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.
Minor protocol deviations which do not carry significant ethical / administrative implications or consequences do not need to be reported to the HREC. However, all such deviations must be recorded in the study file and reported to the sponsor.
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.
Major deviations and protocol violations which pose a risk to patient safety, or have ethical or significant administrative implications must be reported to the HREC and the Sponsor soon as possible.
How to submit protocol deviations and violations
Submit the form, signed by the PI by emailing it to HrecCorrespondence@mh.org.au.
Name the file and the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2015.001 protocol violation 1 Jan 2015).
An automatic email reply will be sent to you to confirm receipt of the correspondence by the Office for Research.
Any queries and/or the approval letter will be emailed to you by the Office for Research in due course.