Checklist—Criteria for configuring Partial SV

q

1

Select a site.

The site for which you want to configure Partial SV.

Set SV settings dialog box.

q

2

Specify whether to use Partial SV.

• Source Verify all Data (default)—Select to disable partial source verification for the selected site.

  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.

Partial source verification (Partial SV).

q

3

Set up the Subject list.

Identify the subjects to source verify.

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

Subjects and the SV Pool.

• Set the 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.

Automatically selected subjects.

• Enter or import subjects—You can manually select the subjects for a site that you want to be source verified, or you can have the InForm application automatically select them based on the SV Target Rate that you define.

  Alternatively, you can import a text file that specifies a set of subjects that you want to source verify.

Manually selected subjects.

Imported subjects.

• Decide whether to exclude subjects—You can exclude a subject from the SV Pool.

Excluded subjects.

q

4

Set Critical Forms List

Identifies the forms to source verify for all subjects.

You manually select the forms that you want to always be source verified.

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.

Critical Forms.

q

5

Set the criticality overrides for a form, as needed.

You can manually override the criticality setting for a form or forms.

Form criticality overrides.

q

6

Set the criticality overrides for items, as needed.

You can manually override the criticality setting for the items or itemsets.

Critical items.

Item or itemset criticality overrides.

q

7

Associate all or some subjects with critical items, as needed.

You can manually associate some or all subjects with critical items.

Criticality and override settings.