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
- The reliability and robustness of the data generated in the research project
It is the responsibility of the Sponsor to determine whether any suspected breach meets the definition of a serious breach.
Third parties may report a serious breach directly to the HREC in the following situations:
- The investigator/institution has good evidence that a serious breach has occurred, but the sponsor disagrees with their assessment and is unwilling to notify the HREC
- The investigator/institution has become aware that the sponsor may have committed a serious breach
The items below required to be submitted to the Peter Mac HREC by the Sponsor (or delegate) will be acknowledged by the Peter Mac HREC.
The procedure to be followed is provided in the below table:
|
Reporting party |
Report required and timeline |
Supporting information required |
|---|---|---|
|
SPONSOR or delegate |
Serious breaches should be notified to the HREC within 7 calendar days of the sponsor confirming that a serious breach has occurred |
Details of the serious breach Impact of the serious breach on any of:
Details of any action taken to date:
|
|
SPONSOR or delegate
|
Notify the reviewing HREC if a serious breach leads to the closure of a site |
Reason for closure of site Ongoing plan for site participants Implication for other sites, if any |
|
Third party |
Serious breaches can be reported directly to the reviewing HREC |
Details of the serious breach Impact of the serious breach of any of:
|