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CRU and Quality Improvement

The CTSI Clinical Research Unit (CRU) is building on our culture of Quality.  Ms. Michelle Adams, Quality Nursing Supervisor (and CRU Quality & Safety RN) is working with leadership and study PIs to further improve CRU unit processes and protocol management to 1) continue our alignment with UUHC QPS standards, 2) ensure fidelity to the protocol across study PIs and populations of all ages and illnesses, and 3) to provide consistent and detailed research care, dosing and documentation for the increasing complexities in clinical trials.  One recent Quality initiative:  The CRU has implemented a new internal event/protocol deviation reporting process that builds from our existing Safety Event Reporting process and document. The new format includes categories that align closely with U hospital clinical classifications, and has functionality that will allow improved reporting and monitoring of trends.  The system includes auto-notifications to specific individuals including leadership and PI's.  This streamlines process for immediate review, escalation (when needed), a CAPA plan, and ongoing CAPA assessment.  We’re excited about the benefits to protocol performance and CRU operations.