You will be guided through practical issues like study feasibility assessments, resourcing, budget management and the multi-centred ethics submission process as well as quality systems, audit-readiness and communications to strengthen relationships.
Workshop overview
Do you want to be more confident when starting up your next research project or when dealing with quality and GCP issues at your research site? Would you like to develop skills to coordinate more complex projects? This workshop will explore tools, strategies and best practice for a range of processes essential to the effective starting up and running of single and multi-centre research sites.
You will be guided through practical issues like study feasibility assessments, resourcing, budget management and the multi-centred ethics submission process as well as quality systems, audit-readiness and communications to strengthen relationships.
This workshop seeks to build on the topics covered during the first workshop titled ’Conducting Clinical Research – Essential GCP training for New Coordinators and Researchers’ by helping attendees apply what they have learnt and broaden their understanding of effective investigational site management. To ensure a quality program, ARCS has developed this workshop in consultation with an Australian advisory board. Collectively, the individuals on the board have over 100 years’ experience in managing investigational sites.
Who should attend?
This two-day workshop is intended for experienced study site staff; including investigators, and study coordinators. There is a basic assumed knowledge of terminology and processes as outlined in ’Conducting Clinical Research – Essential GCP training for New Coordinators and Researchers.’ This workshop is for study site staff from hospital as well as academic research. Attendees will value the opportunity to discuss and share experiences regarding successful site management and practical application and problem solving of ethical issues in clinical research.
Workshop highlights
- Assess the feasibility of a study at your site
- Plan study resources and responsibilities for a study; including staff, equipment and facilities
- Devise, negotiate and manage a study budget
- Discuss the roles and responsibilities of the lead and local site in multi-centre research
- Research standards overview
- Having the right quality systems, such as SOPs, in place for your study site
- Maintain your site as ’inspection/audit ready’
- Managing GCP issues more effectively
- What is effective communication?
- Identify your areas of influence to better manage your Site - CRO/Sponsor Relationships
