Oracle® Argus Safety

Creating a New Case

1. On the Home page, hover over the Case Actions menu and click New.

   
   

2. On the Initial Case Entry page, enter the mandatory information (fields with a red flag) and click Continue.

3. On the BookIn screen, check the applicable checkboxes and click BookIn.

4. If Argus has been configured to generate a case number automatically, it is generated now.

   If the case number is not automatically generated, enter it according to your company guidelines.

5. When the case creation message appears, click Yes.

   Note: If you click Yes, the Case Form page appears. You can now enter case data.

   If you click No, the case is saved and closed. You can open the case and enter data at any time.

For more information, see Creating a New Case in the Oracle Argus Safety User's Guide.

Finding an Existing Case

1. On the Home page, hover over the Case Actions menu and click Open.

   
   

2. On the Case Search Criteria page, select the applicable search criteria and click Search.

3. When the system displays the search results, locate the case in the list.

4. Click the link associated with the Case ID to open that case in the Case Form.

For more information, see Finding and Opening Existing Cases of the Oracle Argus Safety User's Guide.

Updating a Case

• Case data is organized on four tabs: General, Patient, Products, and Events.

• These tabs have sub-tabs and sections that further organize the information collected. Use the button on the right side of the screen to minimize or maximize each section.

• Tabbing from field to field activates any auto-calculated fields.

• When you finish entering information for a section, tab, or sub-tab, click the Save icon at the top of the page.

  
  

See the following sections for information on using the tabs.

Entering General Data

For basic information on using the General tab, see General Tab in the Oracle Argus Safety User's Guide.

For details on entering data in each section of the General tab, see:

• General Information

• Study Information

• Reporter Information

• Literature Information

Entering Patient Data

For general information on entering Patient data, see Patient Tab in the Oracle Argus Safety User's Guide.

The Patient tab has two sub-tabs.

• Patient Tab

• Parent Tab

Patient Tab

For details on entering data in each section of the Patient tab, see:

• Patient Information

• Patient Details

• Event Death Details

• Other Relevant History

• Lab Data

• Relevant Tests

Parent Tab

For details on entering data in each section of the Parent tab, see:

• Parent Information

Entering Products Data

For general information on entering Products data, see Products Tab in the Oracle Argus Safety User's Guide.

The Products tab has the following sub-tabs:

• Drug Tab

• Device Tab

• Vaccine Tab

Drug Tab

For details on entering data in each section of the Drug tab, see:

• Product Information

• Product Indication

• Quality Control

• Dosage Regimens

• Product Details

Device Tab

For details on entering data in each section of the Device tab, see:

• Product Information

• Product Indication

• Device Information

• Quality Control

Vaccine Tab

For details on entering data in each section of the Vaccine tab, see:

• Product Information

• Product Details

• Vaccine Administration

• Prior Adverse Events

• Vaccine History

Entering Events Data

For general information on entering Events data, see Events Tab in the Oracle Argus Safety User's Guide.

The Events tab has the following sub-tabs:

• Event Tab

• Event Assessment Tab

Event Tab

For details on entering data in each section of the Event tab, see:

• Event Information

• Event Coding

• Seriousness Criteria

• Nature of Event

Event Assessment Tab

For details on entering data in each section of the Event Assessment tab, see:

• Event Assessment Tab

Viewing Updates made to your Case

1. Open an existing case, hover over the Case Actions menu and click Case Revisions.

2. On the Argus Safety Case Details dialog box screen, click Revisions.

3. From the Revision History, click on a specific revision to view the changes made.

   
   

Attaching Additional Information to your Case

1. On the Case Form page, click the Additional Information tab.

   
   

2. Enter information in the Notes and Attachments and References sections.

For basic information on using the Additional Information tab, see Additional Information Tab in the Oracle Argus Safety User's Guide.

Viewing New Cases in the Worklist

1. On the Home page, hover over the Worklist menu and click New.

   
   

2. On the New page, enter the required information and click Search.

For details on entering data in each section of the New page, see:

• Filtering Functions

• Total Number of Rows

Note: Once you have accepted the case, it is Open.

Finding a Case Assigned to you

1. On the Home/Personal Argus Status page, check the Cases Assigned checkbox.

   The list of cases assigned to you is displayed.

   
   

For more information, see Case Workload in the Oracle Argus Safety User's Guide.

If the Personal Argus Status Page is not your default home page, go to Utilities and click Personal Argus Status.

