Investigators and sponsors are instructed to report unexpected (only if related or possibly related) adverse events, protocol deviations, subject complaints that indicate increased risk, audit reports, summaries of interim analyses and/or DSMB reports, new publications and labeling changes, and other events that may represent unanticipated problems involving risks to participants and others to Goodwyn Institutional Review Board within 10 working days.

More information about IRB reporting changes can be found by selecting the Background button below.

To report, select the appropriate button below: