Siebel CRM Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2016 E52416-01 |
|
Previous |
Next |
View PDF |
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
Navigate to the Site Management screen, then the Protocol Site List view.
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.
In the Protocol Site list, drill down on the site number field of the site record.
Navigate to the Subjects view.
In the Subjects list, create a new record and complete the necessary fields.
For more information, see "Creating Records for Clinical Subjects"
Alternatively, you can select an existing subject record to update it.
The PSDV fields are described in the following table.
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:
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). |