WCG, a provider of clinical research solutions, published the Safety Reference Model. A first-of-its-kind operational guide for handling safety reporting to investigators, ethics committees, and competent authorities, the Safety Reference Model (SRM) was developed in response to the critical need to harmonize safety reporting processes from regulators and across sponsors and CROs, all of which are using different interpretations of high-level regulations in each country with active trials.
 
In developing the Safety Reference Model, WCG’s Avoca Quality Consortium, a collaborative of more than 200 pharma, biotech, CRO, clinical service providers and sites committed to clinical trial quality and execution, gathered the regulatory intelligence in use at companies with a global presence and analyzed the differences in best practices and interpretations across companies over the last 12 months.
 
The resulting SRM is the recommended best practice approach to safety reporting in clinical trials in 125 countries. The SRM provides standardized taxonomy, metadata, and outlines a reference definition of SRM content using standard nomenclature that can be deployed as a manual guide to optimize safety reporting worldwide.
 
“For over 20 years, we have partnered with organizations to optimize their safety processes,” continued Moench. “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 post-marketing. 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.”