field Description

The following table lists and describes the fields in the Search Case section.

Filter Functions The Filter function enables you to search for entities in the worklist.

The following table below describes the options available in the Filter drop-down list.

Total Number of Rows The following is an illustration of the Total Number of Rows section

The following table describes the columns in Total Number of Rows:

Field Description

Filter Performs searches for worklist items on the basis of the filtering criteria selected here

Value Enables the user to select the Value as the search criterion Select Button Enables the user to open the selected or entered case ID.

Assigned To Enables the user to select the user to whom the case has been assigned.

View Individual Enables the user to view individual items assigned to this user group.

View Group Enables the user to view all items assigned to this user group.

View All Enables the administrator and workflow manager to see all items in the system.

Option Description

Case Number Displays the case number.

Note: The Assigned To option is not available if the user selects Individual radio button option from View.

Field Description

Case Number Displays the Case Number.

Note: Click the case number to open the case.

Study ID Allows the user to view the Study ID present in the case.

Reports

This section discusses the features available from Worklist - Reports page.

To view the Worklist Reports page 1. Select Worklist --> Reports.

2. When the system opens the Worklist - Reports screen, enter the appropriate information as necessary.

Search Case

The following is an illustration of the Search Case section of the page.

The following table lists and describes the fields in the Search Case section.

Description Displays the description of the Action Item in question.

Product Name Allows the user to view the Product Name of the Primary Suspect Drug.

Aware Date Displays the Aware Date of the Case. Aware date is the latest significant follow up which is received in the case or the Initial Receipt Date if there are no Significant follow ups present in the case.

Date Due Displays the due date.

Days Open Displays the number of days for which the action item has been open.

Assigned To Displays the current owner or "Unassigned" user to the case.

Print List Button Allows the user to print the current worklist for reference.

Field Description

Filter Function

The Filter function enables you to search for entities in the worklist. The following tables describes the options available from the Filter drop-down list.

General Usage Information When using filtering, be aware of the following:

■ The filter options have a Study ID element that enables the user to filter cases within the list (not deleted).

■ This option is a type ahead that enables users to enter values for studies defined in the configuration.

■ The type ahead feature limits the users to 25 items in the drop-down list.

■ When the user selects type ahead values, the system performs a like search.

■ The filter options have a Reporting Group element that enables the user to filter cases in the list.

Field Description

Filter Performs searches for worklist items on the basis of the filtering criteria selected here.

Value Enables the user to select the Value as the search criteria.

Search Button Enables the user to open the selected or entered case ID.

Assigned To Enables the user to select the person to whom the case is assigned.

View Individual Enables the administrator and workflow manager to see individual items in the system.

View Group Enables the user to view all items assigned to this user group.

View All Enables the administrator and workflow manager to see all items in the system.

Option Description

Case Number Displays the Case Number.

Reporting Destination

Displays the report destination (agency) for which the report is scheduled.

Product Displays only those products that occur in the given worklist,

considering other filter elements such as Case Owner, Assigned to, etc.

Event Preferred Term

Displays only those Event PTs that occur in the given worklist, considering other filter elements such as Case Owner, Assigned to, etc.

Report Status Displays the status of the report as Approved, Generated or Scheduled.

Case Report Type Displays only those Report Types that occur in the given worklist, considering other filter elements such as Case Owner, Assigned to, etc.

Report Form Displays the description of the report.

Due Date Enter a due date.

Note: The Assigned To option is not available if the user selects Individual radio button option from View.

■ This option is a type ahead that enables users to enter values for Reporting Groups defined for the reports in the worklist.

■ The type ahead limits the users to 25 items in the drop-down list.

■ When the user selects type ahead values, the system performs a like search.

■ The filtering elements have the Product and Reporting destinations removed from the list.

■ The user can mark multiple reports for approval by selecting the Mark Multiple for Approval option.

■ The user can view the Medical Summary report for all users who have permission to print the Medical Summary report.

■ The system displays the Report Details dialog and permits the user to enter the approval notes that are applied to all selected reports. The system skips any reports selected by the user that have the following statuses:

– Scheduled – Disapproved – Approved

■ The system hides the reports fields from the report details dialog and does not permit the user to access or modify any other tabs.

