SSA Projects - Progress Reporting & Monitoring
A condition of authorisation of all projects authorised by the 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.
Changes from 2022
Click here for the Progress Report SSA Summary Guide
Single submission date
The Office for Research is streamlining the timeframes for submitting annual progress reports and self-audit forms by implementing the same annual due date for all projects. This change is effective from 2022. Progress reports for all projects are now due on 01 May each year. Meaning, annual progress reports will no longer be due by the anniversary of HREC approval.
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 implement a single due date for progress reports?
The Office for Research envisages that a single due date for all progress reports will be easier for investigating teams to remember. In the past teams have forgotten to submit progress reports thus jeopardising the ethics status of their study. With this change we aim to avoid this confusion.
A single due date will also improve 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 2021 to May 2022.
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.
An annual progress report and self-audit should be submitted to the Office for Research by 01 May every year (Starting 2022). 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.
Annual Progress Reports
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)
- Send an email notification to [email protected] to initiate review. The email must include the following details:
- ERM Project ID and HREC Reference number
- Project title
- Type of submission (e.g. Progress Report for 2021-2022)
- Date of submission made on ERM
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 email and ERM.
- 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.
- 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)
- Send an email notification to [email protected]to initiate review. The email must include the following details:
- ERM Project ID and HREC Reference number
- Project title
- Type of submission (e.g. Final Report/Site Closure)
- Date submission made on ERM
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 and ERM.
- Research teams should file the acknowledgement email/s in the Investigator site file as evidence that the final report has been acknowledged.
Contact for queries:
Ms Saritha Bingi
Ethics & Governance Officer
03 8395 8071
[email protected]
