Clinical protocol and data management

Clinical Protocol and Data Management

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. This Resource coordinates closely with the Biostatistics Shared Resource, the Protocol Review and Monitoring System, Data and Safety Monitoring, the Cancer Research Informatics and Services Shared Resource and Massey Cancer Center Administration.

CPDMSR has four components:

• Director.
• Clinical Trials Office.
• 10 research teams (nine discipline-oriented and one geographic).
• Database management.

These components assist investigators by providing 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 the Cancer Research Informatics and Services Shared Resource, the Biostatistics Shared Resource and Administration).