Clinical Research Associate (CRA)

View the permissions included in the CRA 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 6-3 Permissions included in the CRA 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
  • Update Subject Number after Creation
  • View Blinded Dispensation Details with Calculated Doses [Site]
  • View Blinded Dispensation Details without Calculated Doses [Site]
  • View Classified Subject Data Only
  • View Form Data for Subjects
  • View Queries [Site]

Inventory Management

  • Create Manual Shipments
  • Perform Supplies Reconciliation at Site
  • View Shipments to Sites
  • View Site Inventory

Notifications

  • Receive Notification of Shipments
  • Receive Rule Failure Notification for Locked Data
  • Receive Site has been Updated Notification
  • Receive the Code Break Notification
  • Receive the Dispensation Notification
  • Receive the Pending Signatures Notification
  • Receive the Randomization Notification
  • Receive the Study Limits Notifications
  • Receive the Subject Completion Notification
  • Receive the Subject Number Update Notification
  • Receive the Subject Rollover Notification
  • Receive the Subject Screening Notification
  • Receive the Subject Transferred Notification
  • Receive the Subject Undo Completion Notification
  • Receive the Subject Undo Screen Failure Notification
  • Receive the Subject Undo Withdrawal Notification
  • Receive the Subject Visit Notification
  • Receive the Subject Withdrawal Notification
  • Receive the Unscheduled Visit Notification

Reports

  • Run the Blinded Chain of Custody Report
  • Run the Blinded Inventory Report
  • Run the Blinded Subject Events Dataset
  • Run the Enrollment Report
  • Run the Kit Dispensation Report
  • Run the Kit Reconciliation Report
  • Run the Lab Normal Range Report
  • Run the Order Summary 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 Subject Visit Report
  • Run the Titration Summary Report
  • Run the Training Report
  • Run the User Assignment Report
  • Schedule Reports to Run

Settings

  • Manage Signature Settings

Study Management

  • Answer Assigned Queries
  • Close All Queries
  • Close Auto Queries (planned for a future release)
  • Close Queries By Role (planned for a future release)
  • Create Candidate Queries
  • Create Queries
  • Create Shipments to DDF
  • Delete Candidate Queries
  • Perform Source Data Verification and Reconcile Inventory
  • Transfer subjects between sites
  • Unfreeze subject data entered at a site
  • Verify subject data entered at a site
  • View All Queries

Study Setup

  • Assign a Study Version to a Site
  • Create and Manage SDV Strategies
  • Manage Archives Settings
  • View Depots
  • View Regions
  • View Roles Assignments for Study Users
  • View Sites
  • View Study Design
  • View Study Settings

Trial Management

Note: All permissions listed in this category are planned for a future release.

  • Close Trial Management Events
  • Create Actions on Trial Management Event Records
  • Create Trial Management Event Records
  • Create Unblinded Trial Management Records [Unblind]
  • Edit Actions on Trial Management Event Records
  • Edit Trial Management Event Records
  • Edit Unblinded Trial Management Records [Unblind]
  • Open Trial Management Events
  • View Actions on Trial Management Event Records
  • View Blinded Trial Management Records
  • View Trial Management Event Records
  • View Trial Management Event Records with Actions Assigned to me
  • View Unblinded Trial Management Records [Ublind]

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