Terminating Clinical Trials Early for Clinical Subjects

On occasion, you might have to terminate a subject's participation in a trial before completion of the trial. For example, the subject might no longer want to take part in the trial, or the subject might fail a screening.

To terminate a clinical trial early for a clinical subject  

1. Navigate to the Subjects screen, then the Subject List view.

2. In the Subject list, drill down on the screening number field of the subject of the 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   • To indicate that the subject withdrew from the trial, enter the reason in the Withdrawn Reason field.

   • To indicate that the subject's trial terminated early, select the reason in the Early Termination Reason field.

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   • To indicate that the subject withdrew from the trial, enter the date in the Withdrawn Date field.

   • To indicate that the subject's trial terminated early, enter the date in the Early Terminated Date field.

5. Save the record.

   Subject Termination Event	Automatic Field Updates
   Screen Failure	The Subject record automatically updates as follows: A record with a Status field value of Screen Failure is added to the Subject Status MVG (multi value group), and the value in the Screen Failure Date field is copied to the Date field of the Subject Status MVG. The Status field is updated to Screen Failure.
   Early Terminated	The Subject record automatically updates as follows: A record with a Status field value of Early Terminated is added to the Subject Status MVG, and the value in the Early Terminated Date field is copied to the Date field of the Subject Status MVG. The Status field is updated to Early Terminated.
   Withdrawn	The Subject record automatically updates as follows: A record with a Status field value of Withdrawn is added to the Subject Status MVG, and the value in the Withdrawn Date field is copied to the Date field of the Subject Status MVG. The Status field is updated to Withdrawn.

   
   

When a Screen Failure or Early Terminated event occurs, all remaining visits for the subject are deleted. For more information, see the LS Subject Terminate Study Status Value 1 user property in "User Properties for Business Components in Siebel Clinical".