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Frequently Asked Questions

Dr Hughes and Assoc. Prof. Jones are available for face-to-face consultations or via telephone, Teams, or Zoom. Learn more.
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.
Clinical trials aimed at developing new interventions are conducted in four phases to study treatment safety and efficacy. Read more.
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.
Learn more about how to participate in a clinical trial here.
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.
Visit the research feedback and complaints page if you have any concerns about how clinical trial coordinators are conducting their clinical trials.
Email or call (07) 5687 0237 who will refer you to the most suitable team within the Health Service.
Yes, the Clinical Trial Unit is part of the Office of Research Governance and Development at Gold Coast Health. Read more.
Our Health Service offers Good Clinical Practice (GCP) compliant facilities and resources expected from Clinical Trial sites. Read more.
The Research Policy at Gold Coast Health endorses the current use of the National Clinical Trial Standard Operating Procedures. Read more.
The Clinical Trial Manager can advise the current timelines for study start up activity, but this guide provides an estimation. 
The closing dates for HREC applications and HREC meeting dates can be found here.
The Human Research Ethics Committee (HREC) works on a 60-day clock to approve research. Read more.
Ethics approval is granted for an initial three-year period, with continuation dependant on the submission of an annual report.
When preparing a research application, keep these tips in mind.
Review this checklist for information on documents required for your application
We use the ERM to facilitate and support all reports, amendments, or notifications. Read more.
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 visit.

Any changes to your research project that occur after initial ethical approval has been obtained must also be ethically approved. These should be submitted on the 'QLD Amendment Form' which is a Sub Form under the HREA in ERM. Please contact your Research Ethics Officer if you are unsure what documents are required for your amendment. 

Amendments must also be authorised by the participating sites’ Research Governance Office. Once ethical approval for an amendment has been obtained, the amendment should also be submitted to the Research Governance Office via ERM as a ‘Post Authorisation Notification Form’'. Read more.

GCHHS Ethics and Governance Officers will guide you simultaneously through both processes, to facilitate a streamlined review of your application. Read more.
These roles perform monitoring of behalf of the Gold Coast Hospital and Health Service when clinical trials are sponsored. Read more.
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.
Monitoring is designed to detect, correct and prevent potential or existing problems. Read more.
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.
Any replacement Lead PI must meet or exceed the same criteria by which the original Lead PI was appointed. Read more.
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. 
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.
Yes, the letter of support signed for a grant application can be used for HREC/Governance applications. 
When budgeting for staffing costs for your research project, approximately 30% should be added as oncosts for project staff FTE. Read more.
All links and templates for supporting documents relevant to the GCHHS grant you are applying for can be found within Smartygrants.
Our library services are located onsite at Gold Coast University and Robina Hospitals. Learn more.
We welcome feedback to continuously improve on our research-related processes. Please use the form on the left to initiate your contact with us.
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.
A donation to Gold Coast Hospital Foundation is one of the most meaningful ways to make a bigger impact in your community. Learn more. 
We welcome feedback to continuously improve. Please use the form on the left to initiate your contact with us.
Health research is a series of steps to collect and analyse information to better understand a health topic or medical condition. Read more.
Health consumers have unique experiences and understandings of a medical issue or of a health service. Read more.
There are lots of ways consumer partners can help improve research at Gold Coast Health. Read more.
You do not need research experience to be a consumer partner. Read more. 
There are lots of benefits to being a consumer partner. Read more.
We recommend using this contact support centre to get in touch. Gold Coast Health also has a Consumer Advisory Group and an Always Care Consumer Network that researchers and consumers may wish to engage with.  
A donation to Gold Coast Hospital Foundation is one of the most meaningful ways to make a bigger impact in your community. Find out how you can donate now. 
We value your feedback. You can submit a complaint, give a compliment, or offer a suggestion in the box below to help us improve our service.

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