Clinical Research Associate (CRA)

View the permissions included in the CRA 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.

Table 8-3 Permissions included in the CRA 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

  • Edit Classified Subject Data Only
  • Update Subject Number after Creation
  • View Blinded Dispensation Details with Calculated Doses
  • View Blinded Dispensation Details without Calculated Doses
  • View Classified Subject Data Only
  • View Form Data for Subjects
  • View Queries

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 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 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
  • Close Queries By Role
  • 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)