The IMPACCT Trials Coordination Centre (ITCC) supports researchers to undertake high-quality clinical studies and/or clinical trial support for drugs, non-pharmacological interventions and medical devices.
The ITCC offers expertise in moving a new drug, intervention, device or health service(s) reform intervention trial from concept to start up, conduct, completion, and dissemination/translation without the research team having to maintain a specialist trial team.
ITCC provides a range of trial-related services including:
- new study design and development (protocol development; systematic and literature reviews; sample size calculations
- multi-site clinical trial coordination (site feasibility and confirmation; trial registration; human research ethics applications; patient information and consent form development; clinical trial research agreements; HREC Review and Indemnity; clinical trial insurance; clinical trial notifications to the TGA; Standard Operating Procedures (SOPs), guidance documents, templates; Coordinating Principal Investigator and Principal Investigator manuals
- data management (case report form build in readiness for direct data entry (REDCap); development of data collection worksheets; assessment tool licencing; randomisation; database access and helpdesk; data checking plan/manual; data checking; monitoring plan/manual; monitoring; statistical analysis plan; statistical analysis; health economic analysis)
- safety reporting (adverse event reporting; medical monitors; Data and Safety Monitoring Committee secretariat)
- site investigator manual development
- pharmacy manual development (randomisation schedules; online randomisation and unblinding; pharmacy monitoring)
- investigational medical product (GMP-certified manufacture (outsourced); stock ordering)
- project management (study budgeting; study payments and tracking)
- site research staff training (site initiation; consent training; GCP training), and
- recruitment assistance (promotional materials including posters, postcards, information brochures; consent scripting)