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. In the Forms drop-down list, select a form 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.

12. In the Form override drop-down list, select an override for the SV Critical setting for the selected form, as needed.
    • Study Default—The criticality set for the form during the study design. The CRF has been marked SV Critical message appears in the item section area of the dialog box, and no items are available for selection.
    • 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, and no items are available for selection.
    • 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.

13. For the selected form, select the item or itemset for which you want to set an override, and click Edit Selected Item.

    The Set SV settings—Override settings dialog box appears.

14. Set an override for all or some forms, as needed.
    1. In the Select which form(s) to apply override section, select one of the following options.
       • All Forms—Select to apply the override to all forms containing the item.
       • Individual forms—Select to apply the override to the item on selected form(s).

         The forms available in the list are forms containing the item. If a form is considered critical, it does not appear in the list.

    2. In the Override field, select one of the following options:
       • Not Critical—Sets the item or itemset to not critical for the selected form(s).
       • Critical—Sets the item or itemset to critical for the selected form(s).

         If All Forms is selected, all instances of the item must be verified. For more information, see About the Critical All Forms Effective SV state.

       • Study Default—The criticality set for the item during the study design.

         When you select this option, no override is applied, and the item uses the original study default setting. Any subjects in the Selected subjects list are removed and the study default is applied to all subjects.

15. Associate all subjects or some subjects with an item.
    1. In the Eligible subjects section, select one of the following options.
       • All Subjects—Select to associate all subjects with the item.
       • Individual subjects—Select to associate a subset of subjects with the item.

         The subjects available in the list are those that are excluded from the SV Pool. Subjects who are excluded will not have items to be verified unless the form has been marked critical.

         Subjects that are part of the SV Pool are not available to be selected for critical items because they must have all SV required items on all forms verified. Critical forms take precedence over the subject pool.

    2. If you selected individual subjects, click Add to transfer the subject(s) to the Selected subjects list.
    3. Click Remove to remove subjects from the Selected subjects list.
16. Click OK.

    The Reason for Change dialog box appears.

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