Setting Up Partial Source Data Verification for Sites

This topic describes how to set up PSDV (partial source data verification) for sites. You set up this verification by entering PSDV values in some fields when you create or update a record for a site.

To set up partial source data verification for a site 

1. Navigate to the Site Management screen, then the Protocol Site List view.

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

   For more information, see "Creating Sites for Clinical Trials".

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

3. In the Protocol Site list, drill down on the site number field of the site record.

4. Navigate to the More Info view.

5. Scroll down to the Integration section and the Partial Source Data Verification section and complete the PSDV fields.

   The PSDV fields are described in the following table.

   Field	Comments
   Use CDMS Auto-Select Rule	If you use an integrated CDMS (clinical data management system), such as Oracle Health Sciences InForm, then select this field to indicate that the PSDV fields in the site record are not used in PSDV. In this scenario, the SDV Required field for the appropriate subject records is populated from the CDMS. Clear this field to indicate that the PSDV fields in the site record are used in PSDV. When you save the record after you select this field, the SDV Policy field is automatically populated with a value of External. This field is disabled until you complete the following tasks in the designated order: Integrate Oracle Health Sciences InForm studies with Siebel clinical. For more information, see "Overview of Clinical Data Management System Integration". Select a value in the Primary Site Address field in the Integration section. You set up selectable addresses in the Addresses view of the Site Management screen. Select the Activate for Synchronization field in the Integration section.
   SDV Policy	Select the policy for SDV (source data verification). Valid values include Complete, Partial, and External. The default value is Complete. When the value is Complete, all of the subjects associated with the site record are part of complete SDV, and the SDV Required field in those subject records is set to Yes.
   Number of Initial Subjects	Type the number of initial subjects with CRFs (case report forms) to completely verify. You can change this field only if the SDV Policy field has a value of Partial. If the protocol or region record that is associated with this site already has a value in this same field, then that value is automatically populated in this field. However, you can change this automatically populated value.
   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. You can change this field only if the SDV Policy field has a value of Partial. If the protocol or region record that is associated with this site already has a value in this same field, then that value is automatically populated in this field. However, you can change this automatically populated value.
   Total Subjects Requiring SDV	Displays the number of subjects who are included in SDV. This field is read-only. The calculation of this field value follows: (Number of Initial Subjects) plus [(Total Subjects in the Site Pool) less (Number of Initial Subjects) times Subject Auto-Select Rate] For more information about this field, see "Recalculating Clinical Subjects Requiring Source Data Verification".
   Total Subjects in Site Pool	Displays the number of subjects in the site pool. This field is read-only.