Protocol deviation/violation form that was submitted to the sponsor (if available).
Adverse Event Reporting
Please see the Unanticipated Problem Reporting-Adverse Events guideline document to determine which SAEs require reporting to the REB. If the submission does not meet the reporting requirements for events that constitute Unanticipated Problem, the submission will be withdrawn. Please submit your report in ROMEO.
Serious, unexpected adverse events or reactions regardless of causality for participants enrolled at the Local site;
Report Due: Within seven (7) days of discovery of the event or reaction;
Serious, unexpected adverse reactions or events related to the study intervention that occur at all non-local or external sites;
Report Due: Within 30 days of being notified of the event or reaction;