DEPARTMENTS OF DEFENCE AND VETERANS’ AFFAIRS HUMAN RESEARCH ETHICSCOMMITTEE

ADVERSE AND SERIOUS ADVERSE EVENT REPORT

It is a condition of ethical approval that Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported to the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC).

This report must be used to notify the DDVA HREC of AEs or SAEs that occur during a research project. For SAEs, the Principal Investigator (PI) must submit this report to DDVA HREC within 72 hours. For AEs, the PI must submit this report within 30 calendar days.

Researchers will also need to include details on AEs and SAEs in their progress and final report.

Completed reports are to be emailed to ddva.hrec@defence.gov.au.

Notes: To check a box electronically, right click on the box, and select “Properties” then mark the “Default value” as “Checked”.

If changes are recommended to the protocol or the Participant Information and Consent Forms the Principal Investigator will need to submit a request for amendment and the revised forms (where appropriate).

Section 1: Project Details Protocol Number: 852-17Project Title: Biomechanical, physiological and psychophysical responses

when wearing an exoskeleton during functional military tasks and duties

Name of PI: PI contact details:

Name of Supervisor/s (for student research):

N/A

Supervisor contact details: N/A

Section 2: Event Details Date: 24/11/17 Description of event (including location and number of participants affected):

Participant got blisters on the posterior aspect of the left and right heel following a 10km pack march at Simpson Barracks.

Has the PI reported the event to the sponsor?

Yes No N/A If no or n/a applicable selected, please indicate why the sponsor was not notified of the event:

Relationship: Suspected related Probably related Unlikely related Not related

Immediate action taken: First aid was applied by the principle investigator during the trial. Following the completion of the trial on the 24/11 the participant was referred to the Regimental Aid Post (RAP) to receive further treatment and advice.

Subsequent action taken and/or required:

Participant was cleared for full duties from the RAP and was advised to monitor symptoms and report back if symptoms worsen.

Outcome: Participant returned to full duties following clearance from the RAP.

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Section 3: Implications Does this event raise any additional safety concerns for participants? Yes No If yes, please provide details. If no, please explain why.

Will there be changes to the research protocol as a result of this event? Yes No If yes, please provide details.

Will there be changes to the Participant Information Sheet or Consent Form as a result of this event? Yes No If yes, please provide details. If no, please explain why. This event does not appear to be a systematic issue and the participant continued to complete all activities without further complaint.

Are there any other issues raised by this adverse event that may have wider implications? Yes No

If yes, please provide details and explain how you will address them.

Section 4: Declaration by Principal Investigator I advise the following (please indicate): Change to the protocol* Yes No

Change to the PICF* Yes No

Previously enrolled participants to be notified Yes No

The study to be stopped. Yes No

If yes, specify the action required:

PI Signature PI Printed Name: Date: 22/12/2017

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DEPARTMENTS OF DEFENCE AND VETERANS’ AFFAIRS HUMAN RESEARCH ETHICSCOMMITTEE

ADVERSE AND SERIOUS ADVERSE EVENT REPORT

It is a condition of ethical approval that Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported to the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC).

This report must be used to notify the DDVA HREC of AEs or SAEs that occur during a research project. For SAEs, the Principal Investigator (PI) must submit this report to DDVA HREC within 72 hours. For AEs, the PI must submit this report within 30 calendar days.

Researchers will also need to include details on AEs and SAEs in their progress and final report.

Completed reports are to be emailed to ddva.hrec@defence.gov.au.

Notes: To check a box electronically, right click on the box, and select “Properties” then mark the “Default value” as “Checked”.

If changes are recommended to the protocol or the Participant Information and Consent Forms the Principal Investigator will need to submit a request for amendment and the revised forms (where appropriate).

Section 1: Project Details Protocol Number: 852-17Project Title: Biomechanical, physiological and psychophysical responses

when wearing an exoskeleton during functional military tasks and duties

Name of PI: PI contact details:

Name of Supervisor/s (for student research):

N/A

Supervisor contact details: N/A

Section 2: Event Details Date: 09 November 2017 Description of event (including location and number of participants affected):

Participant reported pain in the medial right knee, two weeks following the completion of treadmill trials.

Has the PI reported the event to the sponsor?

