Adverse event reporting and harms {22}
death, illness or injury, ACLF, heart failure
ADVERSE EVENTS, ADVERSE EVENT, EVENT, CHRONIC DISEASES, ADVERSE EVENT, HEPATIC ENCEPHALOPATHY, EVENTS, DISEASES, ISCHEMIC HEPATITIS
Adverse events are any untoward medical occurrences, unintended diseases or injuries, or any untoward clinical signs including abnormal laboratory findings in participants, users, or other persons in the context of this study, whether or not related to the investigational or control device and procedure. For users and other persons, adverse events are restricted to related adverse events. All adverse events must be specified in the study adverse event case report form. Severity and putative relationship to study devices or procedures should be noted. Investigational sites are responsible for adverse event reporting to the sponsor. Device complaints have to be reported directly to the manufacturer. Adverse device effects will be reported to the sponsor (ZKS Jena) quarterly.Serious adverse events are any untoward events that occur during this study, which lead or possibly might lead, directly, or indirectly to death or serious deterioration in the state of health, life-threatening illness, injury, or permanent impairment of a body structure or a body function including chronic diseases, or prolonged hospitalization, or medical or surgical interventions to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function of a participant, user, or other persons whether or not related to the investigational or control device and procedure. For users and other persons, serious adverse events are restricted to related serious adverse events. In the event of severe adverse events, investigational sites must immediately deliver a report to the sponsor (center for clinical studies [ZKS] Jena, via fax within 24 h of knowledge). Any required follow-up information must be provided as soon as possible. All severe adverse events that are still ongoing at 12 months have to be followed up until resolved or until investigator confirms that no further improvement or deterioration is expected. The same applies to adverse events of special interest (AESIs) if not already fulfilling the definition of a SAE. AESIs are adverse events defined as especially critical for patient safety within this study: ischemic hepatitis, ACLF, heart failure, hepatic encephalopathy, and development of post-contrast (PC)-AKI.Incidents of any medical device that have occurred in Germany, irrespective of a clinical study, have to be reported to the competent authority by the device user. The sponsor will send a quarterly report with the cumulative severe adverse event assessment to the Federal Institute for Drugs and Medical Devices (BfArM) and ethical committees involved as required.The trial may be terminated prematurely if the DSMB raise concerns about the safety of the medical device.