Adding User Groups

This section enables the Administrator to configure the security levels for each work group.

Radio buttons enable you to view the group and assign access rights for several specific sections of the case form, menu, case workflow, and report workflow.

If a user belongs to multiple groups, the access rights for the user will be the sum-total of the individual group access rights. Consider the following example:

John Smith is an Oracle Argus Safety User and his profile has been added to 2 user groups with different access level permissions for each group.

• John has access rights to the Patient Tab in one group and access rights to the General Tab in another group.
• In this case, John will be able to access both the Patient and the General tabs of Oracle Argus Safety.

Use the following procedure to create a user group

1. Click Access Management > Argus > Groups.
2. Select the filtering criterion to display the list of Groups or Users in the left panel.
3. Select a Group and click to view the group details in the right panel.
   
   

   

   
   

   Tip:

   • You can alternatively click Add Group to create a new group.
   • Use Copy to make an editable copy of an existing group.
   • Use Delete to delete a group.
4. Enter the Group Name. This should be a unique name associated with this Group.
5. Enter the Email address, if applicable.
6. Enter the Supervisor Email address, if applicable.
7. In the Case Form section, select the desired access right option (Modify, View, or No Access) for the group's access to each of the listed items of Case Form.

   Note:

   The following fields are required in order to save a case: Initial Receipt Date, Country of Incidence, Report Type, Suspect Product, and Event Description as Reported. Therefore, the group responsible for initial case entry must have access to these fields in order to save new cases.

   The following user group accesses have been renamed:

   • Case Patient – Personal Patient Information has been renamed as Case Patient - Patient Information.
   • Case Patient – Patient Information has been renamed as Case Patient – Patient Details.
8. In the Menus section, enable or disable access of the group, to particular items in the Oracle Argus Safety menu.

   Tip:

   Refer to the Oracle Argus Safety User's Guide for information about the functions of the Case Form sections and the menu items in the Oracle Argus Safety user interface.
9. In the Listedness Determination section, select a list of countries. This enables the end user to override the listedness determination in the Event Assessment section of the Case Form for product licenses that match the countries selected in this step.
10. In the Advanced Conditions section, select No Access to Create Advanced Condition, No Access to Share Advanced Conditions, and/or No Access to View and Edit SQL.

    Note:

    Only trusted users should be given access to Advanced Conditions. This is because users who have this access will have complete access to the information in the Argus Schema.

    Tip:

    • If you select No Access to Create Advanced Condition, Advanced Conditions does not appear as an option for that user group.

    • If you select No Access to Share Advanced Conditions, the user group does not have access to share Advanced Conditions.

    • If you select No Access to View and Edit SQL, the SQL... button will not appear as an option for that user group.

11. In the Restrictions section, select Products.
12. Click Add Product, to open the Available Products dialog box.
13. Select each product you want to add and click OK.

    
    
    

14. In the Restrictions section, select Study.
15. Click Add Study, to open the Available Studies dialog box.
16. Click the appropriate checkboxes to select the required studies and click OK.
    
    

    

    
    
17. Click OK to save the group.

Groups Included with the Factory Data

The following table lists and describes the groups included with the factory data.

Group	Description
Administrator	This group has access rights to all areas and all the functionality of Oracle Argus Safety.
Investigator	Receives an e-mail alert that can be set up during Clinical Study Configuration.

About Filtering Criterion

The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section.

Using Organized by

The system displays the filtering browser in the top-left corner of the left panel. You can filter based on either of the two combination shown in the following illustration.

Consider the following.

• If you enable Organized by Groups, the generated output displays in a tree-format in the left panel. The structure is based on the entire categorization of Groups and Users
• If you enable the Organized by Users, only the User list is available in the tree view in the left panel.

Using contains or starts with enables you to specify whether your search should contain or start with specific alphabetic characters. For example, filtering criterion shown in the following illustration enables the system to for all Groups that contain the word "administrator."