Roles for unblinded study users

Learn more about the roles and responsibilities of an unblinded study user, such as a clinical supply manager or statistician.

About these study roles

  • Modes: You can assign these study roles in Testing, Training, and Production mode.
  • Users: You typically assign these study roles to an unblinded study team member, such as a clinical supply manager, statistician, or unblinded depot user.
  • Type: These study roles fall under the Sponsor category.

Unblinded study team member roles and their responsibilities

Role Responsibilities Notes

Clinical supply manager

For the template role description, see Clinical Supply Manager.

  • View data, create and manage resupply strategies, as well as create and manage depots.
  • Run reports.
  • Create custom reports and visualizations in Oracle Clinical One Analytics
  • Perform other study setup tasks such as assigning a resupply strategy to a site, creating and managing sites, editing regions, or viewing role assignments for study users.

None.

Production admin

For the template role description, see Production Admin.

  • Assist your organization, as needed, throughout the study process or study conduct period.
  • Create custom reports and visualizations in Oracle Clinical One Analytics
  • Edit the custom welcome letter content.

None.

ODM Extract

For the template role description, see ODM Extract.

Extract several types of data in an ODM-XML format:
  • Administrative data
  • Clinical data
  • Metadata

None.

Rule designer

For the template role description, see Rules Designer.

  • Design, test, approve, and publish rules in a study.
  • Create custom reports and visualizations in Oracle Clinical One Analytics
  • Edit the custom welcome letter content.

None.

Statistician

For the template role description, see Statistician.

  • View data and manage randomization lists.
  • Create custom reports and visualizations in Oracle Clinical One Analytics
  • Perform other study setup and study management tasks such as editing regions, uploading and generating inventory lists, viewing unblinded pharmacist kits, and performing a code break.

None.

Unblinded depot user

For the template role description, see Unblinded Depot User.

  • View data and manage shipments at a depot.

None.

View only for Unblinded Support Users

For the template role description, see View Only for Unblinded Support Users.

  • View details about a study to assist with troubleshooting and integrations, as needed.
  • Create custom reports and visualizations in Oracle Clinical One Analytics

None.