Setting Up Partial Source Data Verification

Oracle Clinical and RDC Onsite now support creating a risk-based source data verification (SDV) plan that identifies only a subset of data requiring verification in RDC.

An SDV plan can have one or both of the following components:

• A Critical Forms Plan identifies CRFs that need to be verified against the original data for all patients.

• A Patients Plan identifies patients in the study that must have 100% of their data verified. The percentage of patients requiring 100% verification can be different for different study sites. Patients can be individually selected for SDV or automatically selected based on either or both of these options:

  • A count of initial patients to be 100% source data verified.

  • A default rate of automatic selection of patients for source data verification.

You set system-wide default SDV plan values in Oracle Clinical and publish default plans based on those values for all study sites. You can then make changes to the plan for any study site in RDC Onsite.

When a patient SDV plan is published, automated patient selection begins. With the appropriate privileges you can see in the RDC Onsite user interface which patients and CRFs have been selected for SDV.

You can introduce partial source data verification in an ongoing study.

For more information, see the following:

• Marking Patients Eligible for Source Data Verification.

• Marking a DCI as Critical for Source Data Verification.

• Source Data Verification Plan Defaults.

• Publish Source Data Verification Plans for All Sites in Oracle Clinical Conducting a Study. After you have selected default values, use this batch job to publish a plan for every study site. You can then modify it for different sites in RDC.

• Schedule a Job to Manage Pending Patient Updates in Oracle Clinical Administrator's Guide. Set up this batch job to run at regular intervals to update patients requiring source data verification.

• Execute Pending Patient Updates in Oracle Clinical Conducting a Study. The same update job can be run at any time. It resolves locking conflicts that may prevent work in some areas of Oracle Clinical.

• Privileges for Partial Source Data Verification in Oracle Clinical Remote Data Capture Onsite Administrator's Guide.

• Source Data Verification Plan Page in Oracle Clinical Remote Data Capture Onsite User's Guide.

• Creating and Modifying a Study Site SDV Plan in Oracle Clinical Remote Data Capture Onsite User's Guide.

• Verifying CRFs in Oracle Clinical Remote Data Capture Onsite User's Guide.

• Patient Auto-Selection in Partial Source Data Verification in Oracle Clinical Remote Data Capture User's Guide

• Web Services for Runtime Modification of SDV Plans in Oracle Clinical Application Programming Interface Guide