QA, Compliance & Regulatory Affairs

YCCI quality assurance and safety monitoring was created to support investigators and improve the quality of clinical research at Yale. The Office of Quality Assurance (QA) and Monitoring supports review committee administrative support, IND/IDE management, study monitoring, clinical research billing QA, clinical research QA and clinicaltrials.gov support.

Clinicaltrials.gov Support Services
The ClinicalTrials.gov Protocol Registration System (PRS) is a web-based tool developed for submitting clinical trials information to ClinicalTrials.gov
Clinical Research Billing Compliance
Ensuring the appropriate billing of clinical research services is a multifaceted process and requires the support and participation of Principal Investigators, nurse coordinators, administrative offices, and sophisticated electronic systems.
IND/IDE Support
YCCI provides a comprehensive, centralized resource for FDA submission of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), with staff members and consultants with Industry experience who provide “soup to nuts” IND/IDE support.
Quality Assurance
YCCI Quality Assurance 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.
Monitoring
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.