Assessing Causal Relationship (Relatedness Sample Clauses

Assessing Causal Relationship (Relatedness. Solicited adverse events of vaccination site reactions will be considered causally related to study treatment. For all other adverse events, the Investigator and the Sponsor (the local Medical Monitor) will determine a causal relationship to the study vaccine. A number of factors will be considered in making this assessment, including: 1) the temporal relationship of the event to the administration of the study vaccine 2) whether an alternative aetiology has been identified and 3) biological plausibility. Causality of all adverse events should be assessed by the Investigator using the following question: • YES (related): There is a reasonable possibility that the study vaccine contributed to the adverse event • NO (not related): There is no reasonable possibility that the adverse event is causally related to the administration of the study vaccine. There are other, more likely causes and administration of the study vaccine is not suspected to have contributed to the adverse event The Principal Investigator and the local Medical Monitor both determine causality. It is expected that communication and consultation may occur in the assessment of the causality of adverse events. Every effort should be made by the Investigator to determine the existence of any pre-existing conditions (e.g. headache in adults or rashes in infants on study Day 0 with onset prior to study vaccination) that must be taken into consideration when assessing causal relationship of an adverse event. Pre-existing conditions should be recorded in the eCRF as baseline history and substantiated by appropriate source documentation. Intermittent conditions such as headaches in adults or irritability in infants may not be present on study Day 0 but may represent an adverse event if the intensity or duration of the event is worse than usual following study vaccine.