Instructions: Use this form for reporting all serious adverse events (SAEs) adverse incidents (AIs), protocol deviations, protocol violation, unanticipated problems, and non-compliance issues.
1.0 Project Details
Lead HREC Name / [INSERT lead HREC name]
HC/Approval Number: / HC[INSERT number]
Approval number (if UNSW is not the lead site): [INSERT number]
Project title: / [INSERT project title]
Date: / [INSERT date]
Re: / [INSERT type of event SAE/AI/Protocol Violation/Protocol Deviation]
Participant ID
(one participant per report) / [INSERT participant ID or leave balnk]
2.0 Reporting Status (only check boxes that apply) (double click to ‘check’ each box)
Initial report / Reported to Sponsor / Reported to Data Safety Monitoring Board (DSMB)
Follow-up to report submitted on [INSERT original report date] / Other: [INSERT explanation]
3.0 Research Study Status (only check boxes that apply) (double click to ‘check’ each box)
Recruitment open, participant(s) enrolled / Recruitment open, no participant(s) enrolled / Recruitment closed, research limited to data analysis only
Recruitment closed, participant(s) enrolled with ongoing study activities / Recruitment closed, research limited to follow-up only / Other: [INSERT explanation]
4.0 Description of Incident
4.1 Summary of the incident, including reason(s) why the incident occurred
[INSERT summary of incident/s]
4.2 Explain whether the incident impacted on the safety or rights of research participants and/or others (e.g. research staff)
[INSERT explanation of impact on participants]
4.3 Explain whether the incident impacted on study integrity (e.g., study data)
[INSERT explanation of impact on study integrity]
4.4 Describe the corrective action plan for each reported incident (this plan must include a description of what steps will be taken to prevent the incident from reoccurring and most plans should address how the actions taken will protect enrolled participants and any follow-up with participants such as providing additional information to and/or re-consenting. If you will be revising any study documents you must submit a modification requestin addition to this report).
[INSERT description of corrective action/s]
4.5Explain whether the event requires changes to the Participant Information Statement and/or to the protocol?(if changes are required, please submit a modification requestin addition to this report).
[INSERT explanation]
4.6 Explain whetherparticipants currently enrolled in the research study will be notified of the event and if so, will they be re-consented
[INSERT explanation]
5.0 Chief Investigator Declaration (double click to ‘check’ each box)
By submitting this adverse event form, I, the Chief Investigator/Centre/Organisation, declare that:
the information contained in this report is true and accurate;
that this project is being conducted in keeping with the conditions of approval of the lead HREC (and subject to any changes subsequently approved);
that I have not received any information in any form from anyone involved in the research to suggest this report does not accurately reflect the information detailed in this report;
that the project is being conducted in compliance with the NHMRC National Statement on Ethics Conduct in Human Research (NHMRC, 2007, revised in 2014) or as amended.
6.0 How to submit this form
The adverse event form must be submitted electronically by the Chief Investigator from his/her work email account to:
UNSW Human Research Ethics Committee (HREC)
Human Research Ethics SAE/Adverse Incident/Protocol Deviation/Protocol Violation Report version dated 30 January 2017