The IB must be updatedas new significant safety information emerges.
ICH E6(R2) 7.3:“The sponsor should revise the IB as soon as new, significant information becomes available.”
ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.
A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.
Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.
Thus, the correct answer isB (SUSAR report).
[References:, ICH E6(R2), §7.3 (Updating the Investigator’s Brochure)., ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)., , , , ]
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