Vanderbilt Coordinating Center

Goal

The goal of the Vanderbilt Coordinating Center “Local Site” is to assist both new and experienced investigators with the reviewing, preparation, and conduction of Clinical Trials. Experienced, certified clinical research coordinators are available, both on and off site, to provide complete study coordination on a range of services, including: study feasibility, logistical considerations, IRB preparation and submission, study start-up, regulatory compliance, participant recruitment, data management, budgetary review and negotiation as well as financial management.

Overview

The Vanderbilt Coordinating Center is staffed by qualified, experienced, and certified clinical research coordinators who are well versed in the application of Good Clinical Practice (GCP) to their day to day activities. These multi-disciplinary, registered nurse and non-nurse coordinators, known collectively as the Study Coordinators, provide both on and off-site services to investigators. Through their unique outreach model, they are able to offer study coordination at multiple sites for multiple investigators simultaneously. While they are able to provide complete study coordination to an investigator, they can also be called upon to provide any one of a range of services including, but not limited to:

• Site selection and feasibility assessment
• Budget development and negotiation, facilitate contract negotiations and execution, financial billing compliance approval, financial tracking and management
• Logistical considerations and planning, study start up and staff training
• IRB Preparation and submission, IRB amendments, adverse events, annual reviews
• Regulatory document compilation and maintenance (FDA approval of INDs and IDEs, Medicare billing approval)
• Design of electronic Source documents and Case report forms
• Patient Recruitment, Screening, Consenting and Follow Up
• Drug administration, dispensing and accountability
• Phlebotomy and specimen processing and storage
• Data management services (data collection, data entry, internal QA/QI audit program)
• Study close out and archive

Facilities

The Vanderbilt Coordinating Center offers space dedicated to research, providing an ideal environment to conduct studies safely and efficiently according to Good Clinical Practices (GCP). Our facilities include:

• Main Campus at Village at Vanderbilt
• 5 exam rooms
• Conference room for study training
• On site monitoring visit space with computer access and printing capabilities
• Processing lab with a specimen refrigerator, -70 degree freezer and a -20 degree freezer, as well as a refrigerated centrifuge, dry ice.  UPS and FedEx daily pick up for specimen shipping.
• Medication and device storage (refrigerated and room temp)