Clinical Protocol and Data Management

$54,519P30FY2009CANIH

Virginia Commonwealth University, Richmond VA

Investigators

Linked publications & trials

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Abstract

The Clinical Protocol and Data Management Shared Resource (CPDMSR) provides central management and oversight functions for coordinating, facilitating, and reporting on Cancer Center clinical trials as well as support for quality assurance mechanisms. The CPDMSR coordinates closely with the Biostatistics Shared Resource (BSR), the Protocol Review and Monitoring System (PRMS), Data and Safety Monitoring (DSM), the Cancer Research Informatics and Services (CRIS) Shared Resource, and Cancer Center Administration. CPDMSR has four components: [unreadable] Director [unreadable] Clinical Trials Office (CTO) [unreadable] Ten Research Teams (9 discipline-oriented and 1 geographic) [unreadable] Database Management. These components assist investigators through the following services: [unreadable] Development and management of sponsor relations (grants, contracts, compliance) [unreadable] Compliance with internal and external regulatory authorities (PRMS, IRB, NIH, CTEP, FDA, etc.) [unreadable] Communications [unreadable] Continuing education with regard to evolving practice and regulatory standards in clinical research [unreadable] Research nursing and data management oversight [unreadable] Protocol specific research nursing and data management [unreadable] Development and maintenance of databases for clinical research (a collaborative effort with the Cancer Research Informatics and Services Shared Resource (CRIS), the Biostatistics Shared Resource (BSR), and Administration).

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