Setting up Preferences

In the ARISg application, select Tools->Options->Preferences to invoke the Preferences page. This page is divided into seven tabs:

Specifying General Preferences

  1. Select the General tab.

  1. Provide the details.

Field Description of General tab

 

AER List

The AER List page displays recently used and currently selected AERs. This can be very handy if you are working on the same cases for a given time.  Using this page, you can save the time you spend retrieving AERs by specifying selection criteria.  Even if Display AER window at startup is disabled, you can invoke The AER List page at any time by selecting 'AER List’ icon on the tool bar.  When you finish the operation, you can toggle back to ARISg with the 'ARISg’    icon on the AER list page.

If the Display AER list window at startup option is selected in the Tools > Options > Preferences (AER List section), then by default the Recent AERs tab is displayed in the AER List page on logging on to the application.

If the Case journal reminder at startup option is selected in the Tools > Options > Preferences (AER List  section), then by default the Pending Case Journal tab is displayed in the AER List page on logging on to the application irrespective of the user privileges assigned.

If both (Display AER list window at startup and Case journal reminder at startup) options are not selected in the Tools > Options > Preferences (AER List section), then by default, the Recent AERs tab is displayed in the AER List page.

If both (Display AER list window at startup and Case journal reminder at startup) options are selected in the Tools > Options > Preferences (AER List section), then by default, the Pending Case Journal tab is displayed in the AER List page.

 

Note:  If you do not have access to a case then that case is not retrieved and displayed in the AER List page.

Specifying Preferences for Generating Reports

  1. Select the Reports tab, specify the preferences for generating reports.

 Field Description of Reports tab

 

  1. Click Save to save your preferences.

OR

Select Close to cancel the operation.

Report Generation Features

The following features are provided for generating reports in ARISg.

Report Printing, Faxing, and Storing

In ARISg, you can print the reports to either from a CASE or a printer. ARISg uses the standard Pages printer setup. The reports in the system can be printed to any printer supported via Pages. You can also print to file for historical records.

When used in conjunction with Microsoft Fax (provided with Pages 95 and NT 4.0), you can fax any ARISg generated report from ARISg to any fax machine.

The generated report is displayed in the .pdf format in Adobe Acrobat application. Click the Print icon from the tool bar or click CASE >Print from the menu bar of the Adobe Acrobat application to print the reports.

Draft Reports

ARISg includes a ’Draft’ feature that allows you to print reports with a ’DRAFT’ watermark, to avoid confusion between these reports and the final reports for submission.  

Since security restrictions apply to this feature, any user can be restricted to only DRAFT output. Only authorized users can generate final reports.

Flexibility

Parameters allow you to customize the system to meet your company’s needs. The system generates reports based on the parameters you set.  

It is possible to include/exclude data, change the format of the data and use different logic to generate any report thus satisfying the authority requirements and the reporting company.

These parameters do not require coding; they are available through the same GUI used for data entry. Most parameters are set globally. However, many reports also support run-time parameters. Run time parameters are set when the report is generated.

Report Generation Options

ARISg supports report generation of the following types:

This can be set under Tools > Option > Preferences > Reports in ARISg Main Menu.

Online Generation of Report

To generate the reports online:

  1. Select Tools > Options > Preferences > Reports in ARISg Main Menu.

  2. In the field ’Report Generation Type’, select the  ’Online’ option.
    The report generated online can be viewed immediately.

Background Generation of Report

You can generate the reports in background mode as well. This means, while the report is being generated, you can continue working with the system after submitting the report. The report can be generated either on the same system that you are working or on a separate system.

To generate reports in the background:

Select Tools > Options > Preferences > Reports tab from the menu bar.

 

Set the ’Report generation type’ to ’Report Server’.
When a case is open, even though the report generation option is set to ’Report Server’’ the report will be generated online.

Specifying Language Preferences for Reports

  1. Selecting the Report Languages tab allows you to specify the language in which the report is generated. For each of the Regulatory reports, you can select the language in which it should be printed from the drop-down box.

  1. Select Save to confirm your selection or select Close to cancel the process.

Specifying Preferences for Default Messages

Select the Message tab, to specify the preferences for default messages.

The Message tab contains the check boxes Close AER and When Autocoding. 

Specifying Language Preferences for MedDRA Terms

Select the Language tab, to specify language preferences for MedDRA Terms.

Here you can specify the language for:

 

Select the language from the drop-down list that displays the available languages.  This setting of language is applicable for all further sessions till it is changed again for the current user. The settings for the current user will not affect the settings of other users (All other users of ARISg will continue to use the default settings or their personalized settings).

 

When you change the "ART Dictionary language” in User Preferences, the decodes for the MedDRA terms in Reaction, Disease, Sender Diagnosis and Laboratory records are coded based on the language which is set currently.

 

Codelist: The application considers the languages selected in the Total Safety Configuration Manager, for printing the decodes in MHLW E2B report. This is applicable for ARISg and ARISj applications.

Specifying Preferences for Date Format

  1. Select the Date Format tab, to specify preferences for Date format.

Field Description of Date Format

 

Note: If any of the above values are set in ARISg Administrator, they are considered by default. However the values set in User Preferences will take precedence over the values set in Administrator. The system does not consider the date format entered in User Preferences while generating Overview and AER data reports.

  1. Select Save to confirm your selection or select Close to cancel the process.

Specifying Preferences for Printing Overview Reports

  1. Select the Overview Report tab, to specify the preferences for printing Overview Report.

Field Description of Overview Report tab

  1. Select Save to confirm your selection or select Close to cancel the process.

Subscribing or Unsubscribing Alerts

The Subscribe Alerts menu in the Tools > Alerts menu enables you to subscribe or unsubscribe alerts only if you have ALERTSMANAGER, ALERTSADMIN, OR ALERTSUSER privileges. You can access the Subscribe Alerts menu only when the case is closed.

If the logged in user does not have any of the roles mentioned above, then the application disables the Alerts > Subscribe Alerts menu.  

To subscribe or unsubscribe alerts:

  1. On the Tools menu, in the Alerts group, click Subscribe Alerts.
    The Alert Subscribe/Unsubscribe page appears. By default, the All option is selected and displays the list of all available alerts.

  2. To subscribe, select the required alert and then click  icon.
    The Alert Template Configuration section appears.

  3. Specify the Receiver as Email, Dashboard, or both.

  4. Click Save to save the information.
    The application displays message as “Alert Subscribed Successfully”.

  5. Click OK.
    The alert is subscribed and application displays as Subscribed Alert. This will be listed in the Subscribed Alerts view. This data is saved in the Alerts database.

  6. To unsubscribe, select the required alert and then click icon.
    The application displays message as “Alert Unsubscribed Successfully”.

  7. Click OK.
    The alert is unsubscribed and application displays as Unsubscribed Alert. This will be listed in the No Subscribed Alerts view. This data is saved in the Alerts database.


To search Subscribe or Unsubscribe alerts:

  1. Click Subscribe Alerts option to search for Subscribe alerts.

  2. Click No Subscribed Alerts option to search for unsubscribe alerts.