Core Expertise Of The Clinical Research Unit (CRU)
Core Expertise
Phase I: Planning
- Translating research idea into a feasible study hypothesis
- Support for literature review – conduct of systematic reviews and meta-analysis
- Interdepartmental liaison/ collaborations
- Protocol writing and study methodological aspects
- Budgeting
- Statistical analysis plan
- Registration of protocols and preparing documents for funding agencies
Grant preparation
Study hypothesis
Study design
Sample size
Study protocol
Feasibility
Outcomes
Outcome development
Costing
Core Expertise
Phase II: Study Conduct
Set-up
- Consent form
- Protocol development
- Case report forms
- Database design
- Randomization
- Ethical approval
- Administrative approvals
- Logistics
Conduct
- Trial/Study management
- Coordination
- Randomization
- Adverse event management
- Monitoring
- Trial meetings
- Quality assurance
Analysis
- Statistical analysis plan
- Data validation
- Programming and analysis
Report
- Study reports
- Data interpretation
- Trial/Study steering committee reports
Publication
- Advice and consulting
- Drafting aspects of the publication