Clinical Research Associate (CRA)

This topic describes the permissions included in the CRA (template) study role in the application. This template study role is available for all studies in your organization. You can copy the study role and customize it for each individual study you work in.

Note:

To see an overview of all permissions that can be included in study roles, see the View Permissions window in the application.

Table 8-2 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
  • Unfreeze subject data entered at a site
  • Verify subject data entered at a site
  • 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 Site has been Updated Notification
  • Receive the Code Break Notification
  • Receive the Dispensation Notification
  • Receive the Randomization Notification
  • Receive the Rule Failure Notification for Locked Data
  • Receive the Study Limits Notifications
  • Receive the Subject Completion 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

  • Schedule Reports to Run
  • 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 (planned for a future release)
  • Run the Study Design Report
  • Run the Study Query Dataset
  • Run the Rules Report
  • 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

Study Management

  • Answer Assigned Queries
  • Close Queries
  • Create Candidate Queries
  • Create Queries
  • Create Shipments to DDF
  • Delete Candidate Queries
  • Perform Source Data Verification and Reconcile Inventory
  • Transfer subjects between sites
  • View All Queries

Study Setup

  • Assign a Study Version to a Site
  • View Depots
  • View Regions
  • View Roles Assignments for Study Users
  • View Sites
  • View Study Design
  • View Study Settings