Governance - post authorisation submission

What to report

Report any changes or updates to your research project.

These include:

• any project amendments, including amendments to study documents
• any updated insurance certificates or certificate of currency
• safety reports
• letters from clinical trial sponsors
• contract amendments
• amendments to the Public Health Act (PHA) application and approval letter
• updated Clinical Trial Notification (for clinical trials only)
• your progress reports
• your final report
• publication or presentations.

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 post authorisation notification (PAN) submission advice document [PDF 303.82 KB].

Step 1. Prepare a cover letter (reports) [DOCX 35.68 KB] or cover letter (amendments) [DOCX 37.47 KB] with a brief description of your request and list the documents you’re going to submit (including version numbers and dates).

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 and the Post Authorisation Notification to RGO_CHHHS@health.qld.gov.au.