Research

Protocol Deviation/Violation

This type of submission applies when a protocol deviation or protocol violation has occurred.

 

A protocol violation is any change, divergence, or departure from the study design or procedures defined by the protocol that pose a risk to patient safety, or have ethical or significant administrative implications must be reported to the HREC using the HMR PD Form (NHMRC template).

Protocol Violations must be reported to the lead HREC and Austin Health Office for Research within 7 days of occurrence. Once the lead HREC acknowledgement has been received it must be submitted to the Austin Health Office for Research.

Protocol deviations which do not carry significant ethical / administrative implications or consequences are requested to be logged on a spreadsheet and reported, per trial protocol to the Austin Health Office for Research quarterly on the following dates:

1.     1st March

2.     1st June

3.     1st September

4.     1st December

Protocol Deviatation should also be submitted to the lead HREC as per their local requirements. Once the lead HREC acknowledgement has been received it must be submitted to the Austin Health Office for Research.

Protocol Deviations & Protocol Violations should be submitted to the Austin Health Office for Research using the Protocol deviation or violation report form. Please outline in the report why the violation occurred and what steps have been taken to rectify the violations. 

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Submitting your Protocol Deviation/Violation:

1.     Please submit one electronic copy with electronic signatures to EthicsSafetyReports@austin.org.au

[Please title the subject of the email "Protocol Deviation/Violation for [Austin Health Project Number & SERP/Protocol number (if applicable)]”

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