Recording and Reporting Adverse Events. For the purpose of AE recording, the study period is defined as the time period from surgery through discharge from the hospital. All AEs will be reported to 7D Surgical. Any reported AE that occurs after the study follow-up period (regardless of time after study participation) will be assessed for its relationship to the patient’s participation in the study. If an AE occurs after the study follow-up period and is considered by the investigator to be possibly related to study participation, it must be recorded and reported.
Recording and Reporting Adverse Events. For the purpose of adverse event recording, the study period is defined as that time period from signature of the informed consent form through the end of the final assessment. All adverse events that occur during the study period must be recorded on the CRF, regardless of the severity of the event or judged relationship to the study drug. For serious adverse events, the Serious Adverse Event Transmittal Form must also be completed and the serious adverse event reported immediately (see section 7.1.5). Any reported serious adverse event that occurs after the study follow-up period (regardless of time after study participation) will be assessed for its relationship to the study drug or to the patient’s participation in the study. If a serious adverse event occurs after the study follow-up period and is considered related to the study drug or a study procedure by the investigator, it must be recorded on the Serious Adverse Event Transmittal Form and reported immediately. At each contact with the patient, the investigator must query the patient for adverse events by asking an open-ended question such as, “Have you had any unusual symptoms or medical problems since the last visit? If yes, please describe.” All reported or observed signs and symptoms will be recorded individually, except when considered manifestations of a medical condition or disease state. A precise diagnosis will be recorded whenever possible. When such a diagnosis is made, all related signs, symptoms, and any test findings will be recorded collectively as a single diagnosis on the Serious Adverse Event Transmittal Form and on the CRF. The clinical course of each adverse event will be monitored at suitable intervals until resolved or stabilized, until the patient is referred to the care of a local health care professional, or until a determination of a cause unrelated to the study drug or study procedure is made. The onset and end dates, duration, action taken regarding study drug, treatment administered, and outcome for each adverse event must be recorded on the CRF. The relationship of each adverse event to study drug treatment and study procedures, and the severity and seriousness of each adverse event, as judged by the investigator, must be recorded as described below.
