FACT SHEET Risk-Based Approach to Clinical Development PRA’s risk-based approach to clinical development represents a comprehensive approach to clinical study risk management and includes centralized monitoring and advanced analytics as an integral element. It aligns with ICH E6 (R2) regulatory guidance, with a foundation of ensuring subject safety, GCP compliance, and data quality. Executive Summary Conducting 100% source data verification doesn’t ensure data quality and patient safety and isn’t an efficient use of resources and time. Industry regulators have issued guidance—including ICH E6 (R2)—outlining the requirements for employing a targeted, risk-based approach for conducting and monitoring clinical trials. This approach includes an upfront risk assessment, identification o

Join for free to read