13 Using Source Data Verification
In order to implement partial source data verification (PSDV) for a study site, the site must have a published SDV Plan. Default SDV plan selections for the study are made in Oracle Clinical in the DCI Form Local Study Settings form and in the Maintain Study DCIs form. You can then simultaneously create and publish SDV plans for each site in the study based on those default values, or you can create and publish an SDV plan for each site individually, using the Source Data Verification Plan page in RDC. In either case, you can use this page to make updates to the Study Site SDV Plan through the course of the study. For more information see Setting Up Partial Source Data Verification in Oracle Clinical Creating a Study.
In Oracle Clinical Remote Data Capture, you can access the Source Data Verification (SDV) Plan page if you have either the BROWSE_SDVPLAN or UPDATE_SDVPLAN privilege. For an overview, see Source Data Verification Plan Page.
Note:
The Source Data Verification Plan tab is not available in RDC Test Mode.An SDV Plan can have two parts: a patient plan and a critical forms plan. The patient plan identifies a subset of patients that require 100% SDV, and the forms plan identifies forms that should be verified across all patients. For each type of plan, it is possible to have a published version, a draft version, and one or more obsolete versions.
For more information, see: