Research and Innovation Services Ethics and Research Integrity Clinical Trials
Clinical Trials
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Global Experience
- International Students
- Open Day
- How to apply
- Pathways to university
- Virtual Open Day
- Living on Campus
- Courses
- Publications
- Scholarships
- Parents and Partners
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Heroes Programs
- Aboriginal and Torres Strait Islander in Marine Science
- Elite Athletes
- Defence
- AI@̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- Current Students
- New students
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Orientation
- Learn̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- Placements
- CEE
- Unicare Centre and Unicampus Kids
- Graduation
- Off-Campus Students
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Job Ready
- Safety and Wellbeing
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Prizes
- Professional Experience Placement
- Employability Edge
- Art of Academic Writing
- Art of Academic Editing
- Careers and Employability
- Student Equity and Wellbeing
- Career Ready Plan
- Careers at ̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- Partners and Community
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û-CSIRO Partnership
- Alumni
- About ̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- Reputation and Experience
- Chancellery
- Governance
- Celebrating 50 Years
- Academy
- Indigenous Engagement
- Education Division
- Graduate Research School
- Research and Teaching
- Research Division
-
Research and Innovation Services
- About Research and Innovation Services
- Partner with us
- Innovate with us
- Research Grants, Tenders and Funding
- Ethics and Research Integrity
- Research Contracts
- Discover our Research and Testing Facilities
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Ideas Lab
- Contact Research and Innovation Services
- FAQs and Fact Sheets
- GECO
- CASE
- College of Business, Law and Governance
- College of Healthcare Sciences
- College of Medicine and Dentistry
- College of Science and Engineering
- CPHMVS
- Anthropological Laboratory for Tropical Audiovisual Research (ALTAR)
- Anton Breinl Research Centre
- Agriculture Technology and Adoption Centre (AgTAC)
- Advanced Analytical Centre
- AMHHEC
- Aquaculture Solutions
- AusAsian Mental Health Research Group
- ARCSTA
- Area 61
- Lions Marine Research Trust
- Australian Tropical Herbarium
- Australian Quantum & Classical Transport Physics Group
- Boating and Diving
- Clinical Psychedelic Research Lab
- Centre for Tropical Biosecurity
- Centre for Tropical Bioinformatics and Molecular Biology
- CITBA
- CMT
- Centre for Disaster Solutions
- CSTFA
- Cyclone Testing Station
- The Centre for Disaster Studies
- Daintree Rainforest Observatory
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Eduquarium
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Turtle Health Research
- Language and Culture Research Centre
- MARF
- Orpheus
- TESS
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Ideas Lab
- TARL
- eResearch
- Indigenous Education and Research Centre
- Estate
- Work Health and Safety
- Staff
- Discover Nature at ̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- Cyber Security Hub
- Association of Australian University Secretaries
- Services and Resources Division
- Environmental Research Complex [ERC]
- Foundation for Australian Literary Studies
- Gender Equity Action and Research
- Give to ̨ÍåÁùºÏ²Ê¿ª½±½á¹û
- Indigenous Legal Needs Project
- Inherent Requirements
- IsoTropics Geochemistry Lab
- IT Services
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Webinars
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Events
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Motorsports
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û Sport
- Library
- Mabo Decision: 30 years on
- Marine Geophysics Laboratory
- Office of the Vice Chancellor and President
- Outstanding Alumni
- Pharmacy Full Scope
- Planning for your future
- Policy
- PAHL
- Queensland Research Centre for Peripheral Vascular Disease
- Rapid Assessment Unit
- RDIM
- Researcher Development Portal
- Roderick Centre for Australian Literature and Creative Writing
- Contextual Science for Tropical Coastal Ecosystems
- State of the Tropics
- Strategic Procurement
- Student profiles
- SWIRLnet
- TREAD
- TropEco for Staff and Students
- TQ Maths Hub
- TUDLab
- VAVS Home
- WHOCC for Vector-borne & NTDs
- Media
- Copyright and Terms of Use
- Australian Institute of Tropical Health & Medicine
- Pay review
A clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedures and devices, a preventive procedure, or a diagnostic device or procedure.
̨ÍåÁùºÏ²Ê¿ª½±½á¹û HREC no longer reviews HREC applications for clinical trials, but these are done by the Townsville Hospital and Health Service HREC. Please visit the for details of how to apply.
If you are planning to conduct a clinical trial, please read the information below and complete and submit a Cover Sheet External Approval HREC Clinical Trials.
To ensure timely approval of all aspects of the clinical trial, it's best to submit your HREC application and governance applications and Site Specific Assessments at the same time so a parallel review of governance and ethics can be carried out.
Clinical Trials must be registered in the publicly accessible database .
