For trial investigators

Proposing, setting up, and delivering orthopaedic clinical trials through CTAU

Investigator-led trials

Studies proposed and led by investigators – CTAU assesses feasibility and coordinates approved study delivery.

CTAU supports investigator-led trials funded through MRFF, NHMRC, and philanthropic sources. These are surgeon- and investigator-led research questions, often including large pragmatic and registry-enabled trials that leverage the AOANJRR platform.

 

What CTAU provides

  • Feasibility assessment – clinical question evaluation, study design review, site capacity, data availability, and budget development
  • Study setup – protocol development support, ethics and governance approvals, contract and indemnity coordination, site and system activation
  • Study delivery – coordination across sites, recruitment support, quality monitoring, and regulatory reporting
  • Output coordination – commissioning CDMS for data management and statistics, publication support, and contract deliverable management.

The project pathway

CTAU follows a structured five-step governance pathway for all investigator-initiated studies:

1
Early Contact
Preferably ≥12 weeks before a major grant deadline.
2
Feasibility
Clinical question, design, sites, data, budget and capacity.
3
Decision
Prioritise, approve, defer or decline.
4
Delivery
Named clinical liaison and accountable operational lead.
5
Oversight
Monitor progress, safety, quality, budget and outputs.

When to Contact CTAU

Investigators should make early contact, ideally at least 12 weeks before a major grant deadline. This allows sufficient time for feasibility assessment, budget development and study design input before submission.

Industry studies

For industry-initiated or -funded clinical studies, CTAU manages setup, contracts, and study operations. All industry studies must meet:

  • independent protocol requirements
  • independent contracting and publication requirements
  • requirements relating to commercial funding and scientific oversight
  • appropriate governance and conflict-management requirements.

Registry-nested studies

CTAU coordinates studies that leverage the AOANJRR (Australian Orthopaedic Association National Joint Replacement Registry) platform. Registry-nested studies use the existing data infrastructure to enable efficient, large-scale clinical research – including cluster-randomised and hospital-randomised crossover trial designs.

Important: Separate accountability

CTAU enables research delivery but does not replace the organisations and investigators that retain formal responsibility. Investigators remain responsible for grant funding, study sponsorship, research themes, recruitment, and their own data management and statistical analysis (delivered by CDMS).

Funding sources for investigator-led studies

NHMRC MRFFC Philanthropic grants External grants 4th year Federal Gov grant

Ready to propose a study?

Contact CTAU early in your planning process. The earlier we're involved, the better we can support feasibility, design, and delivery.


Contact CTAU