Source data verification (SDV)
In Oversight, quality & inspection
Source data verification is comparing what is reported in the case report form against the original source documents to confirm it matches. It used to be done on 100% of data; risk-based approaches now target it at the fields that matter most. It answers one narrow question — does the reported value match the source — and nothing more.
Why it matters
SDV used to consume most of a monitor's time. Risk-based approaches have shifted that effort towards reviewing whether the trial is being run properly at all, which is where the real risks turn out to be.
Example
The monitor opens the participant's clinic notes and confirms that the systolic blood pressure of 148 recorded in the eCRF matches what was written on the day.
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