Configure Partial SV

Click Monitor.
Click Set SV Settings.
Select Partial Source Verification.
The Subject Selection tab appears and displays the system default SV settings that are defined in Central Designer. The settings are read-only.
- You can modify the SV settings on a site-by-site basis, overriding the default values; proceed to Step 4.
  You can manually add subjects to the SV pool; proceed to Step 5.
Modify the system default SV settings for a site.
1. In the upper-right of the dialog box, in the Site drop-down list, select a site.
2. Click the Subject Selection tab.
3. In the System default SV settings section, enter the following information:
4. Enter the following information:
  - Number of initial subjects—The number of subjects to source verify in order, based on the time when the subject is assigned the status Enrolled. For example, to indicate that you must source verify the first seven subjects enrolled in a study, specify SVFIRSTNSUBJECTS=7. The default value is defined in Central Designer. This can’t be less than zero (0). If the system does not contain a SVFIRSTNSUBJECTS setting, the default value will be one hundred (100).
    This is also a Site property. A user with the Change Site SV Settings right can change the value at Site level. When a new system level First N is applied through deployment, InForm compares the value of each site with the current system value. If the site value equals the system value, the new system value will be applied to the site. Otherwise, the site value will not be changed.
  - Subject selection rate after initial subjects—The auto select percentage of the subjects to be included in Partial SV. The default value is defined in Central Designer. The value must be in the range of 0 to 100. If the system does not contain a SVAUTOSELECTRATE setting, the default value will be fifty (50).
    The auto select percentage is also a Site property. A user with the Change Site SV Settings right can change the value at the Site level. When a new system level percentage is applied through deployment, InForm compares the value of each site with the current system value. If the site value equals the system value, the new system value will be applied to the site. Otherwise, the site value will not be changed.
    
    If you select a rate of 100%, all forms for all subjects at the site with at least one item marked as SV Required must be verified.
Optionally, add specific subjects whose data you want to be source verified by manually adding the subjects to the SV pool.
These subjects are not considered in the SV Target Rate calculation.
1. Click the Subject Selection tab.
2. In the Select the subjects that will be verified at 100% section, enter the following information:
3. Enter or select a subject ID or subject number, and click Add.
  or
  
  On the right, click Import Subject List, submit the file with the list of subjects, and click OK.
Note: If your imported subject list contains data for subjects who are not present at the site, marked as excluded, or already present in the Manual Pool, those subjects are not imported. You are notified about who is and is not eligible after import.
Optionally, deselect subjects whose data you don't want to be source verified.
When you deselect a subject, the subject is returned to the SV Pool, and could be selected for source verification in the future by the automatic subject selection settings (Number of initial subjects and Subject selection rate after initial subjects).
1. Click the Subject Selection tab.
2. In the Enter subject number drop-down list, enter the subject's Subject ID or subject number, and click Add.
3. Select the subject number in the Subjects selected for verification list box, and click the Remove icon () two times.
Optionally, exclude subjects from source verification settings.
Excluded subjects are removed from the SV Eligible Pool, which means they aren't considered in the automatic subject selection settings, and are not SV required unless you manually select them for source verification. You can, however, mark an item associated with an excluded subject as critical.
1. Click the Subject Selection tab.
2. In the Enter subject number drop-down list, enter the subject's Subject ID or subject number, and click Add.
3. Select the subject number in the Subjects selected for verification list box, and click the Remove icon () one time.
Mark forms as critical for all subjects (add them to the critical forms list).
1. Click the Critical Data tab.
2. In the Form drop-down list, select a form with that you want verified for all subjects at the site.
3. In the Form override drop-down list, select Critical, and click OK.
Override form criticality settings.
1. Click the Critical Data tab.
2. In the Form drop-down list, select a form with that you want verified for all subjects at the site.
3. In the Form override drop-down list, select one of the following, and click OK.
  - Study Default—The criticality set for the form during the study design.
  - Critical—Sets the selected form to critical.
  - Not Critical—Sets the selected form to not critical.
Optionally, override item criticality settings.
1. Click the Critical Data tab.
2. In the Forms drop-down list, select a form with the item that you want to mark as critical.
3. In the table, select the item, and click Edit Selected Item.
4. Select the forms you want to set the item criticality for.
5. Select the criticality setting for the item:
  - 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).
  - Study Default—The criticality set for the item during the study design.
6. To make the item critical for subjects who are excluded from the SV Pool, in the Eligible subjects section, select the subjects and click Add.
  Note: If you set the item criticality to Study Default, study default is applied to all subjects. You cannot specify a subset of subjects in the Eligible subjects section.
7. Provide a reason for the change, and click OK.