Governance - post authorisation submission

What to report

Report any changes or updates to your research project.

These include:

• any project amendments
• any updated insurance certificates or certificate of currency
• a change in your safety reports
• letters from clinical trial sponsors
• your progress reports
• your final report.

You can read the reporting and monitoring factsheet [PDF 203.36 KB] for more information.

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 257.43 KB].

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 stamped by the Research Governance Officer and become the authorisation/acknowledgement document for your records.

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.

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.

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 RGO_Cairns@health.qld.gov.au.

Step 7. If the submission is more than 10 pages, print each document and post to:

CHHHS Research Governance Officer
PO Box 902 (Level 7, William McCormack Place, 5B Sheridan Street)
Cairns QLD 4870