Current Clinical Trials: For Clinical Trial Safety Monitoring and Reporting, see the Safety Monitoring tab below.
A clinical trial is defined by the World Health Organisation as:
"Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effect on health outcomes.
Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care etc."
The NHMRC further clarifies the definition by noting that, ‘Interventional research that is not related to the prevention, diagnosis, treatment or management of a health condition should not be categorised as a clinical trial, even if it includes randomisation or has other methodological attributes of a trial.’
Compliance for Clinical Trials has two separate but related components, ethical review by a Human Research Ethics Committee (HREC) and Governance.
Clinical trial researchers and sponsors should undertake the training modules on the Clinical Trials Australia website.
For more information on clinical trials in Australia and access to in the requirements for clinical trials, please refer to the website.
All ̨ÍåÁùºÏ²Ê¿ª½±½á¹û clinical trials require an ethical review by a HREC. Clinical trials involving ̨ÍåÁùºÏ²Ê¿ª½±½á¹û students or staff with participants recruited from Health Service Districts (in a hospital or in the community) need to apply in the first instance to the relevant Health Service District HREC for an ethical approval.
Applications for clinical trials must be submitted using the
Clinical trial ethics applications are no longer being reviewed by the ̨ÍåÁùºÏ²Ê¿ª½±½á¹û HREC. These are now being reviewed by the Townsville Hospital and Health Service HREC. Please consult their for information on submissions to that Committee and refer to the
Please also see the specific submission guidelines for Health Service Districts in on the HREA website.
Governance ensures the appropriate management and supervision of research through systems designed to protect staff, research participants and the organisation whilst ensuring responsibilities are clearly defined.
Clinical Trial Governance is important due to the high level of risk clinical trials pose but also due to the complex interrelated responsibilities which are placed on investigators, sponsors, institutions and HRECs.
Please complete the Cover Sheet External Approval HREC Clinical Trialsand submit it to the Research and Innovation Services Ethics Office so we can start the governance process.
It is important to ensure your data is of high quality, accurate and auditable. A Research Data Management Plan should be completed early on in the project to outline what data will be generated and how it will be managed, stored, kept secure and possibly used in the future. This plan should not be a static document but instead should be amended when required. Please head to the Research Data & Information Management Website for more general information on managing your research data.
Clinical trial data must be retained for a minimum of 15 years.
Clinical trials in Australia must be sponsored by an Australian entity as the local sponsor. The sponsor can be an individual, institution, company or organisation. The responsibilities of the sponsor are to take overall accountability of the clinical trial including the initiation, management, provision of insurance and indemnity and oversees the funding or financing of the trial.
Decide who will be the sponsor of your trial. Clinical trials can be:
- Investigator-sponsored
- Pharma or externally sponsored
- ̨ÍåÁùºÏ²Ê¿ª½±½á¹û can be the sponsor to ̨ÍåÁùºÏ²Ê¿ª½±½á¹û-initiated clinical trials
The sponsor’s tasks can be subcontracted to other parties such as Contract Research Organisations (CROs) but the University will still be responsible for the overall governance and compliance.
Before an application is submitted for ethical review, there must be a trial protocol drafted, and this must be submitted with the HREC application to the HREC.
For a guide on what the protocol must contain, consult the (Standard Protocol Items: Recommendations for Interventional Trials) website and use the .
Clinical trials need to be covered by the appropriate insurance and this is a responsibility of the sponsor or their organisation to organise this.
For ̨ÍåÁùºÏ²Ê¿ª½±½á¹û-sponsored and ̨ÍåÁùºÏ²Ê¿ª½±½á¹û-investigator sponsored trials, contact ̨ÍåÁùºÏ²Ê¿ª½±½á¹û insurance at ̨ÍåÁùºÏ²Ê¿ª½±½á¹û insurance@jcu.edu.au and refer to ̨ÍåÁùºÏ²Ê¿ª½±½á¹û’s Indemnity, Insurance and Legal Claims Policy.
If a clinical trial is pharma-sponsored, insurance cover will usually be through the Pharma-sponsor.
There will need to be a Clinical Trial Agreement in place for each clinical trial site. See for more information on .
Staff working on clinical trials must all have done training in Good Clinical Practice (GCP). A number of training providers offer training and accreditation in GCP.
All clinical trials need to be reviewed for scientific integrity and risk to patients. Queensland Health facilities will have their own scientific review committees and processes for clinical trials that will be accessed through their ethics and governance.
The Australian Code for the Responsible conduct of Research requires all clinical trials to be registered with a recognised register to promote access to information about all clinical trials.
For information on the requirements for Clinical Trial Safety Monitoring and Serious Adverse Event reporting, refer to the resources below: