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Setting Up Partial Source Data Verification for Clinical Regions

This topic describes how to set up PSDV (partial source data verification) for clinical regions. You set up this verification by entering PSDV values in some fields when you create a record for a clinical region. These values are automatically populated in the same fields for all of the sites that you associate with the clinical region. However, you can change these automatically populated values.

If you update the PSDV values in the fields of a clinical region, then the updated values are not automatically populated in the same fields of the sites that are already associated with the clinical region. If you associate new sites with the clinical region, then the updated values are automatically populated in the same fields of the new sites.

If you update the value (from Complete to Partial) in the SDV Policy field for a site that is associated with the clinical region, then the PSDV values in the fields of the clinical region are automatically populated in the same fields of the site.

To set up partial source data verification for a clinical region

1. Navigate to the Administration - Clinical screen, then the Region List view.
2. In the Region list, create a new record and complete the necessary fields.

   For more information, see Setting Up Clinical Regions.

   Alternatively, you can select an existing region record to update it.

3. In the Region list, drill down on the Region field of the region record.
4. Navigate to the More Info view.
5. Scroll down to the Partial Source Data Verification section, and complete the PSDV fields.

   The PSDV fields are described in the following table.

   Field	Comments
   Number of Initial Subjects	The number of initial subjects with CRFs (case report forms) to completely verify.
   Subject Auto-Select Rate	For the total number of subjects less the number of initial subjects, the percentage with CRFs that are part of SDV (source data verification).