Quality Assurance & Monitoring
YCCI has partnered with the Yale Human Subjects Protection Program (HRPP) 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 Monitoring supports review committee administrative support, study monitoring, and QA specialists.
The YCCI Quality Assurance and Monitoring service provides expertise for centralized monitoring of investigator-initiated clinical trials, including multicenter trials for which Yale is the lead site.
QA Specialists are available to consult with investigators, upon request, on quality-related issues and protocol compliance; provide their expertise to confirm study conduct is according to Federal regulations, ICH GCP guidelines, university policies and all other applicable regulations and provide feedback and suggestions.
The YCCI resources and support are designed to help support and reduce the regulatory and reporting burden on investigators and teams before, during, and after inspections.
Sponsor monitors are allowed to access the Yale enterprise-wide Electronic Health Record (EHR) for source data verification.