Unexpected events (not disclosed in consent form or described as risks in the protocol) or expected events that are determined to be occurring at a significantly higher frequency or severity than expected;
Physically, mentally, or psychologically harmful events – whether observed or reported by participants; and/or
Events related or possibly related to participation in the research.
Any monitoring reports or summary reports of (FROM) an audit indicating non-compliance.
Any protocol deviations, meaning any variation (intentional or unintentional) from an approved study protocol, or deviation from relevant federal regulations or IRB requirements, that may affect the subject’s rights, safety, or well-being and/or the completeness, accuracy, and reliability of the study data.
