Serious Breach reporting replaces Protocol Deviation/Violation reporting.
A Serious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:
- The safety or rights of a research participant, or
- The reliability and robustness of the data generated in the research project.
It is the responsibility of the Principal Investigator (or delegate) to report any suspected breaches to the Sponsor within 72 hours.
It is the responsibility of the Sponsor to determine whether any suspected breach meets the definition of a Serious Breach.
The Principal Investigator (or delegate) must notify the Research Governance Officer, Ethics Committee Secretariat of any Serious Breach at a Peter Mac site within 72 hours of the Sponsor notifying the Principal Investigator (or delegate) that a Serious Breach has occurred at a Peter Mac site.