Reporting to the Research Office is a condition of ongoing ethics approval.
Annual progress reports
- Annual Progress Reports must be submitted by 31 March each year.
- The reporting period is for the 12 months preceding the annual due date of 31 March each year.
- Continued approval of a project is contingent on the Office for Research receiving an annual progress report by the 31 March each year.
Which progress report do I need to complete?
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 or 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 both a:
- Site Progress Report
- Project Progress Report
- Where the RMH HREC is the reviewing HREC but RMH is not a participating site, submit a Project Progress Report
- Where the RMH HREC is not the reviewing HREC but RMH is a participating site, submit a Site Progress Report. Also forward a copy of the completed form to the Coordinating Principal Investigator of the project
For all other studies, complete the Site Progress Report.
Instructions for submitting reports to the Office for Research
Submit reports via Ethics Review Manager (ERM) only
- Complete the relevant report as per below.
- Obtain appropriate signatures through ERM
- Submit the report/s via ERM
Download a copy of the ERM Applicant User Guide for instructions on how to add sub-forms (for example, progress reports and 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.
Contact the Coordinating Office for Clinical Trial Research
General enquiries and ERM application advice
9am to 5pm AET, Monday to Friday
Phone: 0408 274 054
Email: multisite.ethics@ecodev.vic.gov.au
Enquiries and ERM for Research Office administrators
9am to 5pm AET, Monday to Friday
Phone: 0408 410 938
Email: multisite.ethics@ecodev.vic.gov.au
ERM technical support
For ERM technical support, call the Infonetica Helpdesk on (02) 9037 8404 from 9am to 5pm AET, Monday to Friday or email helpdesk@infonetica.net
Acknowledgement of submission and approval
- The Office for Research will acknowledge receiving 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.
Closure of research studies and trials
Regulatory bodies such as the Therapeutic Goods Administration or the Australian Commission for Safety and Quality in Healthcare under the governance framework may still conduct inspections or clinical service accreditation audits at any time respectively.
For the avoidance of doubt, ‘study closure’ should not be interchanged with ‘study completion’ as per the Medicines Australia Clinical Trial Research Agreements. These are separate and distinct regulatory requirements.
The Office for Research understands every study is different. Individual study circumstances can be discussed with the Office for Research at any time. Please email the relevant Office for Research contact office with any queries.
When should my study be closed with the RMH Office for Research?
- In general, the relevant Final Report(s) should be submitted via ERM to the Office for Research within 6 months following the last-patient last-visit at RMH.
For commercially sponsored studies
- Study closure is in accordance with the Sponsors approved procedures.
For collaborative research group and investigator-initiated studies
Project Final Report should be submitted within 6 months of the last patient last visit at the last site conducting follow-up.
A Project Final Report should be submitted within 6 months of last patient last visit at the RMH.
A Site Final Report should be submitted in accordance with the directive of the approving HREC. For the RMH site participation, the Final Report should be submitted within 6 months of the last patient last visit at the RMH.
Frequently asked questions
Submission of Progress Reports is a requirement of the NHMRC National Statement on Ethical Conduct in Human Research 2023.
Continued approval of a project is contingent on the Office for Research receiving your annual progress report.
A single due date for all projects helps to:
- consolidate annual reporting across your active research portfolio.
- Improve reconciliation and reporting by the Office for Research.
In the majority of cases, where a study is closed with the RMH Office for Research, secondary data analysis may still be conducted upon submission of a quality assurance/minimum risk research application. In these cases, secondary data analysis should be closely related to the original research question and study objectives.
Where secondary data analysis is intended to address a new research question, a standard ethics application will generally be required.
What if I’m still analysing data from the approved study protocol?
You can continue to analyse data for the purposes of the approved protocol even after the study or the study site have been closed.
The Office for Research strongly recommends closing studies within 6 months of the last-patient last-visit at the RMH.
When a study is closed:
- no further patient associations can be made to the electronic medical record
- study teams are no longer required to submit post-approval reports
- study teams will not be selected for routine Office for Research monitoring.