Source Data Review (SDR), also called Source Document Review, is the process of comparing reported trial data to source records to confirm accuracy, completeness, and consistency.
SDR is a core monitoring activity used to detect transcription errors, missing documentation, protocol deviations, and potential data integrity risks. Monitoring plans define the scope and sampling approach for SDR, often emphasizing critical data and endpoints. SDR findings may lead to data queries, retraining, or CAPA when systemic issues are identified. Effective SDR strengthens confidence in trial results and supports inspection readiness by demonstrating verification of key data.