Clinical Protocol and Data Management

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

Abstract

The objective of the Clinical Protocol and Data Management (CPDM) Shared Facility is to provide central management for the implementation, coordination, and conduct of UAB Cancer Center clinical trials developed by the UAB Cancer Center faculty and by extramural collaborators associated with SPOREs, other Cancer Centers, the NCI, private foundations, cooperative groups and industry. The CPDM accomplishes this objective by providing critical infrastructure to support the monitoring of trials, including all major aspects of quality assurance, and by providing a centralized database of protocol-specific data. CPDM adds value to the work of Cancer Center members by providing knowledgeable and professional support for investigators at all stages of experience with the clinical trials process. This robust infrastructure assures that all trials have excellent support in regulatory compliance, protocol adherence, and recruitment, especially minority recruitment. Demonstration of the quality of this shared resource can be seen through a number of objective measures. A recent audit showed UAB as outstanding in protocol adherence. Patient enrollment has increased, especially to investigator-initiated trials, and our minority enrollment is in larger proportion to our surrounding population. The CPDM has taken steps to improve the infrastructure, largely in response to the changes in faculty and research emphasis over the past five years, but also in response to the changing regulatory environment. The CPDM has worked with other parts of the center to implement OnCore, a comprehensive clinical and translational research management software. The CPDM has implemented a Clinical Trials Monitoring Committee to monitor active clinical trials in the Cancer Center at least monthly for safety and progress. The faculty also incorporated specialized Protocol Management Teams who have enhanced both nurse-physician interaction and accrual to trials in high-priority areas. n summary, the CPDM has expanded its capacities and aligned its focus with the changing needs of UAB Comprehensive Cancer Canter members, and continues to provide excellent coordinating and monitoring support.