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
Assign Site to a Study	Assigns sites to studies within the Oracle Clinical One Platform.
Change Library Objects Status	Updates the status of an object in an organization's library.
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. Builds reports and visualizations using the Tenant Codelists Dataset in Oracle Clinical One Analytics. Note: 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
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.
DMW Integration	Manages 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.
Global User Manager	Adds users to a study and assigns all roles, including global users, and manages the training requirements for your organization. Note: 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.
Intake Integration	Integrates data with external systems from the Oracle Safety One Intake business service. Note: This role is only for API Integration users.
Intake Processing	A Oracle Life Sciences Safety One Intake Cloud Service user who processes Release Assessment Environment documents. Note: This role is only for the Oracle Safety One Intake business service.
Intake Service User	A Oracle Safety One Intake user who executes the background services necessary for processing Release Assessment Environment documents. Note: This role is only for users of the Oracle Safety One Intake business background service.
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	This Oracle internal role should not be assigned to your users even though it is visible in the Oracle Clinical One Platform user interface.
Integration Developer	This Oracle internal role should not be assigned to your users even though it is visible in the Oracle Clinical One Platform user interface.
Integration Manager	Configures integration templates and monitors integrations once they are live. Note: Error messages for failed jobs may contain integrated data that could be unblinding. Users who can review error messages should not be blinded study users.
Integration Viewer	This role grants users read-only access to all Oracle Clinical One Digital Gateway areas, mainly for monitoring purposes.
Create and Edit Library Kits for Pool Supplies	Creates and edits kits (including pooled kits) in a library study only in Draft mode.
Approve Library Kits for Pooled Supplies	Approves and edits kits in a library study whether the kit has a status of Draft, Approved, or Published.
Delete Library Kits	Deletes kits from a library study.
Manage Contacts and Organizations	Manage contacts and organizations to create your sites in Oracle Clinical One Platform. 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 editing an object's attributes, updating its details in a library study, or updating an object's status.
Oracle Admin	A global role internal to Oracle, which should not be associated with external global users.
Service Account	A global role internal to Oracle, which should not be associated with external global users.
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 Life Sciences products: Oracle InForm Oracle Central Designer Oracle Central Coding Oracle InForm User Management Tool Oracle IRT Note: 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 Life 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. Note: 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 Platform.
View Library Objects	Views objects in an organization's library without the ability to edit or manage them.