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.

QA Activities

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

Monitoring

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.

Training

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:

  1. The Protocol Review Committee & Protocol Life Cycle Subcommittee (Yale Cancer Center)
  2. The Data and Safety Monitoring Committee (Yale Cancer Center)
  3. The Science and Safety Committee (YCCI)
  4. 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
203.785.3661                                                                        203.785.2902
alyssa.gateman@yale.edu                                                       susan.anderson@yale.edu