Pre-Study Site Qualification Visits
- Draft study-specific site qualification questionnaires
- Review site resources, qualifications of staff and PI, facilities (if onsite)
- Provide regulatory documentation of site qualification for external sites
Monitoring
The YCCI Monitoring service provides expertise for monitoring the conduct and progress of investigator-initiated clinical trials, including multicenter trials for which Yale is the lead site. Our Monitors are available to provide study specific on-site or remote monitoring support to ensure data integrity, adequate protection of the rights and safety of human subjects, and compliance with the IRB approved protocol, GCP and applicable policies and regulators.
Our monitors are trained on GCP and federal regulations, use approved templates and SOPs, and distribute written reports for all completed monitoring visits. They also work closely with the YCCI Project Management and Data Management 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
- Review regulatory documents
- Discuss patient recruitment
- Train staff on expectations for safety reporting, source data collection and protocol compliance
- Review handling of data queries
- Review drug and/or device management, tracking and reconciliation
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 specimen tracking and/or shipping
- Review regulatory documents
- Perform drug and/or device accountability
Close-Out Visits
- Perform final source documentation and CRF/eCRF data review
- Review and reconcile regulatory documents
- Review finalization of 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
- Create study-specific monitoring plan
- Conduct unblinded investigational product and/or device monitoring
- Assistance with protocol design and implementation
- Study startup activities
- Staff training and research education
Monitoring Contact
Theresa Bouchard Goddard, CCRP, CHRC, Assistant Director, Monitoring