Conducting multi-centre international research Leanne M Aitken Princess Alexandra Hospital & Research Centre for Clinical and Community Practice Innovation, Griffith University

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 2 Elements to establish Flexible but well designed project structure Multi-dimensional communication methods Strategies to optimise intervention fidelity Centralised data management Ethical considerations Budget considerations

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 3 Flexible Well Designed Project Structure Consider staff required – PIs, PDs, RAs Consider who will coordinate operational activity at each site – experienced Project Directors Outline how all the positions interact Outline the relationship between each of the sites Consider both research sites & recruitment sites

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 4 Multi-dimensional Communication Methods Commence in planning stages Involve all personnel, but may need separate forums, e.g. PIs, PDs, etc Different formats: –Written – s, regular reports, minutes, protocols –Verbal – teleconference, face-to-face meetings Ensure feedback of progress: –Enrolment against target –Completeness of data

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 5 Optimise Intervention Fidelity Training of all relevant personnel Limit number of personnel delivering intervention Specific protocols to outline process, environment etc Funding for central training or for central project staff member to travel to all sites

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 6 Centralised Data Management Facilitates strong quality assurance project – series of local and central data checks Consider methods to transfer data – compatibility, security, timeliness Ensures data is available short time period after study completion

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 7 Ethical Considerations Protocol needs to accommodate varying ethical requirements May need to adhere to another countries ethical requirements – particularly if funding coming from another country Allow extra time to negotiate all processes

Research Centre for Clinical and Community Practice Innovation & Princess Alexandra Hospital 8 Budget Considerations Expect budget variability Consider which currency is incorporated into contracts