Study Manager

View the permissions included in the Study Manager template study role. This template study role is of Sponsor type and 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 template study roles.

Table 6-15 Permissions included in the Study Manager template study role

Category Assigned permissions

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

  • Edit Classified Subject Data Only
  • View Blinded Dispensation Details with Calculated Doses [Site]
  • View Blinded Dispensation Details without Calculated Doses [Site]
  • View Classified Subject Data Only
  • View Queries [Site]

Inventory Management

  • Create Manual Shipments
  • View Shipments to Sites
  • View Site Inventory

Notifications

  • Receive Site has been Updated Notification
  • Receive the Code Break Notification
  • Receive the Study Limits Notification
  • Receive the Subject Transferred Notification,

Reports

  • Run the Blinded Chain of Custody Report
  • Run the Blinded Kits Dataset
  • Run the Blinded Randomization Report
  • Run the Blinded Subject Events Dataset
  • Run the Enrollment Report
  • Run the Kit Dispensation Report
  • Run the Site and Depot Report
  • Run the Study Codelist Dataset
  • Run the Study Design Report
  • Run the Study Query Dataset
  • Run the Subject Data Report
  • Run the Subject Dataset
  • Run the Subject Events Report
  • Run the Subject Form Items Dataset
  • Run the Subject Forms Dataset
  • Run the Subject Query Report
  • Run the Training Report
  • Run the User Assignment Report
  • Schedule Reports to Run
Settings
  • Edit Welcome Details in General Study Settings
  • Manage Signature Settings

Study Management

  • Transfer Subjects Between Sites

Study Setup

  • Assign a Study Version to a Site
  • Create and Manage SDV Strategies
  • Edit General Study Settings
  • Edit Regions
  • Edit Study Settings
  • Manage Archives Settings
  • Move a Study Design to Testing or Production
  • View Depots
  • View Regions
  • View Role Assignments for Study Users
  • View Sites
  • View Study Design
  • View Study Settings

For more information on each of these permissions, see Descriptions of permissions in Oracle Clinical One Platform.