Clinical Trials

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.

James Cook University HREC no longer reviews HREC applications for clinical trials, but these are done by the Townsville Hospital and Health Service HREC. Please visit the THHS HREC website 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 Australian New Zealand Clinical Trials Registry.

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 training modules in the requirements for clinical trials, please refer to the Clinical Trials Australia website.

All JCU clinical trials require an ethical review by a HREC. Clinical trials involving JCU 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 Human Research Ethics Application Form

Clinical trial ethics applications are no longer being reviewed by the JCU HREC. These are now being reviewed by the Townsville Hospital and Health Service HREC. Please consult their website for information on submissions to that Committee and refer to the committee's submission checklist.

Please also see the specific submission guidelines for Health Service Districts in New South Wales and Queensland 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
  • JCU can be the sponsor to JCU-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 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) website and use the SPIRIT checklist.

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 JCU-sponsored and JCU-investigator sponsored trials, contact JCU insurance at JCU and refer to JCU’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 Medicines Australia for more information on CTRAs and CTRA templates.

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: