WCG Publishes Safety Reporting Reference Guide
WCG has unveiled its new Safety Reference Model (SRM), an operational reference guide to be used for safety reporting to investigators, regulators and ethics committees.
Over the past 12 months, WCG’s Avoca Quality Consortium, which encompasses more than 200 sites, sponsors, CROs, and service providers, evaluated the differences in best practices and interpretations across companies and used these insights to develop the SRM. The mission of this new guide is to bring differing safety reporting strategies in step across industry and improve trials across the board, according to Terri Moench, president of WCG Research Solutions.
“Every company we’ve worked with has had different approaches to managing safety regulations and best practices. This lack of standardization and harmonization has led to increased operational costs, greater site burden and decreased patient safety, as important signals are missed or detected only in postmarketing,” Moench said. “It’s been our goal to move toward an industry-approved approach to safety reporting that minimizes costs and site burden while ensuring safety and inspection readiness.”
According to WCG, the newly published SRM encompasses best practices in safety reporting for 125 countries, offering standardized taxonomy, metadata and reference definitions.