Protocol Deviation and Violation

Research » Post Ethics & Governance Approval » Protocol Deviation and Violation

Protocol Deviation and Violation

A protocol violation is a failure to comply with the study protocol as approved by the Ethics Committee. A violation is a serious non-compliance with the protocol that can affect participant safety & integrity of the study.

NH HREC Approval: Submit to NH HREC AND lodge a Riskman if there was a real or potential increase in risk to NH participants’ safety

Lead HREC Approval: Concurrent submission to the HREC and the research governance office should occur if the protocol impacts on the overall conduct of the trial or the patients enrolled at Northern Health. Forward to the RGO the Lead HREC acknowledgment/response when received. Otherwise submit to RGO with notification from Lead HREC.

A protocol deviation is a less serious non-compliance with the approved study protocol and generally does not impact on participant safety.

NH HREC Approved: No need to submit unless the deviation impacts on patient safety and/or affects the integrity of the study, ie: endpoint/s

Lead HREC Approved: As above.

Click on the link and scroll to the bottom of the page to download the HREC Amendment Form template.