Allocated Suite of Services

Study Feasibility & Design

• Statistical aspects of study design
• Sampling strategies
• Randomization

Study Implementation: Administration/Coordination

• Job description templates
• Staff hiring & limited training assistance
• Manual of operations templates
• Serious Adverse Events reporting procedures
• Recruitment, randomization, and retention protocols & training assistance
• GCRC & IRB application assistance

Study Implementation: Data Collection/Management

• Questionnaire/forms development guidance
• Interviewing and data entry protocol assistance
• Variable dictionary (coding)
• Database development
• Data entry procedures
• Quality control procedures
• Data Safety Monitoring Board guidelines

Statistical Analysis

• Assistance with overall analysis strategy
• Analytic file structure
• Alternative choices of statistical models
• Use of statistical programs
• Specialized analyses

Dissemination Guidance

• Preparation of abstracts
• Manuscript submission
• Press releases