Clinical Research Unit

Phase I: Planning

·         Grant preparation

·         Study hypothesis

·         Study Design

·         Sample Size

·         Study Protocol

·         Feasibility

·         Outcomes

·         Outcome development

·         Costing

•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

Phase II: Study Conduct

Set-up

Conduct

Analysis

Report

Publication

Consent Form

Protocol development

Case report Forms

Database design

Randomization

Ethical approval

Administrative approvals

Logistics

Trial/Study management

Coordination

Randomization

Adverse event management

Monitoring

Trial meetings

Quality assurance

Statistical analysis plan

Data validation

Programming and analysis

Study Reports

Data interpretation

Trial/Study Steering Committee reports

Advice and consulting

drafting aspects of the publication