SDV result

Source Data Verification (SDV) involves the review and comparison of data recorded in the source documents such as laboratory results, medical history, adverse event records, and so on against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors.

Once you have selected the SDV type for your study and configured either global, general, or target SDV settings, the planning stage may be considered complete. You can now start to verify the CRF data against the source documentation and then track the outcomes under the SDV Result tab.

Figure 1. SDV Result tab

The functionality and report tabs available under SDV Result differ depending on the SDV setting type selected for your study. You can learn more about these available features in the following table.

SDV setting type	Report tabs	Details
General SDV, Global SDV	Form	View SDV result records per CRF. Add new SDV result records to include some CRFs or unique forms that need to undergo SDV but are not on the list. Delete form-level SDV result records that are no longer relevant and move them to Form Level Removed tab. Export the SDV result record list to your computer as an XLSX file with both form and item data included. Access the SDV & SDR workload report by selecting Go to Chart from the workspace toolbar.
	Item	View SDV result records individually per CRF item (field). Export the SDV result record list to your computer as an XLSX file with both form and item data included.
	Form Level Removed	Permanently delete form-level SDV result records from the system.
Target SDV	Form	View TSDV result records per CRF. Export the SDV result record list to your computer as an XLSX file with both form and item data included, as well as subject tier assignment and history details. Access the SDV & SDR workload report by selecting Go to Chart from the workspace toolbar.
	Item	View TSDV result records individually per CRF item (field). Export the SDV result record list to your computer as an XLSX file with both form and item data included, as well as subject tier assignment and history details.
	Subject Tier Assignment	View subject tier assignment result. Add a subject tier assignment manually to include a subject in the SDV procedure. Override subject tire assignment manually. Delete a subject from the tier assignment to exclude them from the SDV procedure. Export the SDV result record list to your computer as an XLSX file with both form and item data included, as well as subject tier assignment and history details.
	Subject Tier History	View subject tier assignment history records. Export the SDV result record list to your computer as an XLSX file with both form and item data included, as well as subject tier assignment and history details.

SDV result

Search results