Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits >

Terminating a Clinical Subject's Trial Early


On occasion, it might be necessary to terminate a subject's participation in a trial before completion of the trial. For example, the subject no longer wants to take part in the trial or because the subject failed a screening.

To terminate a clinical subject's trial early

  1. Navigate to the Subjects screen, then the Subject List view.
  2. In the Subjects list, Drill down on the Screening number (#) of the subject whose trial you want to terminate.
  3. Enter the reason for terminating the subject's trial using one of the following methods:
    • To indicate that the subject failed the screening, enter the reason in the Screen Failure Reason field.
    • To indicate that the subject was withdrawn from the trial, enter the reason in the Withdrawn Reason field.
    • To indicate that the subject's trial was terminated early, select the reason in the Early Termination Reason list.
  4. Enter the date for terminating the subject's trial using one of the following methods:
    • To indicate that the subject failed the screening, enter the date in the Screen Failure Date field.
    • To indicate that the subject was withdrawn from the trial, enter the date in the Withdrawn Date field.
    • To indicate that the subject's trial was terminated early, enter the date in the Early Terminated Date field.
  5. Save the record.
    Subject Termination Event
    Automatic Status Updates

    Screen Failure

    The Subject record automatically updates as follows:

    • A Screen Failure status record is added to the Subject Status MVG, and the Screen Failure Date value is copied to the Subject Status MVG Date field.
    • The Status field is updated to Screen Failure.

    Early Terminated

    The Subject record automatically updates as follows:

    • An Early Terminated status record is added to the Subject Status MVG, and the Early Terminated Date value is copied to the Subject Status MVG Date field.
    • The Status field is updated to Early Terminated.

    Withdrawn

    The Subject record automatically updates as follows:

    • A Withdrawn status record is added to the Subject Status MVG, and the Withdrawn Date value is copied to the Subject Status MVG Date field.
    • The Status field is updated to Withdrawn.

When a Screen Failure or Early Terminated event occurs, all remaining visits for the subject are deleted.

Siebel Clinical Trial Management System Guide Copyright © 2013, Oracle and/or its affiliates. All rights reserved. Legal Notices.