Data Manager

View the permissions included in the Data Manager template study role. This template study role is available for all studies at your organization.

Note:

You should always copy a template role and begin customizing it within the context of your study. For more information, see About predefined study roles.
A user who is assigned this template study role template can also manage tasks related to integrations between Oracle Clinical One Platform and:
  • A third-party electronic data capture system
  • Oracle Life Sciences InForm
  • Veeva Vault CTMS
  • Oracle Siebel Clinical Trial Management System

Table 8-5 Permissions included in the Data Manager template study role

Category Permissions assigned

CRF Submit Access

  • Run and Download Site Confirmation and Download Log Audit Reports
  • Run and Download all PDF Request Types and Audit Reports. Enable Share with Sites, and Site Confirmation

Clinical Data Collection

  • Add a Lab to a Site
  • Add and Update Lab Normal Ranges
  • Create and Add Labs to a Site
  • Edit Classified Subject Data Only

    Note: When a data manager is assigned this permission, they may notice that they have the ability to edit forms that don't contain classified data. Advise data managers to only work with the forms that contain classified data.

  • View Classified Subject Data Only
  • View Form Data for Subjects
  • View Queries

Data Extract

  • Run the Subject Data Extract (Unblind)

Notifications

  • Receive the Code Break Notification
  • Receive the Pending Signatures Notification
  • Receive the Study Limits Notifications
  • Receive the Subject Completion Notification
  • Receive the Subject Rollover Notification

Reports

  • Run the Blinded Chain of Custody Report
  • Run the Blinded Randomization Report
  • Run the Blinded Subject Events Dataset
  • Run the Kit Dispensation Report
  • Run the Kits and Randomization Design Dataset
  • Run the Study Codelist Dataset
  • Run the Study Design Report
  • Run the Study Query Dataset
  • Run the Subject Data Report
  • Run the Subject Data for CTMS Report
  • Run the Subject Events Report
  • Run the Subject Form Items Dataset
  • Run the Subject Forms Dataset
  • Run the Subject Query Report
  • Schedule Reports to Run

Settings

  • Manage Signature Settings

Study Management

  • Close All Queries
  • Close Auto Queries
  • Close Queries By Role
  • Create Candidate Queries
  • Create Queries
  • Delete Candidate Queries
  • Freeze subject data entered at a site
  • Lock subject data entered at a site
  • Unfreeze subject data entered at a site
  • View All Queries

Study Setup

  • View Role Assignments for Study Users
  • View Study Design
  • View Subject Settings