Office of Quality Assurance and Training
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. QA Specialists are available to consult with investigators on quality-related issues, such as Federal Regulations, Good Clinical Practice or other protocol compliance issues, upon request. In addition, QA Specialists review trials using risk-based stratification, providing feedback on compliance and opportunities for systems improvements.
For more information visit the QA page here.
The QA office provides expertise for centralized monitoring of investigator-initiated clinical trials, including multicenter trials for which Yale is the lead site. Staff members are available to develop Data and Safety Monitoring Plans; set up and help conduct protocol-specific Data and Safety Monitoring Boards (DSMB), provide on-site or remote monitoring services, and assist with the screening, interviewing, and hiring of contract monitors. For more information visit the Monitoring page here.
Remote Monitoring for Sponsor Monitors, Non-Yale Employees
- Yale New Haven Health System: Research Request for Medical Records Access
- Yale New Haven Health System: Confidentiality and Responsibility Agreement
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 Office of Quality Assurance and Training provides administrative support for the management and coordination of five review committees within the YCCI and Yale Cancer Center.
- The Protocol Review Committee (Yale Cancer Center)
- Protocol Life Cycle Subcommittee of the Protocol Review Committee (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:
Alyssa K. Gateman, MPH CCRP
Director of Quality Assurance
2 Church Street South, Suite 112