YCCI has partnered with the Yale Cancer Center to create a quality assurance and safety monitoring system to support investigators and improve the quality of clinical research at Yale. The Office of QA and Training supports QA activities; study monitoring; training; and review committee administrative support.
The QA office is a resource that assists investigators at the School of Medicine, including Yale Cancer Center, in conducting high-quality compliant clinical research. In addition to consulting with investigators on quality-related issues upon request and reviewing trials based on a risk-based stratification, staff members are available to:
- Conduct internal audits
- Identify areas for education or system improvements
- Consult with investigators who have been notified that they will undergo an external audit to correct any deficiencies
- Review external audits and monitoring reports
- Consult with investigators and research staff regarding compliance with Good Clinical Practices
- Provide training and educational instruction to augment the education provided institutionally
The QA office provides expertise for centralized monitoring of investigator-initiated multicenter studies for which Yale is the lead site. Staff members are available to develop Data and Safety Monitoring Plans; set up and help conduct Data and Safety Monitoring Boards (DSMB), provide on-site or remote monitoring services, or assist with screening, interviewing, and hiring contract monitors.
TrainingThe YCCI Clinical Research Training Program provides training opportunities for faculty and research staff to ensure that research is carried out appropriately and efficiently. Our educational offerings include professional development for faculty, research nurses, coordinators, data managers, and regulatory, administrative and financial staff involved in clinical research. For more information, visit Clinical Research Training.
Review Committee Administrative Support
The QA Office provides administrative support to four review committees:
- The Protocol Review Committee & Protocol Life Cycle Subcommittee (Yale Cancer Center)
- The Data and Safety Monitoring Committee (Yale Cancer Center)
- The Science and Safety Committee (YCCI)
- The Pediatric Protocol Review Committee (YCCI)
Quality Assurance Contact:
Director of Quality Assurance 2 Church Street South, Suite 112
Director of Training 2 Church Street South, Suite 112