CORE--CLINICAL RESEARCH MANAGEMENT FACILITY

$53,375P30FY2001CANIH

Wake Forest University, Winston Salem NC

Investigators

Linked publications & trials

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Abstract

The Clinical Research Management (CRM) shared resource of the Comprehensive Cancer Center incorporates three distinct functional operations to assist Cancer Center members in their innovative clinical research. The three operations are: 1) Clinical Research Management shared resource-CRM is responsible for all centralized data management activities related to clinical research for CCCWFU protocols, including centralized patient registration; patient eligibility confirmation; drug monitoring; data collection, maintenance, and distribution. CRM also provides oversight for the Protocol Review and Monitoring System (PRMS) and Protocol Specific Research Support (PSRS) functions, ensuring alliance with CCCWFU scientific strategy and data management. The CRM core resource provides critical oncology data management expertise allowing investigators access to high quality data management by staff trained in cancer research. 2) Protocol Review and Monitoring System (PRMS)-The CCCWFU PRMS evaluates all protocols for scientific excellence and prioritization relative to other protocols, while acting as a key information resource by providing investigators assistance and guidance in protocol development and compliance with NCI and FDA guidelines. The PRMS group maintains and manages the Oncology Research Information System (ORIS), a centralized information resource for protocol and patient data, and oversees internal (Cancer Center members, nurses, and physicians in other departments) and external (affiliate physicians, nurses, and physicians in other departments) and external (affiliate physicians, nurses and staff) communications (section 9.9). 3) Protocol Specific Research Support (PSRS)-The PSRS functions include patient recruitment, screening, compliance monitoring, and data collection and dissemination for pilot and innovative institutional studies (CCCWFU studies) (section 9.10). We request 2.55 full time equivalent employees (FTEs) to support the centralized data management functions related to CCCWFU protocols (#1), 1.4 FTEs to support PRMS functions (#2) and 3 FTEs for PSRS functions (#3).

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