Clinical Protocol and Data Management

CPDM PROJECT SUMMARY/ABSTRACT The Clinical Protocol and Data Management (CPDM) efforts of the Holden Comprehensive Cancer Center (HCCC) are managed through two related components – Clinical Research Services (CRS) and Data and Safety Monitoring (DSM). These components have grown and strengthened significantly over the prior funding period. They are critical to the mission of the HCCC and support HCCC clinical cancer research including treatment, non-treatment interventional and non-interventional studies. They encompass clinical research, regulatory, and data and safety monitoring. This includes investigator-initiated trials (IITs), National Clinical Trials Network (NCTN) trials, consortium trials, and industry sponsored trials. Services provided by the CRS related to protocol management include protocol selection, development, routing, modification and adverse event monitoring. The CRS also provides trial specific support through staff that assist in assignment of trials to teams, protocol listing and promotion, accrual tracking, assistance with screening and consenting subjects, data management, quality assurance, and education for early career clinical investigators. The CRS works closely with other shared research resources to support translational cancer research, particularly Biostatistics (Biostats) and the Biospecimens Procurement and Molecular Epidemiology Resource (BioMER). A new component of the CRS is the Radiology Core Lab (RCL) that provides quantitative imaging services for clinical trials. DSM is coordinated through HCCC’s DSM Committee. The DSM has a distinct function from the Protocol Review and Monitoring Committee and IRB. DSM focuses on IITs and ensures the development of an acceptable data and safety monitoring plan, assesses subject safety, monitors clinical trial data veracity and protocol adherence, and provides education to investigators. CPDM also solicits feedback and responds to that feedback by providing innovative infrastructure that meets the needs of clinical investigators.