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Clinical trial governance

UQ Clinical Trial Governance Guide

The UQ Clinical Trial Governance Guide provides a high-level overview to support researchers in the planning, conduct and close-out of clinical trials at UQ. It outlines key governance activities across the trial lifecycle, supporting interpretation and application of University policies and procedure in a clinical trial context. Core concepts are defined, key requirements are summarised, and direction is provided to relevant tools, guidance and expert support.

The guide draws on the Health Translation Queensland (HTQ) Clinical Trial Planner, alongside other relevant sources, and incorporates UQ-specific governance considerations and advice. Where relevant, links to the HTQ Clinical Trial Planner are included to enable access to supplementary materials and supporting resources.

Positioned between overarching policy and detailed procedural documents, it supports consistent understanding and application of governance requirements. Links are provided to authoritative University and external sources to ensure access to current and applicable information.
Recognising the diversity of clinical trial and study types, the guidance is intended to be applied proportionately. Individual trials may vary in scope, complexity and regulatory requirements, and may not require all elements outlined.

As an evolving resource, additional materials, including templates, FAQs and further guidance, will be developed and incorporated over time. See also the UQ Clinical Trial Governance Procedure

Initiate

Steps 1–3: Define trial scope, secure funding and sponsorship, outline governance.

Prepare

Steps 4–7: Define procedures, set up systems and prepare sites and staff.

Conduct

Steps 8–11: Recruit participants, collect data, monitoring and compliance.

Close

Steps 12–14: Analyse data, report findings, archive and close out.

We welcome your feedback

The UQ clinical trial framework is currently in a development phase. We invite feedback from researchers and clinical trial support teams on the content, advice and usability of the framework to support continuous improvement and alignment with practice at UQ.

Please send your feedback to pvcr.admin@uq.edu.au.