Sarcouncil Journal of Biomedical Sciences

Abstract: Real-world evidence (RWE) from electronic health records, registries, claims, and other observational sources is increasingly utilized to support clinical trial design, external control arms, and regulatory decision-making. However, inconsistent governance, variable data quality, and limited provenance documentation hinder regulatory acceptance and auditability. This review synthesizes current regulatory expectations, data-quality frameworks, and oncology-specific challenges, alongside an operational “audit-ready” framework that integrates governance, technical controls, and documentation to ensure trustworthy RWE in oncology. Key recommendations include mandated provenance capture, adoption of common data models, and standardized data-quality assessment with pre-defined thresholds for audit packages submitted to regulators.