On this page

    Understanding research and clinical trials

    Health and medical research can take many forms including observational studies, data-driven studies and clinical trials.

    Clinical trials are research studies involving people. They are used to evaluate the safety, effectiveness and performance of interventions such as medicines, medical devices, procedures and models of care.

    Other types of health and medical research may involve observing health outcomes, analysing existing data, laboratory-based research, or evaluating health services and models of care.

    Research life cycle

    Research involving people follows a series of defined stages, from developing an idea through to analysing findings and disseminating results.

    While the process may vary depending on the type and complexity of the project, the key stages are generally the same.

    Research life cycle stages 

    • Identify the question your research aims to address.  
    • Review existing literature to inform and refine your research question. 
    • Assess feasibility, resources and risks.
    • Develop your study design and research methodology. 
    • Define your patient population, interventions, outcomes and data collection methods, as appropriate.  
    • Document your research procedures, governance arrangements and risk management approach. 

    Learn more about clinical trial types, phases and requriements:
    Australian clinical trial handbook

    Research ethics

    Research ethics considers whether a research project is ethically acceptable and protects the rights, safety and wellbeing of participants. 

    1. Determine the ethics requirements for your research project:
    1. Prepare and submit your ethics application through the Ethical Review Manager (ERM).  
    1. Submit your application to an appropriate Human Research Ethics Committee (HREC) for review of ethical acceptability, participant safety and compliance with national standards

    Refer to the National Statement on Ethical Conduct in Human Research 2025 

    Multi-centre research 

    Multi-centre research involves conducting a study across more than one site or organisation. 

    To find out how to submit a single ethics submission for multi-site research projects, visit the National Mutual Acceptance page.

    To find out about research ethics and governance requirements in Victoria, see Research ethics and governance in Victoria.

    Research governance

    Research governance considers whether an organisation can support and authorise a research project, including the resources, processes and oversight needed to conduct it safely and effectively. 

    • Confirm that appropriate staff, facilities and resources are available to support the research project.  
    • Obtain governance authorisation before commencing research activities at a site. 

    Local research governance requirements 

    Research governance processes vary between health services. 

    Some institutions use the Ethical Review Manager (ERM) system to manage Site Specific Assessment (SSA) applications and approvals. Refer to your institution's local requirements.

    Before commencing your research project, ensure all required approvals and regulatory requirements are in place. 

    • Meet sponsor requirements
    • Confirm that all ethics, governance and regulatory approvals have been obtained before commencing research activities. 
    • Recruit participants and commence study activities in accordance with approved protocols.  
    • Collect and manage data throughout the study.  
    • Ensure research activities are conducted in line with ethics, governance and regulatory requirements. 
    • Comply with approved protocols. 
    • Maintain participant safety and informed consent. 
    • Report amendments, serious adverse events and progress. 
    • Ensure documentation is complete.
    • Analyse and interpret data collected.  
    • Identify key findings and assess their significance.  
    • Consider the implications of the findings for practice, policy and future research.
    • Share your findings with relevant audiences, including participants, researchers, clinicians, and healthcare organisations.  
    • Publish or present results to contribute to knowledge and evidence-based practice. 
    • Support the translation of research findings into policy, practice and future research.

    Contact us

    For questions about research and clinical trials, please email research@safercare.vic.gov.au.

    Was this content helpful to you?
    Print this page
    [ Back to top ]