How user permissions work

View Raw Safety Database

·        Drill down to view case details.

You grant this permission to most users.

To save queries to the Query Library, a user must also have the Create Queries/Case Series permission.

Download Raw Data

·        Download case series details and data for results graphs.

View Data Mining Results

·        View results of data mining runs.

·        Create, edit, and delete saved lists.

Create Data Mining Run

·        Create and re-run data mining runs.

·        Rename, cancel, and delete data mining runs that you create.

·        View jobs for data mining runs.

·        Create queries to add a database restriction or custom terms to a data mining run.

Save Intermediate Files

·        Save intermediate data files created during data mining runs.

Delete Any Run

·        Cancel and delete published or unpublished data mining runs created by users in your login group.

View Topics

·        View topics on the Topics page.

If the user is a member of a work team, the user must also have work team permissions.

Work team permissions determine the level of access that a user has to topics. For example, work team permissions determine whether a user can view topics, edit topics and topic actions, edit attachments, and so on.

View Topics across Work Teams

·        View all topics that are visible to any of the work teams in that user's login group.

·        View topics, topic actions, and attachments without membership in a work team or work team permissions.

A user must also have the View Topics permission.

Hide Queries/Case Series/Report pages

·        Users with this permission cannot view the Queries, Case Series, and Report pages, regardless of their other permissions.

View Drug Profiles

·        View drug profiles on the Drug Profile page.

Create Drug Profile Layouts

·        Create, edit, and manage drug profile layouts on the Drug Profile page.

A user must also have the View Drug Profile permission.

Create Queries/Case Series

·        Transfer cases to an existing case series.

To create, copy, edit, rename, and delete queries and case series, a user must also have the View Raw Safety Database permission.

Create Report Definitions

·        Create, copy, edit, and delete report definitions.

All users can run report definitions.

Create Report Outputs

·        Create, edit, copy, and delete report outputs.

All users can view report outputs.

BI Consumer        

·        View Oracle Business Intelligence (BI) Enterprise Edition (EE) Topics reports.

The BI Consumer permission in Empirica Signal corresponds to the BI Consumer role in Oracle BI EE.

You must implement the Oracle BI EE Topics reporting feature to enable this permission.

BI Author

·        Perform activities that correspond to the BI Author role in Oracle BI EE.

You must implement the Oracle BI EE Topics reporting feature to enable this permission.

BI Administrator

·        Perform activities that correspond to the BI Administrator role in Oracle BI EE.

You must implement the Oracle BI EE Topics reporting feature to enable this permission.

View Signal Management

·        Perform all activities on the Signal Review page except activities that also require Manage Signal Views, Manage Signaling Terms, or Manage Signal Configurations permissions.

Users can always manage signal views that they have created.

Manage Signal Views

·        Manage signal views created by users in your login group.

A user must also have the View Signal Management permission.

Manage Signaling Terms

·        Add, edit, and delete products and product-event combinations.

·        Assign products and product-event combinations to reviewers.

For interactive signal configurations only:

·        Rename products.

·        Manage designated medical events, custom terms, targeted medical events, and listed events for interactive signal configurations.

A user must also have the View Signal Management permission.

Manage Signal Configurations

·        View and edit existing signal configurations.

·        For interactive signal configurations only, refresh signal configurations.

To assign signal configurations to login groups, a user must also have the Administer Users permission.

Administer Users

·        View and edit user names, user profiles, and work teams in your login group.

·        For self-hosted installations only, add user names, user profiles, and work teams in your login group.

·        Update user information from LDAP.

·        Send a message to users in the same login group.

·        Arrange table columns and set the column layout as the default for your login group.

·        View the User Activity Audit Trail for users in the same login group.

·        View currently logged in users in the same login group.

Users with this permission cannot create or delete login groups.

For some activities, users with this permission can act on objects (including unpublished objects) created by users in the same login group.

Users with the Administer Users permission see the following activities performed by the system, irrespective of login group:

·        Users: Create User or Profile

·        Users: Edit User or Profile

·        Users: Delete User or Profile

Administer LDAP

·        Import LDAP users.

·        Refresh LDAP users.

·        Change LDAP/Local authentication.

Administer Drug Profiles

·        Create and manage drug profile configurations.

A user must also have the View Drug Profile Layouts permission.

Manage Configurations

·        View data configurations.

·        Create, import, copy, validate, and edit a data configuration for which you have the Edit permission.

·        Delete a data configuration that does not have runs, case series, saved lists, report definitions, or report outputs associated with it.

Manage Topic Workflow Configurations

·        Create and manage topic workflow configurations.

A user must also have:

·        The View Topics permission.

·        The Administer Users permission to assign the configuration to a login group or define permissions for work team members.

Manage Aliases

·        Add, edit, and delete aliases.