Study Coordination Unit
PATIENT/HEALTHY VOLUNTEER STUDY MANAGEMENT
- Identification and recruitment of study subjects based on well-defined criteria developed for each study.
- Development of paper and electronic case report forms for data collection.
- Creation of databases for projects that do not require Outcomes & Epidemiology Unit expertise.
- Study subject management on protocols, including data collection and entry into study-specific databases.
- Monitoring and reporting adverse events.
- Coordinating nursing, clerical, laboratory, and data management activities for successful project completion.
IRB & REGULATORY ISSUES
- Preparing and submitting all necessary documentation to the Vanderbilt and/or Meharry IRB for approval.
- Handling IRB and other regulatory requirements of study performance, including annual continuing reviews.
- Maintaining all regulatory documents in study-specific Regulatory Binders.
- Meeting with study monitors as appropriate to review study performance.
Please contact the CDC CORE LEADERSHIP to discuss the above services or other services that you might need. We are eager to hear your ideas about additional core services not listed here that can help your research.