Bookshelf v7.5: Defining a Subject Visit Template

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Defining a Subject Visit Template

Subject visit templates allow you to set up a template schedule based on the protocol. The template is then used to generate screening, rescreening, and enrollment schedules for each subject, according to the subject's screening, rescreening, and enrollment dates.

About Subject Visit Templates

Figure 10 and Figure 11 illustrate the relationship between the subject visit template and the visit schedule created for a given subject.

For example, if the subject visit template shown in Figure 10 is applied to a subject with a screen date of 11/20/2001, a rescreen date of 11/22/2001, and an enrollment date of 11/26/2001, the resulting visit schedule is as shown in Figure 11.

Figure 10. Visits List

Figure 11. Subject Form and Visits List in the Visit Plans View

The first screening visit takes place on the screen date because the lead time for this visit is 0. But this visit can be rescheduled to 11/21/2002 because the allowed variation for this visit is two days after the lead date (Max = 2 days). If you enter a date before the 11/20/2002 or after the 11/21/2002, an alert message appears, warning you that the entered date is outside the allowed range.

Similarly, the first enrollment visit takes place on 12/03/2001 because the lead time for this visit is 1 week after the enrollment date of 11/26/2001.

If the protocol is amended, you will need to create new versions of the subject visit template to reflect the modifications made to the protocol. See Revising Protocols.

Creating a Subject Visit Template

The following procedure describes how to add a subject visit template.

To add a subject visit template

From the application-level menu, choose View > Site Map > Clinical Administration > Visit Templates.

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

Some of the fields in the Subject Visit Template record are described in the following table.


Field	Comments
Name	Name of the new subject visit template.
Protocol #	Protocol to which this subject visit template is to be associated. Select from list of existing protocols in the Pick Protocol dialog box.
Protocol Title	Tied to the Protocol # field.

For the new subject visit template, in the Template Versions list, create a new template version record.

For the new template version record, in the Visits list, create a visit record for each visit (screening, rescreening, and enrollment) that a subject is to make to the site.

Some of the fields in a Visits record are described in the following table.


Field	Comments
Lead	For Screening visits, this is the time from the screen date. For example, in Figure 10 the Lead value for the screening visit is 0. For Rescreening visits, this is the time from the rescreen date. For Enrollment visits, this is the time from the enrollment date. The Lead value for an enrollment visit taking place 1 week after enrollment would be 1, assuming the Lead Unit is weeks.
Lead Units	Units for lead time.
Max	The time after the lead time that the visit may take place. For example, if Max=2 and Min/Max Units = days, the visit may 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 may take place. For example, if Min=1 and Min/Max Units = days, the visit may 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.
Sequence	Sequence number of the visits. Typically, the first visit that will be made has order number 1.
Visit Type	Screening, Rescreening, or Enrollment. If Screening is selected, the visit due date will be based on the screen date. If Rescreen is selected, the visit due date will be based on the rescreen date. If Enrollment is selected, the visit date will be based on the enrollment date. The choices in this drop-down list are configured by using the CLNCL_SUBJ_VST_TMPL_TYPE type in the List of Values.

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

Some of the fields in the Activities record are described in the following table.


Field	Comments
Duration	Length of time the activity is estimated to take.
Payment Amount	The standard amount that the investigator is to be paid for this activity. This amount may be adjusted on a per site or per individual basis.
Payment Flag	Select this flag if the investigator is to be paid for this activity.

For more information about payments, see Setting Up and Making Subject Activity Payments.