Annual progress reporting is a condition of ongoing Human Research study approval

Progress report ERM issues

The Office for Research has received feedback from researchers and coordinators outlining issues with Ethics Review Manager (ERM) and the submission of reports. The most prevalent issues that ERM users experienced are items that the Office for Research cannot provide assistance with as we have no platform control of the ERM database. However, we have provided a table below to assist you on how to manage the most common issues experienced by ERM users.

Project Origin

Issue

Action Required

Single-site RMH approved project not initially submitted on ERM

Unable to find project on ERM

Create a Legacy Application Form (Section 12, pp. 72-3) as per the ERM Applicant User Guide

Projects that were not initially submitted on ERM and have since been relocated to ERM

Unable to find project on ERM

Contact the Coordinating Office

Projects with changes of personnel

Current personnel do not have access to project on ERM

Contact the Coordinating Office. The OFR cannot allocate access of any projects to personnel

Projects that have Minimal Data Forms (MDF)

Cannot generate a final report as the form is not in the dropdown for the SSA

For these projects only - compete a final report using the old (orange) form. Upload the final report as a supporting document to the site report along with HREC acknowledgement of site closure

Resources

  • ERM Applicant User Guide: This useful document contains instructions on how to add Sub-Forms (e.g. progress reports, final reports) to the project.
  • Contact the Coordinating Office in the first instance if:
    • you are having difficulty accessing your project's Ethics or SSA form on ERM; and/or
    • you are having difficulty creating Sub-Forms
    • Coordinating Office telephone: 0408 274 054 or email: multisite.ethics@ecodev.vic.gov.au

    Annual progress reports

    Annual Progress Reports must be submitted by 31 March each year.

    Reporting period

    The reporting period is for the twelve months preceding the annual due date which is 31 March each year. i.e. March 2021 to March 2022.

      Ongoing HREC approval

      Continued ethical approval of a project is contingent upon the Office for Research receiving an annual progress report by the 31 March due date. A failure to do so may result in withdrawal of ethical approval.

      Help! Which progress report do I need to complete?

      1. For multi-site studies the answer to this question will depend on whether the RMH HREC was the reviewing HREC and/or whether RMH is/is not a participating site. See below for the different scenarios and what is required.
      • Where the RMH HREC is the reviewing HREC and RMH is a participating site, submit:
        • Site Progress Report and
        • Project Progress Report
      • Where the RMH HREC is the reviewing HREC but RMH is not a participating site, submit:
        • Project Progress Report
      • Where the RMH HREC is not the reviewing HREC but RMH is a participating site, submit:
        • Site Progress Report. Also forward a copy of the completed form to the Coordinating Principal Investigator of the project.
      1. For all other studies
      • Complete the Site Progress Report.

      Final reports

      Investigators are required to submit a final report and, where applicable, a self audit report for research. See below for explanation:

      • A final report is required when a study is complete. The Office for Research asks that the final report be submitted by 31 March with the last annual progress report. However, the final report can be submitted prior to this date if acknowledgement is required earlier.
      • For studies with an RMH site, complete a self-audit annually using the Site Audit Report for Research form and submit it with the Progress Report. For further information regarding auditing of research at RMH refer to the Auditing research projects page of the website

      What does 'completion' of a project 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 all 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.

      Instructions for submitting progress and final reports

      1. Via Ethics Review Manager (ERM), complete the relevant Progress Report and, only if the study is complete, the Final Report.
      2. Obtain appropriate signatures via ERM
      3. Submit the report/s via ERM

      Download a copy of the ERM Applicant User Guide to for instructions on how to add Sub-Forms (e.g. progress reports, final reports) to the study. If you experience difficulty accessing your Ethics or SSA form on ERM and/or creating Sub-Forms, contact the Coordinating Office in the first instance.

      Help and support for use of ERM
      Coordinating Office0408 274 054multisite.ethics@ecodev.vic.gov.au
      Infonetica Help Desk(02) 9037 8404helpdesk@infonetica.net

      Acknowledgement of submission and approval

      • The Office for Research will acknowledge receipt of the report through ERM. The ERM contact person for your study will receive the email response generated.
      • 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.

      Annual and final reporting process

      Reports for all projects are due on the 31st March each year (deadline extended to Friday 22 April 2022)

      • The Office for Research is streamlining the timeframes for submitting annual progress reports by implementing the same annual due date for all projects. Progress reports for all projects are now due on 31 March each year - therefore annual progress reports will no longer be due by the anniversary of HREC approval.
      • This change applies to the reviewing HREC Annual Progress Reports and Site Specific Annual Progress Reports.
      • 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.

      Submit reports via Ethics Review Manager (ERM) only

      • All reports are to be submitted via ERM only. The Office for Research no longer accepts the MS Word copy of the report. Reports submitted on the outdated forms will not be reviewed.

      Frequently asked questions

      Why are we required to submit progress reports each year?

      Submission of annual Progress Reports is a requirement of the NHMRC National Statement on Ethics Conduct in Human Research 2007 (updated 2018) and for CTN/CTA clinical trials, the Therapeutic Goods Act (1989).

      Continued ethical approval of a project is contingent upon the Office for Research receiving your annual progress report and failure to do so may result in withdrawal of ethical approval.

      Why are we implementing one due date for all projects?
      • to streamline the process for researcher teams who will no longer need to remember different reporting dates across different projects
      • improve reconciliation and reporting by the Office for Research
      Do I need to submit an annual report if the anniversary of the HREC approval date is between now and March 2022?

      No. For this year only and to facilitate the change in process, please hold off on submitting the annual report until the due date of 31 March 2022. When the annual report is submitted please ensure that the reporting period is the entire period from the last annual report to March 2022.

      For example, if your last report was submitted on the 1 December 2020, the reporting period for the next report will be 1 December 2020 to 31 March 2022.

      What happens if the annual report is not yet due and the study is closing?

      Please submit the final site report with the annual report by 31 March unless an acknowledgement is required earlier.

      Downloads

      Contact us if you need an accessible version of a download.