Definition of Serious Adverse Sample Clauses

Definition of Serious Adverse. Event (SAE) A serious adverse event (SAE) is any untoward medical occurrence or effect that led to one of the following outcomes: · death of a patient, user or other person · serious injury of a patient, user or other person Serious injury (also known as serious deterioration in state of health) is either: · a life threatening illness or injury * · permanent impairment of a body function or permanent damage to a body structure† · a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure
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Definition of Serious Adverse. EVENTS (SAES) All serious adverse events during the study period, whether or not considered to be related to study treatment must be reported to the respective CRO that is managing the site within 24 hours or, at the latest, on the following working day. At the time of the initial report, as much information as possible should be provided: patient allocation number, treatment, study identifiers, the phase of treatment during which the event occurred, a description of the event, its date of onset and current status; the start date, the start time, whether this treatment has been discontinued; the reason why the event is regarded as serious; the current assessment of causality, investigator's name and address. The investigator must fax the SAE form within the next 24 hours if it is not provided at the time of the initial notification. Any other diagnostic information, which will assist the understanding of the event, should be provided at this time. The study patient must be followed until the final outcome of the SAE is known, including any which are still ongoing at the end of the study. Significant new information on the SAE, and the final outcome, must be supplied promptly to the respective CRO that is managing the site. This should be done in the same way and time frame as for the original notification, using the SAE form and identifying this as follow up information. The investigator must report promptly any SAEs, which may be detected after the study, and are suspected to be related to study treatment. Investigators must report all SAEs to the IRB according to their institutional policy.
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