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 Health 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 Notes

Assign Site to a Study

Assigns sites to studies within the Oracle Clinical One Platform.

Planned for a future release.
N/A
Code List Manager
  • Creates study roles that are available at an organization level. These study roles are populated in each of your studies when the study is created.
  • Creates and manages different types of code lists at a global level (for all studies at your organization): creates new system code lists, edits existing system default code lists, creates and manages custom code lists.
This role may be assigned to users at a sponsor or CRO in order for them to create and manage code lists for all studies at their organization.

Coding Integration

Configures and manages an integration between the Oracle Clinical One Platform and Oracle Central Coding

N/A

Create Study Roles for your Organization

Creates study roles that are available at an organization-level.

Typically, this role may be assigned to someone who performs standard study design tasks and can also create organization-level study roles.

DataHubInternal

A global role internal to Oracle, which should not be associated with external global users. This role is typically assigned to internal Oracle users who configure integrations with Oracle Clinical One Analytics.

N/A

DMW Integration

Manages the integration of Oracle Health Sciences Data Management Workbench with Oracle Clinical One Platform.

N/A

Global User Manager

Adds users to a study and assigns all roles, including global users. Manages the training requirements for your organization.

If the user is responsible for assigning other users to sites, the user must also be a site and user manager, and be assigned to all sites and depots that they have to associate users with. See Best practices for role, site, and depot assignment for more information.

Intake Designer

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

N/A

Intake Integration

Integrates data with external systems from the Oracle Safety One Intake business service.

A role only for API Integration users.

Intake Processing

A Oracle Health Sciences Safety One Intake Cloud Service user who processes Release Assessment Environment documents.

A role for the Oracle Safety One Intake business service only.

Intake Service User

A Oracle Safety One Intake user who executes the background services necessary for processing Release Assessment Environment documents.

A role for Oracle Safety One Intakebusiness background service users only.

Intake View Only

A Oracle Safety One Intake user who provides read-only access to support users.

Can be used to provision restrictive access to support users.

Integration Builder

Create and manage new integration types between Oracle Clinical One Platform and other applications using the integration builder in Oracle Clinical One Digital Gateway.

This role is assigned along with the Integration Manager global role, to let users sign in Oracle Clinical One Digital Gateway.

The Integration Builder role allows the user to create and manage new integration types using the integration builder functionality.

Integration Manager

Integrates Oracle Clinical One Platform with another application using Oracle Clinical One Digital Gateway.

This role includes the complete set of permissions for Oracle Clinical One Integration Hub and allows the user to:

  • Access Oracle Clinical One Digital Gateway.
  • Use all of its features to create, configure, update, monitor, and troubleshoot integrations.
  • Make calls to the Oracle Clinical One Digital Gateway APIs.

Error messages may reveal integration data that can potentially be unblinding. The users who review error messages should not be blinded members of the study team.

Integration Viewer

Views integrations and settings in Oracle Clinical One Digital Gateway. This view-only role allows the user to:

  • Access Oracle Clinical One Digital Gateway.
  • View all existing integrations and settings, including current status or setup.
  • Download integration file templates and integration files for existing integrations.

Users with this role can't make any changes in Oracle Clinical One Digital Gateway, meaning that they can't manage settings, integrations, or integration jobs.

Manage Contacts and Organizations

Manage contacts and organizations to create your sites in Oracle Clinical One Platform.

Planned for a future release.

N/A

Oracle Admin

A global role internal to Oracle, which should not be associated with external global users.

N/A

Service Account

A global role internal to Oracle, which should not be associated with external global users.

N/A

Study Creator

Creates studies, manages global users and assigns roles to users in Oracle Clinical One studies. This user does not have access to individual sites in the studies. You must assign User and Site Manager roles in the study.

The only users who can assign study design roles are global users with the Study Creator role. Study design roles include:
  • Study designer
  • User administrator
  • View study design

If the user is also responsible for assigning other users to sites and depots, the user must be added to the study as a site and user administrator, and be assigned to all sites and depots that they have to associate users with. See Best practices for role, site, and depot assignment for more information.

Training Administrator

Creates training studies for and assign training managers across Oracle Health Sciences products:
  • Oracle InForm
  • Oracle Central Designer
  • Oracle Central Coding
  • Oracle InForm User Management Tool
  • Oracle IRT

You need to assign this role to users only if you're using Oracle Health Sciences Learn Manager to create training studies for all previously mentioned products.

Training Manager

Assigns training to users and sends reminders across Oracle Health Sciences products:
  • Oracle InForm
  • Oracle Central Designer
  • Oracle Central Coding
  • Oracle InForm User Management Tool
  • Oracle IRT

Checks the training that a user has completed and runs reports for assigned and completed training.

You need to assign this role to users only if you're using Oracle Health Sciences Learn Manager to create training studies for all previously mentioned products.

View Contacts and Organizations

Manages contacts and organizations to create your sites in Oracle Clinical One.

Planned for a future release.

N/A