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Frequently Asked Questions
How do I contact the Biostatistics Service?
Dr Hughes and Assoc. Prof. Jones are available for face-to-face consultations or via telephone, Teams, or Zoom. Learn more.
What is a clinical trial?
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Read more.
What are the phases of clinical trials?
Clinical trials aimed at developing new interventions are conducted in four phases to study treatment safety and efficacy. Read more.
Who can be part of a clinical trial?
People of all ages, from children to the elderly, and with all types and stages of a disease or condition can take part in a clinical trial. Read more.
How can I participate in a clinical trial?
Learn more about how to participate in a clinical trial here
What if I no longer wish to participate?
If you no longer wish to participate in a clinical trial you can stop taking part at any time without giving a reason and without it affecting the care that you receive. Read more.
What if I have a query or complaint about a clinical trial?
What is the single point of contact for Clinical Trials at Gold Coast Health?
Does Gold Coast Health have a dedicated centralised Clinical Trial Unit?
Yes, the Clinical Trial Unit is part of the Office of Research Governance and Development at Gold Coast Health. Read more.
What services and facilities are available to support the facilitation of Clinical Trials at Gold Coast Health?
Our Health Service offers Good Clinical Practice (GCP) compliant facilities and resources expected from Clinical Trial sites. Read more.
Does the Clinical Trial Unit use Standard Operating Procedures to share with Sponsors?
The Research Policy at Gold Coast Health endorses the current use of the National Clinical Trial Standard Operating Procedures. Read more.
What is the Study Start Up processes in the Clinical Trial Unit?
The Clinical Trial Manager can advise the current timelines for study start up activity, but this guide
provides an estimation.
What are the Human Research Ethics Committee (HREC) application closing dates and HREC meeting dates?
The closing dates for HREC applications and HREC meeting dates can be found here
How long will it take to receive ethics approval?
The Human Research Ethics Committee (HREC) works on a 60-day clock to approve research. Read more
How long does ethics approval last?
Ethics approval is granted for an initial three-year period, with continuation dependant on the submission of an annual report.
Are there any tips for researchers submitting applications?
Which supporting documents are recommended for HREC applications?
Review this checklist
for information on documents required for your application
Do I need to upload documents onto Ethical Review Manager (ERM)?
We use the ERM to facilitate and support all reports, amendments, or notifications. Read more.
Do I need to submit an annual report?
Yes, you will be required to submit a report for each research project. Annual reports are due on the 30th April each year. Based on information in the progress report, the HREC or Research Governance Office may decide to undertake a monitoring
How do I amend my research project after submission and/or approval?
What’s the difference between ethics and governance?
GCHHS Ethics and Governance Officers will guide you simultaneously through both processes, to facilitate a streamlined review of your application. Read more.
What is the role of GCHHS Research Monitors?
These roles perform monitoring of behalf of the Gold Coast Hospital and Health Service when clinical trials are sponsored. Read more
What is Monitoring?
Monitoring is designed to ensure the safety and well-being of human participants and it is critical to the conduct of high-quality studies. Read more.
Why is monitoring performed?
Monitoring is designed to detect, correct and prevent potential or existing problems. Read more.
Where is monitoring performed?
During a monitoring visit, a research come and visit the research team in their clinical area and spend around half a day reviewing the research project documents and the data. Read more.
What if I am the lead PI of a successful grant and then leave GCH and or the project, before the project is complete?
Any replacement Lead PI must meet or exceed the same criteria by which the original Lead PI was appointed. Read more.
Who should sign a letter of support?
A letter of support should be signed by the line manager of the lead PI and the lead in the areas where most of the research will be performed, e.g., Head of Department or Clinical Director.
Do I need to have a collaborator letter signed for each collaborating team member?
The collaborator letter is only needed when a project will make significant use of resources and space at an institution outside of GCH and signed by the relevant leadership in that institution who has authority for the use of resource/space.
Can I use the same letter of support for a grant application and HREC/Governance applications?
Yes, the letter of support signed for a grant application can be used for HREC/Governance applications.
What oncosts I should consider when budgeting staffing costs for my research project?
When budgeting for staffing costs for your research project, approximately 30% should be added as oncosts for project staff FTE. Read more.
What supporting documents do I need to submit with my grant application?
All links and templates for supporting documents relevant to the GCHHS grant you are applying for can be found within Smartygrants
How can I contact the library staff?
Our library services are located onsite at Gold Coast University and Robina Hospitals. Learn more.
What if I have applied or been accepted for an external grant?
How do I give feedback about your research, ethics and governance processes?
We welcome feedback to continuously improve on our research-related processes. Please use the form on the left to initiate your contact with us.
How do I complain about the conduct of a study?
Please use the form on the left to initiate your contact with us. Any complaint will be investigated promptly and you will be informed of the outcome.
How can I help fund health research?
A donation to Gold Coast Hospital Foundation is one of the most meaningful ways to make a bigger impact in your community. Learn more.
How do I give feedback or seek further information?
We welcome feedback to continuously improve. Please use the form on the left to initiate your contact with us.
If our FAQs on this page don't answer your question or if your query relates to a complaint, please enter it in the box below. Include any details you think would help us to answer you as quickly and accurately as possible.