Adverse Event Clinical Research Implementation Guide (PSS-2171)

Adverse events (AE) are tracked and evaluated as part of the clinical research process in a research study, as the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In the research setting, an Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.

The IG (one based on R4 and one on R5) will model the data elements to support the workflow for collecting and reporting serious and non-serious AEs in clinical research to meet the need of regulatory requirements. This will require further profiling and extending the AdverseEvent resource to ensure appropriate representation. Therefore, allowing AE representation in systems, including EMRs and PHRs, transmitted via FHIR to other systems; removing the need to transcribe AE data into secondary clinical trial management systems and improving efficiency for health authority reporting.