Post-approval reporting2017-12-08T03:35:07+00:00

Post-approval reporting

While undertaking a research project, researchers have an obligation to both the participants and to the Human Research Ethics Committee (HREC) and Research Governance Officers to provide reporting and monitoring.

Reporting timeframes

Commencement, annual and final reporting

The commencement form should be sent as soon as the study commences. Use the start date rather than the date the first participant is successfully recruited.

The ‘annual progress/final report’ form is due every twelve months on the anniversary of the HREC approval of the study and when the study is complete. A copy of the final results and any publications should be sent as soon as they are available.

Reporting adverse events

Reporting a local Serious Adverse Event is required as soon as an event is reported.

Amendments

Your sponsor should direct the periodical schedule of sending the safety and SUSAR reports, e.g. 6 monthly SAE /safety/ SUSAR reporting to the relevant HREC.

Remember that HREC approval is required for any amendments to the protocol, PICF s, advertisements, radio scripts, questionnaires, patient cards, etc.

Please refer to the single and multi-centre amendment checklist and forward one set of papers with a covering letter from the Principal Investigator explaining the amendment rationale and whether/how it will affect the study.  Please also provide an electronic copy of all documentation.

Ensure that all documents submitted for approval contain document identifiers, version numbers, dates and page numbers.

Amended documents also need to have the changes highlighted (use the Microsoft Word Track Changes feature for this).

Single and multi-centre amendments

Data archiving, retention and disposal

Contact us

The Prince Charles Hospital

Research office
Building 14
Rode Road
CHERMSIDE QLD 4032

Human Research and Ethics Committee
Phone: (07) 3139 4500
Open: Monday-Friday, 8.00am-3.00pm
Email: ResearchTPCH@health.qld.gov.au
Chairperson: Dr Russell Denman
Coordinator and Manager: Anne Carle

Research Governance Officer
Phone: (07) 3139 4407
Open: Monday-Friday, 8.00am-3.00pm
Email: RGOTPCH@health.qld.gov.au
Contact:  Ascar Yu

Royal Brisbane and Women’s Hospital

Human Research Ethics Office
Level 7, Block 7
Butterfield Street
HERSTON QLD 4029
Phone: (07) 3646 6132
Open: Monday-Friday, 7.30am-4.00pm
Email: RBWH-Ethics@health.qld.gov.au
Acting Chairperson: Dr Allison Sutherland
Coordinator: Ann-Maree Gordon

Research Services
Lower ground floor, Executive Offices
James Mayne Building
HERSTON QLD 4029
Phone: (07) 3646 8579
Fax: (07) 3646 2355
Open:  Monday-Friday, 7.45am-3.45pm
Email: RBWH-RGO@health.qld.gov.au
Contact: Jacqueline Robinson

Redcliffe, Caboolture and Kilcoy Hospitals and Community, Indigenous and Subacute Services

Research Office
Redcliffe Hospital
Anzac Avenue
REDCLIFFE QLD 4020

Research Governance Officer
Phone: (07) 3883 7243
Open: Monday-Friday, 8.00am-4.30pm
Email: RCRGO@health.qld.gov.au
Contact: Vanessa Constable

Back to top