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Serious Breaches, Suspected Breaches and Deviations


Serious Breach 

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.

Within 72 hours of being notified of the serious breach (confirmed by the sponsor), the Principal Investigator (PI) must report to the institution a serious breach occurring at a local site.

Within 7 days of confirming the serious breach, the sponsor must use this form to report a confirmed serious breach occurring during the conduct of a clinical trial to the CALHN HREC.

Suspected Breach

A report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor.

This Research Suspected Breach Report Form should be used when a third party (e.g. institution/individual) wishes to report a suspected breach of Good Clinical Practice or the protocol directly to the CALHN HREC without reporting through the sponsor.


Any breach, divergence, or departure from the requirements of good clinical practice or the clinical trial protocol.

The report must be completed by the lead Principal Investigator (PI) in collaboration with the sponsor (where applicable) when reporting a deviation from the protocol or GCP occurring in a clinical trial or health/medical research project approved by the CALHN Human Research Ethics Committee (HREC).

Deviations arising from investigational medicinal products or investigational medical devices do not require reporting to CALHN Research Services unless they are considered serious breaches in which case they must be reported using the Research Serious Breach Report Form.

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