■ The system hides the Route button to prevent users from modifying the Report Status.

■ Workflow Enterprise users can access View and can modify the report details for all reports for all cases across multiple sites in their lists.

Filtering Reports by Report Destination When filtering by report destination, be aware of the following:

■ You can click the magnifying glass icon to filter reports by report destination. The system displays the standard lookup dialog.

■ The Report Destination filter multi-selection screen list contains the names of all agencies as configured in the Argus Regulatory Authority CodeList.

■ The system displays only the report rows that match the authority/agency you selected.

Filtering Reports by Product Family When filtering reports by product family, be aware of the following:

■ You can click the magnifying glass icon to filter reports by product family. The system displays the standard lookup dialog.

■ The Product Family filter multi-selection screen contains a list of all product family names as configured in the Argus Products Code List.

■ The system displays only the report rows that match the product you selected.

Filtering Reports by Country of Incidence When filtering reports by country of incidence, be aware of the following:

■ You can click the magnifying glass icon to filter reports by country of Incidence.

The system displays the standard lookup dialog.

■ The Country of Incidence filter multi-selection screen contains a list of all available countries.

■ The system displays only the report rows that match the country of incidence you selected.

Total Number of Rows

The following is an illustration of the Total Number of Rows section.

The following table lists and describes the columns in the Total Number of Rows section.

Field Description

Selected Allows the user to select the report.

Lock State Allows the user to view the Locked state of the case by the icon. If the locked icon is present, it indicates that the case is locked and vice versa.

Note: The lock icon is also displayed if the Case Status is Initial or Follow up. If the case is Follow-up, additionally, the Follow up number is also displayed.

E.g. Initial or F / U: 1.

The icon displayed in the lock state column, in the Worklist - New, Open and Reports screens denotes a SUSAR (Suspected Unexpected Serious Adverse Reaction) case.

Lock State Header Options

Click the Lock State header row. A pop-up appears listing the following sorting options:

■ Lock State

■ SUSAR

■ Exp/Per

These options enable you to sort cases based on the case categorization.

Status Displays the report status. Click the link displaying the report status to view the Report Details. Refer to the About the Report Details Dialog Box section for descriptions of each tab.

Case Number Displays the Case Number.

Note: Click the case number to open the case.

Country of Incidence Displays the Country of incidence.

Report Type Displays the Case Report Type.

The following table lists and describes the options available under Lock State.

Suspect Product Displays the Trade name for which the report has been scheduled. A "+"

displayed at the end of a Product Name indicates that more than one Suspect Company Products exist.

A Device Name is also displayed for those Reports which were scheduled for the Device.

Diagnosis Displays the Primary Event Diagnoses PT

Event Verbatim Displays the event verbatim (verbatim as reported) of the Primary Event.

S/U/R Displays the Case Level Assessments:

■ S indicates Serious (Y/N)

■ U indicates Unlisted (Y/N)

■ R indicates Causality (Y/N)

Note: Unknown is treated as a "?". When the user clicks the SUR link, the Case Summary gets displayed.

F or LT Indicates whether a case is fatal or life threatening as follows:

■ F identifies a Fatal (F) case

■ LT identifies a Life Threatening (LT)

Note: If any of the above are present together, then Fatal takes precedence followed by LT. If the case is neither of the above, No is displayed.

7/15 Displays 7 if the report is due within 7 days Displays 15 if the report is due in more than 7 days

Report Form Displays the description of the report. Click the link to view the DRAFT Report PDF.

Destination Displays the report destination (agency) for which the report is scheduled.

Initial / Follow-up (#)

Displays if the report is Initial or Follow-up.

If it is a Follow-up, the follow-up number is printed.

Due Date Displays the date the report is due.

Days Past Due Displays the number of days the report is past due date.

Days Open Displays the number of days since the report has been open.

Date Scheduled Displays the Scheduled Date of the report.

Assigned Displays the name of the individual to whom the case has been assigned.