Setting Up Partial Source Data Verification for Clinical Protocols

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

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

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

To set up partial source data verification for a clinical protocol 

1. Navigate to the Administration - Clinical screen, then the Protocol List view.

2. In the Protocol list, create a new record and complete the necessary fields.

   For more information, see "Setting Up Clinical Protocols".

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

3. In the Protocol list, drill down on the protocol number field of the protocol 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	Type 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, type the percentage with CRFs that are part of SDV (source data verification).