Severe Adverse Event Reporting
ADVERSE EVENT REPORTING
Documentation of a serious adverse event (SAE) or unexpected adverse event (UAE) is a requirement of all study protocols. These events must be reported to the Institutional Review Board. Documentation of a SAE, including death due to any cause, is required regardless of whether or not the SAE is associated with the study treatment.
Adverse Event (AE) – an adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, medical device, or study-related procedures whether or not considered casually related to the product. An undesirable medical condition can be symptoms (e.g. nausea, chest pain), signs (e.g. tachycardia, enlarged liver) or abnormal results of an investigation (e.g. laboratory findings, electrocardiogram). In clinical studies an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered.
Serious Adverse Event (SAE) – One that is fatal, life threatening, or permanently disabling; one that requires or prolongs hospitalization; or results in a congenital anomaly; cancer; or drug overdose or requires treatment to prevent these problems.
Unexpected Adverse Event (UAE) – One that is not identified in nature, severity, or frequency in the package insert for the medication.
EVALUATION OF SAE/UAE:
Usually transient, requiring no special treatment, does not interfere with the patient’s daily activities
Traditionally introduces a low level of inconvenience or concern to the patient, may interfere with daily activities, usually ameliorated by simple therapeutic measures.
Interrupts a patient’s usual daily activity; traditionally require systemic drug therapy or other treatment.
Relationship to treatment:
Indicates that there is little or no chance the study treatment caused the reported event. Other conditions, including concurrent illnesses, progression or expression of the disease state, or a reaction to a concurrent medication are examples that may explain the reported event.
Indicates that the association of the event with the study treatment is unknown, however, the event is not reasonably attributed to any other condition
Indicates that a reasonable temporal sequence exists between the event and treatment administration, and, based upon the investigator’s experience, the association of the event with the study treatment seems likely.
PROCESS FOR REPORTING SAE’S/UAE’S
Submit a completed Serious/Unexpected/Adverse Event Report form (enclosed) or a copy of a completed sponsor report form, including all applicable supporting documentation, and the current number of events to the current number of study subjects to the IRB for review. This should be received within 10 days of receipt in the investigators office. Add an acknowledgement field to the bottom of the cover letter we can sign and fax back to you as proof of receipt.
In the event of termination of the study, the sponsor will also be notified by the International Cellular Medicine Society.