All post-approval submissions must be processed via the Ethics Review Manager (ERM). Once submitted in ERM, the HREC office is notified. You do not need to send a separate email copy.

Note: Commencement forms are the only post-approval submission not processed via ERM (see Starting your project for submission steps).

Starting your project

When your study begins, complete the relevant notification of commencement form and email it to FNQ_HREC@health.qld.gov.au.

For Torres and Cape Hospital and Health Service (TCHHS) sites, contact your local research governance officer for commencement notification requirements. Refer to the Torres and Cape Hospital and Health Service's apply for governance authorisation webpage.

Notification of commencement forms

Submission resources

Annual progress reports

To maintain ethics approval, you must submit a progress report by 30 April each year, covering the previous calendar year (1 January – 31 December).

Submission process

  • Log in to ERM and create the project progress report QLD sub-form.
  • Upload the FNQ HREC progress/final report form [DOCX 175.09 KB] signed by the principal investigator.
  • Attach any relevant documents, such as publications, journal articles, or presentations from the reporting period.

Amendments (changes to your project)

Any change to the research protocol, investigator team, or study sites must be reviewed and approved by the HREC and authorised at the approved research site before the changes are implemented. If the principal investigator is unable to continue in their role, you must notify the HREC coordinator in the first instance.

Unsure what to submit?

If you are making other changes to your project and are unclear what documentation is required, contact the HREC coordinator before submitting in ERM.

Documents required

  • Cover letter
    Addressed to the FNQ HREC Chair. Include the HREC reference number, a summary of changes, and a list of all updated documents with version numbers and dates.
  • Tracked and clean copies
    Upload both a version with tracked changes and a clean version of any modified document e.g., protocol, participant information sheet and consent form (PICF).
  • Investigator changes
    Provide a brief (2-3 page) CV for any new research personnel.
  • Adding new research sites
    • Evidence of consultation - a letter or email of support from the relevant department head or organisation representative for all new sites
    • External (non-QH) sites - if the research is being conducted at a non-Queensland Health site, a form of indemnity (HREC review only) is required. For commercially sponsored clinical trials, a current certificate of currency must also be submitted. Refer to the form of indemnity guidance for completion [PDF 248 KB].

Safety reporting and other notifications

All research (including clinical trials)

The principal investigator must promptly notify the FNQ HREC of any matters that may affect the ethical acceptability of the project, including:

  • unforeseen events that may affect participant safety or the continued ethical conduct of the research
  • participant complaints relating to the conduct of the research
  • serious adverse events or safety issues that affect participant safety or materially impact the ethical conduct of the research.

How to report will depend on the nature of the issue.

  • Serious adverse events or safety issues are submitted via the safety report sub-form in ERM.
  • Unforeseen events that require a protocol or document change are submitted as an amendment in ERM (see amendments section).
  • Unforeseen events or participant complaints that do not require a formal submission should contact the HREC Coordinator in the first instance via email FNQ_HREC@health.qld.gov.au or phone 07 4226 5513.

For information on participant complaints, refer to research integrity.

Clinical trials only

Unless otherwise stipulated in your ethics approval or site authorisation letter, the NHMRC safety monitoring and reporting guidance applies to all clinical trials conducted at CHHHS. If your clinical trial was approved by a different HREC, contact that HREC for their safety reporting requirements.

What must be reported to the HREC

  • Urgent safety measures (USMs) instigated by the site or sponsor - an action taken by the investigator or sponsor to eliminate an immediate hazard to participants, within 72 hours of becoming aware of the event.
  • All other significant safety issues (SSIs) - within 15 calendar days of the sponsor instigating or becoming aware of the issue.
  • Annual safety report including a clear summary of the evolving safety profile of the clinical trial. See annual safety reporting for the submission process.
  • Investigator brochure amendments.
  • Data safety monitoring board (DSMB) reports or summaries.
  • Variations to a clinical trial notification (CTN) or clinical trial approval (CTA) submitted to the Therapeutic Goods Administration (TGA).

What does not need to be reported to the HREC

  • Single serious adverse events (SAEs), serious adverse reactions (SARs), or adverse events (AEs) that do not affect participant safety or materially impact the ethical conduct of the clinical trial.
  • Individual suspected unexpected serious adverse reactions (SUSARs) from external sites.
    Note: if the sponsor determines that an external SUSAR materially impacts participant safety or the continued ethical conduct of the trial, it must be reported to the HREC as a significant safety issue (SSI).
  • Six-monthly line listings.

How to submit

Log in to ERM and create the safety report sub-form. Attach all relevant documents.

For USMs, submit to both the reviewing HREC and the relevant RGO. The sponsor is responsible for reviewing safety data across all trial sites. Any emerging safety signals or concerns that may affect participant safety or the conduct of the trial must be reported to the HREC through the annual safety report or as a significant safety issue (SSI).

For full definitions, reporting thresholds, and investigator and sponsor reporting flows for CHHHS sponsored and externally sponsored clinical trials, refer to the research reporting and monitoring factsheet [PDF 203.36 KB].

Annual safety reporting (clinical trials only)

You must submit an annual safety report by 30 April each year, covering the previous calendar year (1 January – 31 December).
Submission process.

  • Log in to ERM and create the annual safety report sub-form.
  • Attach relevant documents, such as the sponsor annual safety report, DSMB reports or summaries, and updated product information or investigator brochures.

Final report

When your project ends, you must notify the HREC by submitting a project final report QLD sub-form in ERM within 30 business days of completion of the study, or on receipt of the final report from the sponsor. The final report should include a copy of the final published results.

Submission process

Governance review (site authorisation)

After the FNQ HREC acknowledges or approves your submission, the following governance review requirements apply.

  • Annual and final reports – non-clinical trial research (CHHHS sites only): no further governance review is required if acknowledged by FNQ HREC.
  • All amendments and safety reports: must be submitted for research governance review at all relevant sites.
  • Clinical trial annual progress, safety, and final reports: must be submitted for research governance review at all relevant sites.
  • Researchers at non-CHHHS sites: confirm governance requirements with your local research governance office.
  • Projects approved by another HREC: If your project received ethics approval from an HREC other than FNQ HREC, you must contact the approving HREC for submission requirements and submit for research governance review.

For further information:

Need help?

For technical support with ERM email ERMhelpdesksupport@health.qld.gov.au.

For questions about FNQ HREC requirements phone 07 4226 5513 or email FNQ_HREC@health.qld.gov.au.

Last updated: May 2026

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