Analysis Proves Positive for RBM

Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced positive results of a data-driven analysis conducted in collaboration with TransCelerate BioPharma, which assesses the value of source document verification (SDV) in a risk-based approach to clinical trial site monitoring.

Using robust operational data available through the Medidata Clinical Cloud®, the joint analysis explored the relative contribution of SDV—the process by which data within a case report form (CRF or electronic CRF) is compared to the original source of information—to overall clinical data quality. Results of the analysis revealed that only 1.1% of total site-entered eCRF data are corrected as a result of SDV, confirming that SDV has a minimal impact on overall data quality. Additionally, when compared to SDV, the analysis showed that central monitoring activities and source data review (SDR)—a process that involves checking the quality of the source data, reviewing protocol compliance and ensuring critical processes and source documentation are adequate—are of relatively higher overall value, supporting the conclusion that SDV should not be the primary data quality control method used in clinical trials.

The analysis was published by DIA's Therapeutic Innovation and Regulatory Science journal.