Siebel Clinical Trial Management System Guide > Administering and Using Clinical Trip Reports >

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 is manually recorded during a site visit.

To track status accruals for clinical subjects of a site

  1. Navigate to the Site Visits screen, then the Clinical Site Visits List view.
  2. 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.

  3. Navigate to the Summary view.
  4. Click Capture in the Subject Status Snapshot applet to generate a real-time snapshot of subject status accruals.

    Some fields are described in the following table.

    Field
    Read-Only
    Comments

    Accruals Number

    Yes

    The automatically generated total number of subject status accruals in Siebel Clinical Trial Management System.

    Actual Number

    No

    The total number of subject status accruals that the CRA manually records during the site visit.

    Comments

    No

    Text field to describe any discrepancy between Accruals Total and Actual Total.

    Reviewer Comments

    No

    Text field for reviewer comments about the trip report. Only the assigned reviewer can modify this field.

    Status Code

    Yes

    The subject status. The following subject visit statuses are preconfigured:

    • Screened
    • Screen Failure
    • Randomized
    • Enrolled
    • Completed
    • Early Terminated
    • Re-screened
    • Withdrawn

    Time Stamp

    Yes

    The date and time when the snapshot was generated.

    Visit Type

    Yes

    The type of clinical visit. The following clinical visit types are preconfigured:

    • Screening
    • Rescreening
    • Enrollment
    • End of Study
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