The ultimate goal of clinical trial safety monitoring is to evolve medically relevant safety label information for the product under development.
Safety data from ongoing clinical trials has a direct impact on the safety and clinical care of patients enrolled in these trials. The objective of collecting safety data from clinical trials is early detection of important safety signals, protecting patients from unnecessary risks, and developing the safety profile of the drug contributing to its benefit-risk assessment. Monitoring patient safety is an integral and critical part of the clinical trial process.
