Solicited Sources of Individual Case Safety Reports

Solicited Sources of Individual Case Safety Reports refer to structured data collection systems used for the purpose of gathering safety information. These systems include various sources such as clinical trials, patient registries, post-authorization named-patient use programs, patient support initiatives, disease management programs, surveys of patients or healthcare providers, and data collection efforts related to drug efficacy or patient compliance.

It’s essential to note that, in the context of safety reporting, solicited reports differ from spontaneous reports. Solicited reports are generated from organized studies and programs, and as such, they should undergo a thorough causality assessment by a healthcare professional or the marketing authorization holder. This assessment is critical to determine the relationship between the reported adverse events and the medication, ensuring that any safety concerns are appropriately evaluated and managed.