Comment from Anonymous
AnonymousOtherIndividual
Summary: The commenter is seeking clarification on whether the proposed guidance requires all IND safety reports to be reported to Institutional Review Boards (IRBs). They note that the current guidance requires a determination of whether a Suspected Unexpected Serious Adverse Reaction (SUSAR) constitutes an Unanticipated Problem (UP), and they are concerned about the potential impact of reverting to reporting all reports.
Section 6 appears to state that all IND safety reports are unanticipated problems and be reported to the IRB. This would be a significant change to the existing guidance whereby there was a determination of whether a given SUSAR was an Unanticipated Problem, as some but not all SUSARs are UPs. This minimized reported to IRBs who complained about receiving all IND safety reports. Clarification of whether intended to revert to reporting the all IND safety reports to IRBs or there is still some determination of which SUSARs are UPs - ie those tied to some risk management action.