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. 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.
The QA office provides training and educational instruction to augment the education provided institutionally. Activities include:
- Online Good Clinical Practice (GCP) training, supplemented by periodic face-to-face sessions.
- Two monthly series offering presentations from experts on topics related to conducting clinical research, including QA.
- A three-part introduction to clinical research that includes QA and the roles of Yale’s institutional review committees related to clinical research.
- Symposia and presentations for clinical research faculty and staff on topics related to conducting high-quality clinical research. These are periodically scheduled throughout the year.
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: Training Contact:
Alyssa Gateman Susan Anderson
Director of Quality Assurance Director of Training
2 Church Street South, Suite 112 2 Church Street South, Suite 112