B Patient Auto-Selection in Partial Source Data Verification

This appendix describes the process by which patients are automatically selected for Partial Source Data Verification (PSDV).

You can set RDC to automatically select patients for 100% SDV based on an initial count, auto-select rate, or both. This quota of patient data to be verified can be specified in your study site patient SDV plan.

In order for auto-selection to work, the following conditions must be met:

• A study site patient SDV plan must be published in which an initial patient count, an auto-select rate, or both are specified. For more information, see Using Source Data Verification.
• The Pending Patient Updates job must be scheduled, at an interval of your choosing, to check for newly eligible patients and to process those patients marked for auto-selection. For more information, see Schedule Pending Patient Updates in the Oracle Clinical Administrator's Guide.

For more information, also see Setting Up Partial Source Data Verification in Oracle Clinical Creating a Study.

In this section:

• SDV Patient Pools
  
• Auto-select Processing
  
• Patient Eligibility is Reversed
  
• All Data for a Patient is Deleted
  
• Patient SDV Plan is Updated
  
• Patient Transferred from One Site to Another
  
• Data Transferred from One Patient to Another
  
• Patient ID Is Updated in a CRF (Key Changes or Mass Key Changes)
  
• DCI or Other Date Is Updated in a CRF