Yes No N/A If no or n/a applicable selected, please indicate why the sponsor was not notified of the event:

Relationship: Suspected related Probably related Unlikely related Not related

Immediate action taken: Participant was referred to the Regimental Aid Post (RAP) to seek advice from a registered physiotherapist.

Subsequent action taken and/or required:

Participant was cleared for full duties from the physiotherapist and was advised to monitor symptoms and report back if symptoms worsen.

Outcome: Participant returned to full duties following clearance from the physiotherapist.

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Section 3: Implications Does this event raise any additional safety concerns for participants? Yes No If yes, please provide details. If no, please explain why.

Will there be changes to the research protocol as a result of this event? Yes No If yes, please provide details.

Will there be changes to the Participant Information Sheet or Consent Form as a result of this event? Yes No If yes, please provide details. If no, please explain why. This event does not appear to be a systematic issue and the participant continued to complete all activities without further complaint. Are there any other issues raised by this adverse event that may have wider implications?

Yes No If yes, please provide details and explain how you will address them.

Section 4: Declaration by Principal Investigator I advise the following (please indicate): Change to the protocol* Yes No

Change to the PICF* Yes No

Previously enrolled participants to be notified Yes No

The study to be stopped. Yes No

If yes, specify the action required:

PI Signature PI Printed Name: Date: 22/12/2017

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DEPARTMENTS OF DEFENCE AND VETERANS’ AFFAIRS HUMAN RESEARCH ETHICSCOMMITTEE

ADVERSE AND SERIOUS ADVERSE EVENT REPORT

It is a condition of ethical approval that Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported to the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC).

This report must be used to notify the DDVA HREC of AEs or SAEs that occur during a research project. For SAEs, the Principal Investigator (PI) must submit this report to DDVA HREC within 72 hours. For AEs, the PI must submit this report within 30 calendar days.

Researchers will also need to include details on AEs and SAEs in their progress and final report.

Completed reports are to be emailed to ddva.hrec@defence.gov.au.

Notes: To check a box electronically, right click on the box, and select “Properties” then mark the “Default value” as “Checked”.

If changes are recommended to the protocol or the Participant Information and Consent Forms the Principal Investigator will need to submit a request for amendment and the revised forms (where appropriate).

Section 1: Project Details Protocol Number: 852-17Project Title: Biomechanical, physiological and psychophysical responses

when wearing an exoskeleton during functional military tasks and duties

Name of PI: PI contact details:

Name of Supervisor/s (for student research):

N/A

Supervisor contact details: N/A

Section 2: Event Details Date: 21/11/17 Description of event (including location and number of participants affected):

One participant reported muscle pain in the right hip flexor muscles following completion of the trials on the 20/11/17 at Simpson Barracks.

Has the PI reported the event to the sponsor?

Yes No N/A If no or n/a applicable selected, please indicate why the sponsor was not notified of the event:

Relationship: Suspected related Probably related Unlikely related Not related

Immediate action taken: The participant was referred to the Regimental Aid Post (RAP) to receive further treatment and advice from the physiotherapist.

Subsequent action taken and/or required:

Participant placed on restricted duties from RAP on the 21/11/17 and booked for a re-evaluation on the 23/11/17. The participant was cleared for full duties from the 23/11/17 and was advised to monitor symptoms and report back if symptoms worsen.

Outcome: Participant returned to full duties following clearance from the RAP on the 23/11/17.

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Section 3: Implications Does this event raise any additional safety concerns for participants? Yes No If yes, please provide details. If no, please explain why.

Will there be changes to the research protocol as a result of this event? Yes No If yes, please provide details.

Will there be changes to the Participant Information Sheet or Consent Form as a result of this event? Yes No If yes, please provide details. If no, please explain why. This event does not appear to be a systematic issue and the participant continued to complete all activities without further complaint.

Are there any other issues raised by this adverse event that may have wider implications? Yes No

If yes, please provide details and explain how you will address them.

Section 4: Declaration by Principal Investigator I advise the following (please indicate): Change to the protocol* Yes No

Change to the PICF* Yes No

Previously enrolled participants to be notified Yes No

The study to be stopped. Yes No

If yes, specify the action required:

PI Signature PI Printed Name: Date: 22/12/2017

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