Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
Background. Electronic health record-to-electronic data capture (EHR-to-EDC), commonly referred to as eSource, has emerged as a transformative approach for reducing manual data transcription, improving data quality, and decreasing operational burden in clinical trials. While numerous implementation studies have demonstrated promising operational benefits, broader adoption has been constrained by the lack of standardized methodologies capable of generating reproducible and comparable evidence across sponsors, investigational sites, and technology platforms. To address this gap, the European Institute for Innovation through Health Data (i~HD) eSource Scale-Up Task Force developed a harmonized key performance indicator (KPI) framework together with standardized methodologies for measuring implementation outcomes. This study presents the first multi-site validation of the Task Force's standardized clinical research coordinator (CRC) Satisfaction methodology.
