Process of Defining Subject Visit Templates

To define a subject visit template for scheduling subject visits, perform the following tasks:

"Creating Subject Visit Templates"
"Defining Versions for Subject Visit Templates"
"Defining Subject Visits"
"Defining Planned Subject Visits"
"Defining Activities for Subject Visits"

Creating Subject Visit Templates

This topic describes how to create a subject visit template.

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

To create a subject visit template

Navigate to the Administration - Clinical screen, then the Visit Templates view.

In the Subject Visit Templates list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Name	Type the name of the subject visit template.
Protocol #	Select the protocol for the subject visit template. Select from the list of existing protocols in the Pick Protocol dialog box.
Title	Displays the title for the protocol that you select.
Comments	Type comments about the subject visit template.

Defining Versions for Subject Visit Templates

This topic describes how to define a version for a subject visit template.

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

To define a version for a subject visit template

Navigate to the Administration - Clinical screen, then the Visit Templates view.

In the Template Versions list, create a new template version record or select a version that you created by using the Versions view.

Some fields are described in the following table.

Field	Comments
Version	Select the version of the subject visit template.
Comments	Type comments about the version. This field has a maximum character length of 250 characters. This field is not copied when you copy the subject visit template.
Start Date	Select the date that you create the version of the subject visit template.
End Date	Select the date that you must complete the version of the subject visit template.
Status	Select the status of the version of the subject visit template. The following values are available: In Progress Approved Obsolete When you create a new version of the subject visit template, the Status field is populated with a value of In Progress.
Change Summary	Type a summary of changes to the version of the subject visit template.

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

Navigate to the Administration - Clinical screen, then the Visit Templates view.

For the new template version record, create a visit record in the Visits list for each visit that a subject will make to the site.

Some fields are described in the following table.

Field	Comments
Sequence	Type the sequence number of the visit. Typically, the first visit has a sequence number of 1.
Visit Type	Select the type of clinical visit. The following preconfigured values are available: Screening Rescreening Enrollment End of Study You can add, modify, or delete values for the Visit Type field.
Name	Type the 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.
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. You can set only one visit as the status tracking visit for each visit type. For example, if TreatmentPhase1, TreatmentPhase2, and TreatmentPhase3 clinical visits exist for a Treatment visit type, then you can set only TreatmentPhase3 as the status tracking visit. When you select the Status Tracking Visit field 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. You can edit the Status Tracking Visit field 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: You can create only one status record 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.
Lead	Type the lead time from the start date. You define the start date in the Schedule Date field when scheduling the subject.
Lead Units	Select the units for the lead time.
Min	Type the time before the lead time that the visit can occur. For example, if Min is 1 and Min/Max Units is days, then the visit can occur one day before the scheduled date. Do not leave this field empty.
Max	Type the time after the lead time that the visit can occur. For example, if Max is 2 and Min/Max Units is days, then the visit can occur up to two days after the scheduled visit. Do not leave this field empty.
Min/Max Units	Select the units for the Min and Max values. Do not leave this field empty.
# CRF Pages	Type the number of CRF (case report form) pages.
Status	Select the status of the visit. The following subject status values are available: Screened Screen Failure Randomized Enrolled Completed Early Terminated Re-screened Withdrawn The Status field is not copied when you copy the subject visit template to the subject's visit plan.

Defining Planned Subject Visits

This task describes how to define planned subject visits for the clinical trial. For example, complete this task to define whether treatment visits or surgery visits are planned for a subject.

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

To define planned subject visits

Navigate to the Administration - Clinical screen, then the Visit Templates view.
In the Visits list, define the planned subject visits using one of the following methods:
1. To define all the subject visits as planned visits, click Plan All.
2. To define selected subject visits as planned visits, select the Planned field for each visit.

Defining Activities for Subject Visits

This task describes how to define activities for subject visits in the clinical trial.

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

To define activities for a subject visit

Navigate to the Administration - Clinical screen, then the Visit Templates view.

For each visit record, create a set of activity records in the Activities list to describe the procedures and tasks required for the visit.

Some fields are described in the following table.

Field	Comments
Duration	Select the estimated length of time to complete the activity.
Payment Flag	Select this field to indicate that you pay the investigator for this activity. This flag is selected by default. For more information about payments, see Chapter 8, "Setting Up and Making Clinical Payments."
Payment Amount	Type the standard amount that you pay the investigator for this activity. You can adjust this amount for each site or each individual.