Set SV settings dialog box

Site drop-down list

The site for which you want to configure Partial SV.

• The drop-down list displays the mnemonics and names of all sites to which you have access, in alphabetical order.
• If you access this dialog box from the Source Verification Listing page, the Site selected on that page appears in this field.

Audit Trail icon

Click to open the Set SV settings—Audit History dialog box, from which you can view the audit history for the selected site.

Source Verify all Data

Select to disable partial source verification for the selected site. Default.

When you select this option, you are setting the subject selection rate to 100%. All forms with at least one item set as SV Required must be verified. All other options in the Set SV settings dialog box are disabled.

Partial Source Verification

Select to enable partial source verification for the selected site.

When you select this option, you are choosing to use Partial SV. All options in the Set SV settings dialog box are enabled.

Subject Selection

Import Subject List link

Click to open the Set SV settings—Import subjects dialog box, from which you can enter a file name or browse to a text file of enrolled subject data.

• Click Browse to navigate to the file you want to import.
• Click Submit to start the import.

Number of initial subjects

The number of initial subjects enrolled in the site that you want to be source verified. The default is 0.

Subject selection rate after initial subjects

The SV Target Rate. The percentage at which you want subjects to be selected for source verification after the initial subjects are verified.

This is the percentage of subjects that the automated subject selection algorithm attempts to meet. The default is 100%, which means all subjects are selected.

Enter subject number drop-down list

The subjects available to add to the Subjects selected for verification list.

Add link

Click to add the entered or selected subject number to the adjacent Subjects selected for verification list box.

Subjects selected for source verification list box

The list of subjects selected for source verification, and the method of selection.

• Initial Subject—Subject was selected as an initial subject to source verify.
• Auto—Subject was added by the auto-select process.
• Manual—Subject was entered manually or selected from the Enter subject number drop-down list.
• Imported—Subject was imported.
• Removed—Subject was excluded.

Exclude icon

Click one time to exclude a subject from the SV Pool. The excluded subject is removed from the SV Eligible Pool.

Remove icon

Click two times to remove a subject from the Subject List. The removed subject is returned to the SV Eligible Pool.

Critical Data

Form drop-down list

The list of forms in your study that you can include in the Critical Forms list.

• For a form designated as critical, the CRF has been marked SV Critical message appears in the item section area of the dialog box.
• For a form designated as not critical, the items and itemsets on the form appear in the item section of the dialog box.
• Hover over the form name to display the FormRefName as a tooltip.

  The items and itemsets on the form appear in the grid.

• The list of items on the form includes all items from current and previous study versions. This allows items started on earlier study versions to be marked critical.
• Only items designated as SV Required are included in the selection list.
• Only itemset parent items appear, and not the child items of the itemset.

Form override drop-down list

The override setting for the selected form.

• Study Default—The criticality set for the form during the study design.
• Critical—Sets the selected form to critical. The CRF has been marked SV Critical message appears in the item section area of the dialog box.
• Not Critical—Sets the selected form to not critical.

  Note: You cannot set the override value to be the same as the study default value.

Edit Selected Item button

Opens the Set SV Settings—Override settings dialog box from which you can set overrides for the selected item or itemset.

Question

The question field on the selected form.

Study Critical items are marked with a superscript asterisk (*) at the beginning of the Item Question. For an itemset where the Item Question is blank (empty), the Item Question is replaced by the text: [ITEMSETREFNAME] is an ITEMSET.

Study Default State

The study default value for the item: Critical or Not Critical.

Form Selection

Indicates whether this item is set to be source verified on all forms or on a subset of forms.

Subject Selection

Indicates whether this item is set to be source verified for all subjects or for a subset of subjects.

Override Selection

The override setting for the item.

• Study Default—The criticality set for the item during the study design.
• Critical—Sets the item to critical for all forms or the selected form(s).
• Not Critical—Sets the item to not critical for all forms or the selected form(s).

Effective SV State

A status that indicates the criticality of an item based on the study and override settings. For more information, see Critical items—Effective SV states.

• Not Critical
• Critical

OK

Click to save changes. The Reason for Change dialog box appears.

Cancel

Click to close the dialog box without saving changes.