13 Dashboards

13.1 Open Case Summary Reports

To view a summary of all the open cases, select Dashboards > Open Case Summary.

• The case summary appears in PDF format.

• The cases are sorted in ascending order as per the number of days the case has been open.

• The Date Received column prints the initial receipt date or the latest follow-up date for the case.

• If there are no follow-ups for a case, the system calculates open cases based on the initial receipt date.

• If there are follow-ups for a case, the system calculates the days open based on the most recent follow-up in the case. If the latest follow-up date is older than the previous follow-up, it considers only the last follow-up.

13.2 Open Action Items Reports

To view all outstanding action items, select Dashboards > Open Action Items.

The Open Action Items Report appears in the PDF format and is sorted as per the Case ID of the listed cases.

13.3 Quick Signal Report

To view the changes in number of events over the past year, select Dashboards > Quick Signal Report.

The Product Browser with a summary of events, which have triggered the signals appears.

13.4 Increased Frequency Wizard

The wizard lists the events that have occurred at increased frequency for a given product and indication, based on a FDA formula (modified t-test).

To generate an Increased Frequency Wizard:

1. Select Dashboards > Increased Frequency.

2. Enter the parameters, and click Generate.

   Field	Description
   Product	Basis of the report.
   Indication	Indication of the selected product.

   
   

To open the Increased Frequency Wizard:

• Select Utilities > Increased Frequency Wizard, and follow the instructions.

13.5 Expedited Report Status

1. To search for and field information about the status of expedited reports, select Dashboards > Expedited Report Status.

   Alternatively, go to Worklist Group > Expedited Reporting Status.

2. In the Search Case section, enter the parameters, and click Retrieve.

   Field	Description
   Serious Case	Displays if the case is serious or not. If Yes is selected, the seriousness criteria are enabled. Note: A case that does not have a seriousness specified (i.e. blank) is treated as serious.
   Death/LT Only	Includes any case that has any of the Fatal or Life-Threatening seriousness criteria.
   All Other Serious	If this seriousness criterion is checked, the case only gets included if any of the following seriousness criteria of any event are checked: Hospitalized, Disability, Congenital Anomaly, Medically Significant, Intervention Required or Other.
   Retrieve	Prints the currently selected dashboard, including filter criteria.

   
   

3. To view the Grouped Expedited Reporting Status (Pie chart), click the color-coded areas of the pie chart.

   All the reports or cases opens within that section instead of just the bar.

4. To view the Expedited Reporting Status (Bar chart), click a bar.

   Worklist with the cases that belong to the reports or the actual reports appears. These reports belong to the specified time-frame.

Note that, when you have access to Expedited Report Status, you would also have access to the Report Due Soon dashboard.

13.6 Workflow Status

You can view the workflow status based on case owner, site, case seriousness, and other criteria.

To view the Workflow Status

1. Select Dashboards > Workflow Status.

2. In the Search Case fields, enter the parameters, and click Search.

   Workflow Status appears on the Worklist Group menu.

   • To open the list of cases, click a bar graph, and select from a dashboard menu.

     To drill down on the specific workflow state details, click the graphical bars.

   • If no updates are made to cases during case processing, the cases are displayed based on the number of cases you clicked during the drill down.

   • If one or more cases change workflow state between loading the dashboard screen and loading the worklist-specific screen, a discrepancy in case numbers may occur.

   • The system maintains user preferences when you return to the Workflow Status Dashboard.

   • By default, only the first filtering results appear, to view other filter options, click More Filtering.

     Use CTRL and Shift keys to make multiple selection for a filter.

     • The Site filter displays all active (undeleted) sites in the Argus Code List. However, the LAM sites are not displayed.

     • The Workflow State filter displays all active (undeleted) workflow states, except archived or closed in the Argus Utilities - Configuration.

     • The Date Range function selects last month as the default value for the range.

       The Aware Date is evaluated to fall in between the date range specified in the Date Range filter.

     • The Serious or Non-Serious filter further provides more sub-filtering options.

     • For Project ID filter, the values are configured in the Argus Utilities Protocol ID Code List.

     • The Default Report Configuration filter returns all cases for the current month when no other filters are used. The cases are evaluated based on the Aware Date.

   • To go to worklist specific screen, double-click the Bar Graph.

     Bar graph colors indicates: the following statuses:

     • Red—Late cases

     • Yellow—Outside of normal cases

     • Green—Normal cases

13.7 Reports Due Soon

As report scheduling is commonly configured to be executed when significant changes are made to a case, the expedited reports may be delayed if a case never gets locked. You cannot know that a report is late if it has never been scheduled. To address this potential compliance issue Argus Safety assesses case reportability prior to formal report scheduling. Workflow and Expedited Status monitoring screens identify unlocked cases due soon.

• To view a list of unlocked cases with reports due, select Dashboards > Reports Due Soon.

  The Unlocked Cases with Possible Reports Due Soon screen appears.

  Field	Description
  Graph	Red bars indicate that the report is likely to be due within the next 5 days. Yellow bars indicate that the report is likely to be due in the next 10 days.
  R/Y	Number of cases in Red/Yellow

  
  

• The Workflow and Expedited status include another report with cases that have not had reports scheduled but that may generate a report with a due date in the near future. This graph is displayed below the graph detailing the actual case status. The reports included in this sub-dashboard are limited to the filter criteria specified for the main dashboard.

  To view a Worklist with cases of the selected state (red or yellow), click the graphical bar.

13.8 Personal Argus Status

1. To view a list of Cases Assigned, Contact Log Entries and Action Item Entries specific to the logged-in user, select Dashboards > Personal Argus Status.

   The parameters appears as per the selection.

   Field	Description
   Country (Case Number)	Displays the name of the country to which the case belongs, with the Case Number listed in brackets.
   Overdue Action Items	Displays the Action items where the action item due date is before today's date (system date)

   
   

2. To move a case to open worklist, from the Cases Assigned section, right-click a case row, and select Accept.

3. To search for a case, on the Home page, in the Case Quick Launch field, enter the case number, and click Open.

   1. To view case details, click the link displaying a case number.

   2. To enable a section, check the respective header checkbox.

      The sections for which the checkbox is not checked are appears at the bottom of the screen.

13.9 Case Workload

To view the case workload for individuals and one or more sites, select Dashboards > Case Workload.

The Case Workload feature is available for Workflow Managers only (administrator). For example, if a user belongs to a group which has access to this menu option but is not a Workflow Manager, this option will not be displayed.

The Case Workload parameters displays the specific Worklist where the user can view the case numbers. Click + to view the next level and expand the parameter.