Source Data Verification

Abbreviation: SDV

Definition

Source Data Verification (SDV) is the process of confirming that data captured in study systems accurately reflect original source records.

SDV is used to detect transcription errors, missing data, and inconsistencies that could affect participant safety or study endpoints. Many programs use risk-based approaches that focus SDV on critical data rather than verifying every field. SDV documentation supports monitoring oversight and helps demonstrate sponsor control of trial quality. Effective SDV contributes to cleaner databases, faster query resolution, and stronger inspection outcomes.

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