Reporting obligations
You must provide annual progress and final reports to the Torres and Cape Research Governance Officer by emailing Torres-Cape-Research-Governance@health.qld.gov.au.
Please review the FNQ Human Research Ethics Committee (FNQ HREC) Post Approval Submission Requirements or the website of the ethics committees that provided your approval for their requirements. They will include ethics requirements for amendments, progress/final reports, study updates, change of investigators and/or extension of HREC approval.
Your research authorisation approval letter will include conditions of authorisation that you need to comply with while your study is running. This includes your reporting requirements.
If you don't comply with reporting requirements, the chief executive may withdraw your authorisation.
Researchers are responsible for managing their costs and resources, as negotiated and agreed upon in their budget. You must provide financial reports as part of financial outcomes.
The research governance officer may conduct monitoring audits on authorised research.
What to report
Report any changes or updates to your research study.
These include:
- any study amendments
- your progress reports
- your final report
- any updated insurance certificates or certificate of currency
- a change in your safety reports
- letters from sponsors
How to report
You'll need to submit your reports online by creating a sub-form in the Ethics Review Manager (ERM).
Follow the quick guide to creating a sub-form [PDF 300 KB] on the Cairns and Hinterland HHS website
Step 1. Prepare a cover letter with a brief description of your request and list the documents you’re going to submit (including version numbers and dates). The cover letter will be acknowledged by the research governance officer.
Step 2. Log in to the ERM and click on the relevant site-specific assessment (SSA) for your research project.
Step 3. Create a sub-form in the ERM and select Post Authorisation Notification Form – RGO. You’ll need to create a separate sub-form for each notification.
For example, complete a separate sub-form for a project amendment and a progress report.
Step 4. Complete the sub-form and upload the following documents:
- cover letter detailing what you are advising and listing the documents being provided
- HREC approval or acknowledgement
- relevant project documents such as a progress report, study protocol document, certificates and letters
- patient information and consent forms - this may include site-specific forms.
For study amendments, we'll need 2 versions for each of the changed documents. One document with tracked changes and one without tracked changes.
Step 5. Click Submit in the Actions panel to submit the sub-form.
Step 6. Email a PDF copy of the cover letter, the Post Authorisation Notification Form and each document you submitted to Torres-Cape-Research-Governance@health.qld.gov.au.
Step 7. If the submission is more than 10 pages, print each document and post to:
Research and Governance Officer
Torres and Cape HHS
PO Box 5607
Cairns Qld 4870