1) CRM Shared Resource (CRM - Section 9.1.7): CRM is responsible for all centralized oversight andcoordination of protocol and data management activities of CCCWFU clinical research. CRM providescentralized patient registration, patient eligibility confirmation, drug monitoring and informatics services.CRM also provides operational and logistical oversight for the Protocol Review and Monitoring System(PRMS), Protocol Specific Research Support (PSRS) and Data and Safety Monitoring functions (DSM),ensuring alignment with CCCWFU scientific strategy and adherence to regulatory mandates. CRMprovides quality control oversight of data management, providing investigators assurance of high quality,efficient data management by trained and supervised staff.2) Protocol Review and Monitoring System (PRMS - Section 9.2): PRMS supports protocol developmentand protocol monitoring. PRMS evaluates all protocols for scientific merit and prioritizes protocolsbased on explicit CCCWFU priorities. PRMS also provides investigators with guidance in protocol writingand compliance with NCI and FDA regulatory guidelines. PRMS facilitates communications amongCCCWFU members, nurses, and staff, as well as with affiliate physicians and staff.3) Protocol Specific Research Support (PSRS Section 9.3): The PSRS functions include patientrecruitment, screening, compliance monitoring, and data management for institutional investigatorinitiatedCCCWFU feasibility and Phase I trials.4) Data and Safety Monitoring (DSM - Section 12.0): DSM identifies issues related to safety before andduring the course of studies. DSM reviews data trends related to safety and protocol milestones thatmight require protocol suspension or termination. Two committees in oversight of DSM functions, onefor phase I and II studies, and a separate committee for phase III studies. Support for these DSMfunctions is provided through personnel in the CRM shared resource. The CCCWFU has an NCIapprovedDSM plan.

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Subcommittee G - Education (NCI)
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Wake Forest University Health Sciences
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