An<unk>  <unk>  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<unk>  <unk>  can therefore be any unfavourable and 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.<unk> s in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to local ethics committee.<unk> s categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious<unk> s are merely documented in the annual summary sent to the regulatory authority. The sponsor collects<unk>  reports from the local researchers, and notifies all participating sites of the<unk> s at the other sites, as well as both the local investigators' and the sponsors' judgment of the seriousness of the<unk> s. This process allows the sponsor and all the local investigators access to a set of data that might suggest potential problems with the study treatment while the study is still ongoing.
Adverse event
Sentinel event
Unwarranted variation
Adverse outcome pathway
Mass-casualty incident
Inclusion and exclusion criteria
Interventionism 
Conflict procedure