Study Design

• Select appropriate study design and measurements
• Use data from large community-based studies for study planning
• Develop protocols
• Design, pretest, and validate instruments

Due to our academic status and the prominence of our faculty, we have excellent working relationships with the FDA and NIH, which can facilitate creation and approval of study protocols.

Clinical Site Selection and Management

• Select appropriate clinical centers nationwide
• Design recruitment and follow-up procedures
• Select and contract with core labs and reading centers
• Deliver site training and staff certification in study procedures, conduct of interviews, measurements, data management, and GCP
• Direct clinical measure quality control

To meet the needs of our studies, the Coordinating Center has associations with a large number of clinical sites, both nationally and internationally, that have a history of successful recruitment and protocol compliance.

Study Coordination and Implementation

• Develop systems and guidelines for study governance
• Establish and maintain communications systems
• Monitor study-wide progress
• Coordinate study-specific committees
• Provide or subcontract core technical services (e.g., central laboratories and reading centers)
• Coordinate shipment of specimens
• Maintain comprehensive study-wide archive
• Organize and coordinate data and safety monitoring board activities
• Coordinate publications involving multiple investigators
• Design and oversee implementation of reporting and tracking systems

Each study is managed by a project director who has responsibility for being the liaison to government agencies, clinical sites, and vendors, as well as overseeing the study schedule and budget. Our project directors collectively have over 40 years of study management experience.