Applying Revised Subject Visit Templates to Clinical Subjects
This topic describes how to apply a new version of the subject visit template to a subject when you revise a protocol mid-study. When you activate the new version of the subject visit template at the site, the Schedule button is enabled in the Subjects screen.
To apply a revised subject visit template to a clinical subject
Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to update subject visits.
Navigate to the Subjects view.
Complete one of the following steps:
To update the subject visit templates for all subjects at the site, click Apply Version to All.
For all subjects at this site, except for those subjects with a Status field value of Early Terminated or Completed, the value in the Informed Consent Dates field is cleared, and the record for the new, active version of the template is selected in the dialog box for the Informed Consent Dates field.
To update the subject visit templates for some subjects at the site, select the subject records, and click Apply Version to Selected.
For the selected subjects, except for those subjects with a Status field value of Early Terminated or Completed, the value in the Informed Consent Dates field is cleared, and the record for the new, active version of the template is selected in the dialog box for the Informed Consent Dates field.
In the Subjects list, drill down on the screening number field of the enrolled subject whose schedule you want to update for the revised subject visit template.
The Visits view of the Subjects screen appears.
In the Subjects form, complete the following steps to enter the informed consent date for the new version:
Click the select button in the Informed Consent field to open the Informed Consent Dates dialog box.
Enter an informed consent date for the new version, and click OK.
Click Schedule, and complete the following steps:
Enter the Schedule Date.
A message appears asking if you want to delete uncompleted visits from the old version of the subject visit template and completed visits from the new version of the subject visit template. Non-applicable visits are those visits generated from the old template version that are scheduled to occur after the new Informed Consent Date and those visits generated by the new template version that have due dates prior to the new Informed Consent Date.
Complete one of the following steps:
Click OK.
The non-applicable visits are deleted.
Click Cancel.
The new visits for the new protocol version are appended to the existing Visit Plans list. No visits are deleted. Typically, if you click Cancel, then you can return at a later stage to the Visits list and delete future-schedÂuled visits from the original version of the subject visit template and past-scheduled visits from the new version of the subject visit template.
The Subject Visits record updates as follows:All the visits in the new active subject visit template are copied to the Visit Plans list.
The Visit Type, Name, Start Date, Planned, Status Tracking Visit, and Status fields are copied from the subject visit template.
The planned dates and due dates are calculated using the lead time in the subject visit template and the start date in the Schedule Date field. The planned dates and due dates are calculated as follows:
planned or due date equals schedule date plus lead time.