With the release of ICH GCP (Good Clinical Practice) E6(R3), sponsors and investigators are revisiting how they define and handle protocol deviations. While GCP R3 emphasizes the concept of “Important Protocol Deviations” (IPDs), it does not explicitly reference “Serious Breaches” (SBs).
However, section 3.12.2 states: “Where the sponsor identifies issues that are likely to significantly impact the rights, safety or well-being of the trial participant(s) or the reliability of trial results (i.e., serious noncompliance), the sponsor should notify the regulatory authority and/or IRB/IEC, in accordance with applicable regulatory requirements, and/or investigator, as appropriate.”
Moreover, certain jurisdictions (e.g., the UK, EU/EEA Member States under EU CTR 536/2014, Australia, Singapore, Serbia) do require sponsors to identify and promptly report Serious Breaches