The Clinical Research Facility at the Oral Health Research Institute traces its beginnings back more than four decades. The main purpose of the Facility is to provide the infrastructure to conduct high quality clinical research that is in compliance with GCP/ICH regulations and guidelines. This includes assisting our researchers in all aspects of study management and conduct such as:
- Grant negotiation and contract management
- Financial management, and contract review
- Clinical study protocol development
- Clinical study documents preparation
- Institutional Review Board submission and support
- Development of clinic and laboratory logistic plans
- Subject recruitment, screening and enrollment
- Conducting study visits
- Monitoring recruitment, retention, and compliance with the study protocol
- Monitoring data quality and compliance with GCP
- Performing study closeout activities
- Monitoring infection control
- Overall project management
- Providing certified study coordinators and necessary support personnel
- Liaising with Indiana University departments and service centers, including the Office of Clinical Research (OCR), Indiana Clinical and Translational Sciences Institute (CTSI), Department of Biostatistics, University Information Technology Services (UITS), IU Health Pathology and Laboratory Services, Pharmacy, Campus Health Services, etc.