Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits > Process of Defining Subject Visit Templates >

Defining Subject Visits

This topic describes how to define subject visits in a subject visit template.

This task is a step in Process of Defining Subject Visit Templates.

To define subject visits

1. Navigate to the Administration - Clinical screen, then the Visit Templates view.
2. For the new template version record, create a visit record in the Visits list for each visit that a subject is to make to the site.

   Some fields are described in the following table.

   Field	Comments
   # CRF Pages	Number of CRF (case report form) pages.
   Lead	The lead time from the start date. The start date is defined in the Schedule Date field when scheduling the subject.
   Lead Units	Units for lead time.
   Max	The time after the lead time that the visit can take place. For example, if Max is 2 and Min/Max Units is days, then the visit can take place up to two days after the scheduled visit. Do not leave this field blank.
   Min	The time before the lead time that the visit can take place. For example, if Min is 1 and Min/Max Units is days, then the visit can take place one day before the scheduled date. Do not leave this field empty.
   Min/Max Units	Units for the Min and Max values. Do not leave this field empty.
   Name	Name of the visit; for example, screening or baseline.
   Planned	Select this field to define a subject visit as a planned visit. This field is selected by default.
   Sequence	Sequence number of the visits. Typically, the first visit that is made has order number 1.
   Status	The following subject status values are provided: Screened Screen Failure Randomized Enrolled Completed Early Terminated Re-screened Withdrawn The Status field is not copied when the subject visit template is copied to the subject's visit plan.
   Status Tracking Visit	Select this field to enable automatic tracking of the status in the Subject Status MVG (multi value group) for each visit type. Only one visit can be set as the status tracking visit for each visit type. For example, if a Treatment visit type has TreatmentPhase1, TreatmentPhase2, and TreatmentPhase3 clinical visits defined, then only TreatmentPhase3 can be set as the status tracking visit. When the Status Tracking Visit field is selected for a visit, the following status records are automatically created in the Subject Status MVG when each predefined visit type is processed: A Visit Type value of Screening creates a Screened status record in the Subject Status MVG. A Visit Type value of Re-Screening creates a Re-screened status record in the Subject Status MVG. A Visit Type value of Enrollment creates an Enrolled status record in the Subject Status MVG. A Visit Type value of End of Study creates a Completed status record in the Subject Status MVG. You can manually override the automatic value in the Subject Status MVG. Any create, update, or delete operations on the tracked status fields trigger automatic create, update, and delete operations in the Subject Status MVG. Automatic status tracking is not enabled for custom values in the Visit Type list. The Status Tracking Visit field can be edited only in the subject visit template. This field is read-only when copied to the subject's visit plan. If you do not enable automatic status tracking for a clinical visit, then you can manually create, update, and delete status records in the Subject Status MVG. The following conditions apply: Only one status record can be created for each visit type. Multiple status records for the same visit type are not permitted. If Visit Type is not null, then it must be unique. When Visit Type is null, the status value must be unique. Multiple status records with the same Status value, and a null Visit Type, are not permitted. The value pair of Visit Type and Status must be unique.
   Visit Type	This field indicates the type of clinical visit. The following preconfigured values are available: Screening Rescreening Enrollment End of Study Visit Type values can be added, modified, or deleted.