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Reporting FAQs

Do I need to submit to the IRB reports from routine sponsor audits or monitoring visits?

In accordance with IRB policy 10.2, only events that are unexpected AND research-related AND that indicate new or increased risk to subjects or others must be individually reported to the IRB.

If your sponsor audit or monitoring report includes findings that meet these criteria, the events should be reported to the IRB individually, either immediately or within 10 days.

However, if the audit or report returns only findings that do not meet all three of these criteria, the findings should be summarized and reported with the next continuing review. See Reporting to the IRB for more information.

How do I submit sponsor audits or monitoring reports that include multiple studies to the IRB?

If you are reporting findings from an audit or monitoring report that includes multiple studies, do not submit the entire report to the IRB.

Instead, summarize only the finding(s) pertinent to the individual study that the UAMS IRB oversees.

If you submit the entire report, you will have information about several different studies in your study’s file, which could negatively impact study confidentiality and raise questions if the study were to be audited by a government oversight agency such as the U.S. Food and Drug Administration (FDA).