Configuring Partial SV

1. To configure Partial SV from the Source Verification Listing page:
   1. In the navigation toolbar, click Monitor.

      The Source Verification Listing page appears.

   2. Click Set SV Settings.

      The Set SV settings dialog box appears. For a description of the fields on this page, see Set SV settings dialog box.

   3. Proceed to step 3.
2. To configure Partial SV from the Data Viewer:
   1. In the navigation toolbar, click Review.

      The Summary View appears.

   2. In the Data Viewer toolbar, select Options > Set SV settings.

      The Set SV settings dialog box appears. For a description of the fields on this page, see Set SV settings dialog box.

3. In the Site drop-down list, select the site for which you want to configure Partial SV.
   • To view the audit history for the site, click the Audit History icon ( ) next to the Site drop-down list. For more information, see Set SV settings—Audit History dialog box.
4. Indicate whether you want to disable or enable partial source verification for the selected site.
   • To disable Partial SV, select Source Verify all Data.

     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.

     The Subject selection rate after initial subjects field is automatically set to 100%, and is then disabled.

   • To use Partial SV, select Partial Source Verification.

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

5. Click the Subject Selection tab.
6. In the Number of initial subjects field, enter the number of initial subjects enrolled in the site that you want to be source verified. The default is 0.
7. In the Subject selection rate after initial subjects field, enter the SV Target Rate.

   This is 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.

   Note: The default rate of 100% refers to all forms associated with any subject in the site that has at least one item marked as SV Required.

8. Optionally, in the Enter subject number drop-down list, type the Subject ID or select a subject number that you want to add to the Subjects selected for verification list, and click Add.

   The subject number appears in the adjacent box.

   1. To display all the available, enrolled subjects for the site, clear the Enter subject number drop-down list.
   2. To exclude a subject, select its number in the Subjects selected for verification list box, and click the Remove icon ( ) one time.

      A grey Exclude icon ( ) appears next to the subject number in the list box. All excluded subjects appear in the list with the Exclude icon and the Removed label.

      The excluded subject is removed from the SV Eligible Pool.

   3. To remove a subject from the list, select its number in the Subjects selected for verification list box, and click the Remove icon ( ) two times.

      The removed subject is returned to the SV Eligible Pool.

   Note: Manually-selected subjects are not considered in the SV Target Rate calculation.

9. Optionally, to import subjects, click the Import Subject List link.

   The Import Subject List dialog box appears. For a description of the fields on this page, see Set SV settings—Import subjects dialog box.

   1. Click Browse, navigate to the file, and click Submit.

      When you import a subject list, the InForm application filters out subjects not present in the site, excluded subjects, and subjects already present in the Manual Pool.

      The result is a list of qualified subject IDs to be added to the Manual Pool. For subjects that cannot be added to the Manual Pool, a notification dialog box appears. The dialog box displays a scrollable list of subjects successfully added, along with a list of subjects not meeting the acceptance criteria.

   2. Click OK to close the Set SV settings—Import subjects dialog box.
10. Click the Critical Data tab.
11. Select the forms that you want to include in the Critical Forms list.

    These are the forms that you want verified for all subjects in the site. You can change the form selection at any time during the study.

    The InForm application does not prevent you from verifying forms that are not currently selected for source verification. That is, you can enter Verify mode, verify the appropriate items on a form, and submit the changes even if the form was not set as SV Required during study design. This allows you to verify a greater number of forms than what was selected by the SV Target Rate.

    1. In the Critical column, select the checkbox next to every form that you want to select as critical.
       • For a form designated as critical (the Critical checkbox is selected), the critical item selection is disabled, and 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.
    2. To remove a form from the Critical Forms list, deselect the checkbox in the Critical column next to the form.
12. Override the SV Critical setting for an item or itemset, as needed.
    1. In the Forms column, highlight a form.

       The names of all the form items and itemsets appear in the right-hand pane, with the following information:

       • 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.

       • Item—The item or itemset on the selected form.

         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.

       • Effective SV State—A status that indicates the criticality of an item based on the study and override settings. The options are Not SV Critical and SV Critical. For more information, see Critical items—Effective SV states.
       • Override—A status that indicates the SV Critical override setting for the item or itemset.
13. In the Override column, for each item, select one of the following options.
    • Study Default—The criticality set for the item during the study design.
    • This Form—Sets the item to critical for only the selected form.
    • All Forms—Sets the item to critical for all forms. All instances of the item must be verified, not just the items on the form on which you set the override. For more information, see About the Critical All Forms Effective SV state.
    • Not Critical—Sets the item to not critical for only the selected form.
14. Click OK to save any changes you made to the Partial SV settings.

    The Reason for Change dialog box appears.

15. Enter a brief description of the configuration changes you made, and click OK.