Inpatient hospitalization or prolongation of existing hospitalization. (NCI, DCP uses admission or stay (including emergency room) equal to or greater than 24 hours as the definition of hospitalization. Exceptions are hospitalization for treatment of a pre-existing condition, outpatient surgery, planned/elective procedures, and procedures described in the protocol [e.g., pharmacokinetic sampling, surgery] even if the hospital stay is of the described length; however, it does include events resulting from a protocol procedure that fulfill other serious outcome e.g., criteria, prolonged hospitalization or A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect. Important medical event, specify. Indicate the reason for selecting this outcome. (Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed above). Outcome of Event (at time of report): Enter the outcome of the event by marking ONE of the following: adverse event ended. “Resolved”—The If resolved, please provide the resolution date in MM/DD/YYYY format. adverse event has not ended but is “Improved”—The improving. adverse is continuing at the “Unchanged”—The same severity. adverse event worsened. “Worse”—The Available”—Mark if the outcome of the SAE is “Not currently unknown. adverse event ended with death. “Fatal”—The If fatal, enter the date of death in MM/DD/YYYY format. Cause of Death—Enter the reason for the participant’s death. If the cause of death is unknown, enter this information. Autopsy performed—Mark for yes, for no, or “Y” “N” “unknown”.
Inpatient hospitalization or prolongation of existing hospitalization. (NCI, DCP uses admission or stay (including emergency room) equal to or greater than 24 hours as the definition of hospitalization. Exceptions are hospitalization for treatment of a pre-existing condition, outpatient surgery, planned/elective procedures, and procedures described in the protocol [e.g., pharmacokinetic sampling, surgery] even if the hospital stay is of the described length; however, it does include events resulting from a protocol procedure that fulfill other serious outcome criteria, e.g., prolonged hospitalization or A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect. Important medical event, specify. Indicate the reason for selecting this outcome. (Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed above). Outcome of Event (at time of report): Enter the outcome of the event by marking ONE of the following: “Resolved”—The adverse event ended. If resolved, please provide the resolution date in MM/DD/YYYY format. “Improved”—The adverse event has not ended but is improving. “Unchanged”—The adverse is continuing at the same severity. “Worse”—The adverse event worsened. “Not Available”—Mark if the outcome of the SAE is currently unknown. “Fatal”—The adverse event ended with death. If fatal, enter the date of death in MM/DD/YYYY format. Cause of Death—Enter the reason for the participant’s death. If the cause of death is unknown, enter this information. Autopsy performed—Mark “Y” for yes, “N” for no, or “unknown”.
DCP_Consortia_SAE_Instructions.docx