Setting Up Partial Source Data Verification for Clinical Subjects

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

To set up partial source data verification for a clinical subject

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.

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

4. Navigate to the Subjects view.

5. In the Subjects list, create a new record and complete the necessary fields as shown in the following table.

   For more information, see Creating Records for Clinical Subjects.

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

   Field	Comments
   SDV Required	Displays an indication of whether SDV (source data verification) is necessary for the CRFs (case report forms) of the subject. The value in this field can change in the following ways: Manual. You can manually change the field value. To change the field value, drill down on the screening number field of the subject record to navigate to the subject form. Site. The field value can be automatically populated using the PSDV field values of the site record that is associated with the subject record. If the value in the SDV Policy field for the associated site record is Complete, then the SDV Required field for the subject record is Yes. If the value in the SDV Policy field for the associated site record is Partial, then the SDV Required field for the subject record can be Yes or No. The value depends on the other PSDV field values. Status. This field can be automatically populated when a status rule set exists for the Status field of the subject record. If such a rule set exists, then this field is automatically populated with a value of Yes or No. To set up this status rule set in Siebel Tools, enter values in the SDV Subject Status user properties of the Clinical Subject business component. For example, enter the following value in the SDV Subject Status 1 user property: "Early Terminated","Adverse Effect","Y". Then enter the following value in the SDV Subject Status 2 user property: "Screen Failure","", "Y". In this example, if a subject terminates a study early because of an adverse effect, or if a subject fails screening, then the SDV Required field is automatically populated with a value of Yes. Set the CL Highest Preference SDV Rule system preference to determine the priority order in which to implement these 3 methods (Manual, Site, and Status) to change the SDV Required field of a subject record. For more information, see System Preferences in Siebel Clinical.
   SDV Last Updated Source	Displays the reason for the value in the SDV Required field. This field is read-only. It can have the following values: Site. The value in the SDV Required field is the result of the PSDV fields of the site record that is associated with the subject record. The subject records with this value are included in the site pool. Subject Status. The value in the SDV Required field is the result of a status rule set for the Status field of the subject record. The subject records with this value are included in the status pool. Manual. The user selected the value in the SDV Required field for the subject record. The subject records with this value are included in the subject pool. External. The value in the SDV Required field is the result of incoming data from an integrated CDMS (clinical data management system).