Research

Protocol Deviation/Violation

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

Protocol Deviations

 

A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator’s control and that has not been approved by the ethics committee.

Major deviations  which pose a risk to patient safety, or have ethical or significant administrative implications must be reported to the HREC and RGO within 7 days of occurrence.

Major deviations should be submitted using the Serious Breach Report Form. Please outline in the report why the violation occurred and what steps have been taken to rectify the violations. 

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 HREC 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.

Please submit one electronic copy with electronic signatures to EthicsSafetyReports@austin.org.au using this email template.

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


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Protocol Violations

A protocol violation is any change, divergence, or departure from the study design or procedures of a research protocol that affects the participant's rights, safety, or well being and/or the completeness, accuracy and reliability of the study data.

Protocol violations which pose a risk to patient safety, or have ethical or significant administrative implications must be reported to the HREC and RGO within 7 days of occurrence.

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 Violations should be submitted using the Serious Breach Report Form. Please outline in the report why the violation occurred and what steps have been taken to rectify the violations. 

Please submit one electronic copy with electronic signatures to EthicsSafetyReports@austin.org.au using this email template.

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

 

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Submitting your Protocol Deviation/Violation:

1.     Please submit one electronic copy with electronic signatures to EthicsSafetyReports@austin.org.au using this email template.

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

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