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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.
  4. Indicate whether you want to disable or enable partial source verification for the selected site.
  5. 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.
  6. 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.

  7. 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 (Partial SV icon. Click one time to exclude the selected subject.) one time.

      A grey Exclude icon (Partial SV icon. Indicates subject is excluded.) 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 (Partial SV icon. Click two times to remove the selected subject.) 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.

  8. 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.
  9. 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 Source verify the following forms for all subjects field, select a form name, and then click Submit.

      The form name appears in the adjacent box.

    2. Repeat step 9a as needed until all the forms are added to the Critical Forms list.
    3. To remove a form from the Critical Forms list, select the form name in the Critical Forms list box, and click the Remove icon (Partial SV icon. Click one time to remove the selected form.) one time.
  10. Click OK to save any changes you made to the Partial SV settings.

    The Reason for Change dialog box appears.

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