Anglia Ruskin Clinical Trials Unit services
This page provides further information about the services provided by Anglia Ruskin Clinical Trials Unit (ARCTU).
Local investigator-led trials
At ARCTU, we aim to support investigators through each step of the clinical trial lifecycle. We offer investigators the support to take their study from a basic idea and develop it into a well-designed study. An investigator can be anyone working in a clinical environment (eg doctors, nurses and allied health professionals).
Trial coordination and management
- Protocol design
- Development of supporting documents (eg consent forms, PIS, GP letters etc.)
- Potential funding identification
- Gaining peer review
- Funding applications
- Trial costing
- Budget management
- Preparation for NRES application
- Management of IRAS submission
- CTA submission
- Site identification and feasibility
- Site selection and initiation visits
- Creation and management of trial master files
- Trial oversight and management
- Management of trial amendments
- Trial reporting
- Site close down and archiving
Data management
- Trial randomisation
- Case report form (CRF) design
- Electronic data capture (EDC) database development
- Data entry, validation and management
Statistics
- Trial design
- Sample size calculations
- Statistical plan development
- Reporting to trial committees
- Data analysis, interpretation and reporting
Clinical trialists
- Advice on trial design
- Protocol development
- Chief Investigator support
- Trial committee guidance