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. 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.

Our monitors are available to provide their expertise to ensure each study is conducted according to GCP guidelines and all other applicable regulations. They also work closely with the YCCI Multicenter Project Managers to act as a central coordinating site and deliver operational excellence for all of their studies.

Some of the various services provided by the monitors are listed below:

Site Initiation Visits
• Review operational aspects of the protocol with the investigator and clinical site staff
• Assist with providing detailed instructions for CRF/eCRF completion
• Review regulatory documents
• Discuss patient recruitment
• Review safety reporting
• Review handling of data queries
• Review drug and/or device management

Interim Monitoring Visits
• Review informed consent form completion
• Confirm HIPAA compliance
• Verify patient eligibility
• Monitor protocol violations/deviations
• Perform source documentation and CRF/eCRF data review
• Monitor adverse event reporting
• Handle query resolution
• Evaluate reasons for screen failure or withdrawal
• Review regulatory documents
• Perform drug and/or device accountability

Close-Out Visits
• Perform final source documentation and CRF/eCRF data review
• Reconcile regulatory documents
• Finalize adverse event documentation, patient disposition and query resolution
• Perform final study drug and/or device accountability and return or destruction
• Review with the site staff their obligations following study termination

Other
• Assistance with protocol design and implementation
• Setup and coordination of protocol-specific Data and Safety Monitoring Boards (DSMBs)
• Development of Data and Safety Monitoring Plans
• Assistance with identifying and hiring contract monitors
• Study startup activities