SSA Multi and Single Site Projects - Progress Reporting & Monitoring

A condition of authorisation of all projects authorised by Western Health is that an annual progress report must be submitted by the Principal Investigator (PI). Human Research Ethics Committees (HRECs) are required to monitor research in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007).　 A condition of approval and site authorisation of all projects approved by a HREC is that a report of project progress is submitted annually by the PI.

Click here for the Progress Report SSA Summary Guide

Single submission date

The Office for Research has streamlined the timeframes for submitting annual progress reports and self-audit forms by implementing the same annual due date for all projects. This change has been in effect since 2022. Progress reports for all projects are due on 01 May each year. Therefore, annual progress reports are no longer due by the anniversary of HREC approval, but due on 01 May each year.

We also ask that investigators submit the final site report with the annual progress report to this deadline unless an acknowledgement is required earlier.

Why a single due date for progress reports?

A single due date for all progress reports is easy for investigating teams to remember. In the past teams have forgotten to submit progress reports thus jeopardising the ethics Approval and SSA authorisation status of their study.

A single due date also improves reconciliation and reporting by the Office for Research.

Reporting Period

The reporting period is for the twelve months preceding the annual due date which is 01 May. i.e. May 2024 to May 2025.

Note: Annual Progress Reports for projects that have been approved in January – April in any year do not need to be submitted until 1 May the following year.

Annual Progress Reports

An annual progress report and self-audit should be submitted to the Office for Research by 01 May every year. Continued ethical approval of a project is contingent upon the Office for Research receiving an annual progress report before the anniversary of HREC approval or as specified by the HREC. A failure to do so may result in withdrawal of ethical approval.

How to Submit a Site Progress Report to WH

The site Principal Investigator (PI) should complete and submit a Site Progress Report via　Ethical Review Manager (ERM)

Obtain signature/s via ERM

Upload the following document as supporting documents on ERM:

WH Self-Audit form (download this form on right hand side links)

Note: See the WH ERM Post Authorisation Submissions Guide for further ERM Submission details (download from right hand side links).

Note: Some HRECs may not choose to use the ERM/Department of Health and Human Services (DHHS) template for the combined HREC progress reports. If this is the case, it is acceptable to provide a copy of the report acknowledged by the reviewing HREC using their preferred template, but researchers are still required to create and submit a "Site Progress Report" via ERM reporting Western Health site information for governance acknowledgement.

Failure to submit progress reports may result in suspension of the study and audit investigation from the Office for Research.

Acknowledgement of submission and ongoing authorisation

The Office for Research will acknowledge receipt of the report through an email generated from ERM with attached acknowledgment letter.

Research teams should file the acknowledgement email/s in the Investigator site file as evidence that the project has been approved for a further 12 months.

Final Reports

A final report and self-audit form is required when a study is complete. The Office for Research asks that the final report be submitted by 01 May with the last annual progress report. However, the final report can be submitted prior to this date if acknowledgement is required earlier.

How to Submit a Site Final Report to WH

The local site Principal Investigator (PI) must provide the Coordinating Principal Investigator (CPI) with information to allow them to complete either a Site Closure report or a Project Final report for the reviewing HREC:

A Site Closure Report will be completed by the CPI if an individual site is closed, and the study continues at other sites.

A Project Final Report will be completed by the CPI if the study has been completed at all sites.

Once the Project Final Report or Site Closure Report has been reviewed by the reviewing HREC, a formal acknowledgement will be sent to the CPI.

The site PI should then complete and submit the report via　Ethical Review Manager (ERM) using the Site Notification Form

Make sure in the section "For what purpose is this report being submitted?" that you specify "Final Report" or "Site Closure Report"
Obtain signature/s via ERM
Upload the following documents as supporting documents in ERM:

HREC Final Report/Site Closure Report (as submitted to reviewing HREC)
Reviewing HREC acknowledgment of Final Report/Site Closure Report

WH Self-Audit form (download this form on right hand side links)

What does "completion mean?"

For commercially sponsored clinical trials - a study is considered complete once the closeout visit has been completed.
For investigator initiated clinical trials - a study is considered complete once the last patient has completed follow-up and the data have been analysed.
For other research projects - a study is considered complete once data collection is complete and there is no further contact with patients or access to medical records or other sources of personal health or information and the data have been analysed.

Acknowledgement of final report

The Office for Research will acknowledge receipt of the report through email generated from ERM with attached acknowledgement letter.
Research teams should file the acknowledgement email/s in the Investigator site file as evidence that the final report has been acknowledged.