Clinical Protocol and Data Management

University Of Arizona, Tucson AZ

Investigators

Linked publications, trials & patents

Abstract

Project Summary / Abstract: Clinical Protocol and Data Management (CPDM) The Clinical Trials Office (CTO) at the University of Arizona Cancer Center (UACC) is the operational equivalent of the CPDM. It provides a centralized and comprehensive infrastructure for the conduct of clinical trials involving cancer patients. The CTO oversees institutional, externally peer-reviewed, National Clinical Trials Network (NCTN), and industry-sponsored studies. While treatment interventional trials are of major interest to the Cancer Center, the CTO also assists in the execution of trials with a broad range of other objectives, including diagnostics, cancer screening, basic science, health services, cancer prevention, and supportive care. The research supported by the CTO serves both adult and pediatric populations. The UACC has invested substantial support in the CTO to enable the management of important interventional trials, their associated accruals, and the increasing complexity of clinical trials. The CTO functions as a central administrative office for the implementation and conduct of internally and externally funded adult and pediatric oncology studies. Review and approval of protocols is performed by the Disease-Oriented Teams (DOTs) or Multidisciplinary Teams (MDTs), and the Scientific Review Committee and is required of UACC investigations prior to activation. There are nine designated DOTs and four that evaluate new protocols and monitor accrual for ongoing studies. The CTO also maintains and assures the quality of data regarding cancer clinical trial activation and accrual throughout the University. The CTO is led by well-qualified leadership and is subdivided into four major research support groups: 1) Review Committee and Regulatory Support Management; 2) Clinical Research Finance and Administrative Management; 3) Clinical Research, Data, and Biospecimen Management; and 4) Research Compliance / Quality Management. Clinical research support staff are positioned to effectively manage all processes of the trial lifecycle, and the CTO is organized in a manner that facilitates continuous improvement. The CTO has defined timelines for study activation that are important to maintain efficiency and effectiveness in conducting clinical research. The CTO maintains standard operating procedures (SOPs) and workflows that describe work processes conducted by the staff. The CTO facilitates the adoption of technology to increase operational efficiencies and quality management practices for supporting clinical research. The SOPs of the CTO stipulate that the CTO will conduct regularly scheduled internal reviews of protocol records. Since the last review period, the CTO expanded its capacity significantly to more appropriately oversee the trials currently open, and in preparation for a significant expansion of new faculty recruitment, the Phase I Program, and the community-based network of affiliate organizations. The UACC CTO adheres to the NIH policy that women and members of minority groups and their subpopulations be included in clinical research and supports increasing access to clinical research for children, consistent with the NIH recommendations. Data and safety monitoring support is provided for clinical trials.