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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... Read more

Participating organisations in the National Mutual Acceptance scheme may be added to the ethical approval of a project reviewed by the Peter Mac Ethics Committee. See the listing of the participating organisations under the... Read more

Administrative amendments can be reviewed and approved by the Human Research Ethics and Governance Office and can be submitted at any time. Examples include change of investigators/sponsor; update to contact details;... Read more