Roles for global users in Oracle Clinical One Platform and Oracle Clinical One Digital Gateway

Global users perform administrative tasks, such as creating studies, adding users to studies, managing integrations, and managing training.

Besides the required roles assigned to users in Oracle Life Sciences IAMS, global users must be assigned the appropriate roles to complete their assigned tasks in Oracle Clinical One Platform and Oracle Clinical One Digital Gateway. You can assign one or more of the following roles to global users.

Role Description
Analytics: BI Publisher Authoring.

Provides access to Oracle Business Intelligence (BI) Publisher functionality in the Oracle Analytics Classic View (accessed from the Oracle Clinical One Analytics portal).

Note: Oracle BI Publisher is mainly used to create, edit and manage pixel-perfect reports. See Create a pixel-perfect report.

Analytics: Data Visualizer Authoring
Provides complete authoring access to Oracle Clinical One Analytics, which allows you to:
  • Create and modify reports and dashboards in the Data Visualizer interface .
  • Access Oracle Business Intelligence (BI) Publisher functionality in the Oracle Analytics Classic View.

Note: This role includes the privileges from the Analytics: BI Publisher Authoring role. Users do not need to be assigned with both roles.

Approve Library Kits for Pooled Supplies Allows users to approve and edit kits in a library study, whether the kit has a status of Draft, Approved, or Published.

Assign Site to a Study

Allows to assign sites to studies within the Oracle Clinical One Platform.

Change Library Objects Status

Allows to update the status of an object in an organization's library.

Code List Manager
Allows users to manage code lists in the following ways:
  • Create and manage different types of code lists at a global level (for all studies at your organization):
    • Create new system code lists.
    • Edit existing system default code lists.
    • Create and manage custom code lists.
  • Build reports and visualizations including global-level codelists data when using the Study Codelist Dataset in Oracle Clinical One Analytics.

Coding Integration

Allows to configure and manage an integration between the Oracle Clinical One Platform and Oracle Central Coding

Create Study Roles for your Organization

Allows to create study roles that are available for all studies at an organization level.

Typically, this role may be assigned to someone who performs standard study design tasks.

Create and Edit Library Kits for Pool Supplies

Allows to create and edit kits (including pooled kits) in a library study, only in Draft mode.

DMW Integration

Allows to manage the integration of Oracle Life Sciences Data Management Workbench with Oracle Clinical One Platform.

Note: Users with this permission must also ensure production data is appropriately synchronized between Oracle Clinical One Platform and Oracle DMW.

DataHubInternal

This role is typically assigned to internal Oracle users who configure integrations with Oracle Clinical One Analytics.

Note: This is a global role internal to Oracle, which should not be associated with external global users.

Delete Library Kits Allows user to delete kits from a library study.

Global User Manager

Provisions users to add and manage global users and their roles. This user also has the capability to add users to a study and to manage training requirements for the entire organization.

Note: This user does not have access to individual sites in the studies. If the user is responsible for assigning other users to sites, they must also be assigned site and user administrator role at the study level, and be assigned to all sites and depots that they need to associate other users with. See Best practices for role, site, and depot assignment.

Intake Designer

Designs and configures Recipes required to process incoming Release Assessment Environment (RAE) documents, to extract data within Oracle Safety One Intake.

Intake Integration

Enables the Oracle Safety One Intake business service to integrate data with external systems.

Note: This role is only for API Integration users.

Intake Processing

Provisions Oracle Life Sciences Safety One Intake Cloud Service users who process RAE documents.

Note: This role is only for the Oracle Safety One Intake business service.

Intake Service User

Provisions Oracle Safety One Intake users who execute the background services necessary for processing RAE documents.

Note: This role is only for users of the Oracle Safety One Intake business background service.

Intake View Only

Provides read-only access to Oracle Safety One Intake users. Can be used to provision restrictive access to support users.

Integration Builder

This is an Oracle internal role and should not be assigned to external users.

Integration Developer

This is an Oracle internal role and should not be assigned to external users.

Integration Manager

Allows user to configure integration templates and monitor integrations once they are live.

Caution: Error messages for failed jobs may contain potentially unblinding data. Do not assign this role to blinded study users.

Integration Viewer

Provisions users with read-only access to all Oracle Clinical One Digital Gateway areas, mainly for monitoring purposes.

Manage Contacts and Organizations

Allows users to manage contacts and organizations at the global level. This allows to create sites to be used in all your organization studies. Users with this role also have the ability to transfer organizations and contacts associated with active studies.

Manage Library Objects
Allows a library user to manage an object within the library, such as:
  • Edit objects' attributes.
  • Update objects' details in a library study.
  • Update objects' status.

Oracle Admin

This is an Oracle internal role and should not be assigned to external users.

Service Account

This is an Oracle internal role and should not be assigned to external users.

Study Creator

Provisions users to create studies, manage global users and assign roles to users in Oracle Clinical One Platform studies.

Users with the Study Creator role are the only ones who can assign study roles for users in the study design mode. Study design roles include:
  • Study designer
  • User administrator
  • View study design

Note: This user does not have access to individual sites in the studies. If the user is responsible for assigning other users to sites, they must also be assigned site and user administrator role at the study level, and be assigned to all sites and depots that they need to associate other users with. See Best practices for role, site, and depot assignment.

Training Administrator

Allows user to create training studies and assign training managers across Oracle Life Sciences products:
  • Oracle InForm
  • Oracle Central Designer
  • Oracle Central Coding
  • Oracle InForm User Management Tool
  • Oracle IRT

Note: Only assign this role to users using Oracle Health Sciences Learn Manager.

Training Manager

Allows to assign training to other users, review training completion status, run reports for assigned and complete training, and send reminders across the following Oracle Life Sciences products:
  • Oracle InForm
  • Oracle Central Designer
  • Oracle Central Coding
  • Oracle InForm User Management Tool
  • Oracle IRT

Note: Only assign this role to users using Oracle Health Sciences Learn Manager.

View Contacts and Organizations

Provisions users with read-only access for global-level contacts and organizations used across all studies in the organization.

View Library Objects

Provisions users with read-only access to objects in an organization's library. Users with read-only access cannot edit or manage library objects.