Post-approval submissions

Commencement

A notification of commencement form must be completed and submitted as a post authorisation notification with the SSA via ERM once all approvals are received and the research is ready to commence.

HREC Changes

For research approved by a Metro North HREC, approval is required for any amendments to the protocol, PICFs, advertisements, radio scripts, questionnaires, patient cards, etc.

Governance Changes

HREC Amendments that impact site activities, changes to the protocol or participant information sheet must also be submitted to the research governance office via ERM as a post-authorisation notification.

Annual progress reports

An annual report must be submitted via ERM by 30th of April each year to receive ongoing ethical approval.

Safety reporting

The reporting of adverse events or adverse reactions to the HREC and/or research governance office in clinical trials is an important safety and monitoring requirement.

Final report

A final report with a copy of the final results and any publications must be submitted when the research has finished.