Tracking Status Accruals for Clinical Subjects of Sites
This task describes how to track the progress of subject status accruals for a clinical site by creating a real-time snapshot of the current subject status accruals for the site. The CRA (clinical research associate) can use the snapshot to verify the subject status data that an end user manually records during a site visit.
To track status accruals for clinical subjects of a site
Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track the status accruals for subjects.
The Trip Report form for the selected site visit appears.
Navigate to the Summary view.
Click Capture in the Subject Status Snapshot applet to generate a real-time snapshot of the status accruals for clinical subjects.
Some fields are described in the following table.
Field
Comments
Visit Type
Displays the type of clinical visit. The following clinical visit types are preconfigured:
Screening
Rescreening
Enrollment
End of Study
Subject Status
Displays the subject status. The following subject visit statuses are preconfigured:
Screened
Screen Failure
Randomized
Enrolled
Completed
Early Terminated
Re-screened
Withdrawn
Total Accrual Number
Displays the number of current and past subject status accruals that are automatically created for the site visit.
Total Actual Number
Type the number of current and past subject status accruals that you manually recorded during the site visit.
Current Accrual Number
Displays the number of current subject status accruals that are automatically created for the site visit.
Current Actual Number
Type the number of current subject status accruals the you manually recorded during the site visit.
Comments
Type a description of any discrepancy between accrual numbers and actual numbers.
Reviewer Comments
Type reviewer comments about the trip report. Only the assigned reviewer can modify this field.
Time Stamp
Displays the date and time that the snapshot is generated.