Viewing your Pending Action Items

1. On the Home/Personal Argus Status page, check the Action Item Entries checkbox.

   The list of your pending action items is displayed.

   
   

For more information, see Personal Argus Status in the Oracle Argus Safety User's Guide.

Viewing your Worklist Action Items

1. On the Home page, hover over the Worklist menu and click Action Items.

   
   

2. On the Action Items page, enter the required information and click Search.

3. Click Print List.

For more information, see Action Items in the Oracle Argus Safety User's Guide.

Viewing your Coding Action Items

1. On the Home page, hover over the Worklist menu and click Coding Action Items.

   
   

2. On the Coding Action Items page, enter the required information and click Search.

3. Click Print List.

For more information, see Coding Action Items in the Oracle Argus Safety User's Guide.

Performing a Medical Review

• When you finish entering information for a section, tab, or sub-tab, click the Save icon at the top of the page.

Reviewing Case Narrative

For basic information on using the Analysis tab, see Analysis Tab in the Oracle Argus Safety User's Guide.

For details on reviewing and entering data in each section of the Analysis tab, see:

• Case Analysis

• Case Summary

Reviewing MedWatch Information

For details on reviewing and entering data in each section of the MedWatch Info tab, see:

• MedWatch Info Tab

Reviewing BfArM Information

For details on reviewing and entering data in each section of the BfArM tab, see:

• BfArM Info Tab

Reviewing AFSSaPS Information

For details on reviewing and entering data in each section of the AFSSaPS tab, see:

• AFSSaPS Info Tab

Scheduling an Expedited Report

1. Open the case for which you want to schedule a report.

2. On the Case Form page, click the Regulatory Reports tab.

3. On the Regulatory Reports page, click Schedule New Report.

   
   

4. On the Schedule New Expedited Report page, enter the required information and click OK.

5. Click the Save icon at the top of the page.

For details on using Scheduling Reports, see Scheduling Reports in the Argus Safety User's Guide.

Note: This section also contains instructions for Auto-scheduling Reports.

Reviewing a Draft Report

1. Open the case for which you want to schedule a report.

   Note: You can only view a Draft report if the relevant case is unlocked.

2. On the Case Form page, click the Regulatory Reports tab.

3. From the Total Number of Rows tab, locate the relevant report and click Draft to view the report.

For details on viewing and generating Reports, see Generating Reports in the Argus Safety User's Guide.

Generating an Expedited Report

1. Open the case for which you want to schedule a report.

   Note: Verify that the relevant case has been locked and the required report has been scheduled.

2. On the Case Form page, click the Regulatory Reports tab.

3. From the Total Number of Rows tab, locate the relevant report and click Final to generate the report.

For details on using Generating Reports, see Generating Reports in the Oracle Argus Safety User's Guide.

Transmitting a Report

1. On the Case Form page, click the Reports tab, then select Compliance, and then Periodic.

2. On the Periodic Reports page, locate the relevant report and click on the Status of the report.

3. On the Report Details page, click Transmission and then click Transmit.

4. On the Transmit to Recipients page, enter the required information and click Transmit.

You can also transmit several reports together using the Bulk Transmit option.

1. On the Home page, hover over the Worklist menu and click Bulk Transmit.

2. On the Bulk Transmit page, enter the required information and click Search.

For details on entering data in each section of the Search Case page, see:

• Total Number of Rows

• User Options

• Routing Details

Tracking your ICSR Report Submissions

1. On the Home page, hover over the Worklist menu and click Bulk ICSR Transmit.

   For general information on tracking your submissions, see Bulk ICSR Transmit in the Oracle Argus Safety User's Guide.

2. The Bulk ICSR Transmit screen has the following sub-tabs:

   • Reports Tab

   • Messages Tab

Reports Tab

For details about the sections and user options on the Reports tab, see:

• Reports Tab

• Total Number of Rows

• Reports Tab User Options

Messages Tab

For details about the sections and user options of the Messages tab, see:

• Messages Tab

• Search Criteria

• Total Number of Rows

• Message Tab User Options

Finding an Overdue Report

1. On the Home page, hover over the Worklist menu and click Reports.

2. Click on the field Days Past Due on the right of the Total Number of Rows and if needed click again to show Days Past Due in descending order (arrow pointing downwards).

   
   

3. To view all reports select ALL at top right of the screen.

4. Click the Search button, at the top left of the screen. Overdue cases are all those reports shown as greater than 0 Days Past Due and greater than today's date.

   
   

For details on entering data in each section of the Total Number of Rows tab, see Total Number of Rows.