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