Clinical Protocol and Data Management (CPDM) functions are carried out within the CFCCC’s Stern Center for Cancer Clinical Trials & Research, which houses the Clinical Trials Unit (CTU) and the Protocol Review & Regulatory Unit (RRU). Both offices provide a centralized mechanism to support CFCCC clinical research and aim to enhance the ability of CFCCC members to conduct clinical cancer research within all NCI, federal and state regulatory requirements. These offices facilitate and support the conduct of interventional and treatment clinical trials. RRU and CTU services are provided for the entire lifecycle of a research study, which includes development and implementation support, as well as quality control functions. In addition to assistance specifically related to the planning and conduct of study protocols, RRU and CTU work closely with the Clinical Informatics Department of UC Irvine Medical Center to manage the CFCCC clinical trials management system, OnCore, which houses protocol-specific data necessary for planning, reporting, and internal oversight, as well as tracking of activities, workloads and other key metrics.
The CTU provides central management and oversight assistance for coordinating and facilitating the study management needs for cancer clinical trials for the CFCCC. Clinical research coordinators (CRCs) are assigned to multiple specific disease-oriented teams (DOTs) to aid in the organization and operations of the clinical research enterprise and to provide workflow consistency to the Investigators conducting the trials. The CTU established three separate teams who each handle several disease sites.
CRCs assist Investigators by coordinating and executing clinical trial activities, which include:
The RRU provides central management and oversight assistance for coordinating the regulatory needs of cancer clinical trials. The office is separated into two components, committee coordination and regulatory submissions.
The committee coordinators manage the following administrative activities, which include:
The regulatory coordinators manage the following regulatory activities, which include:
Organization of the CPDM function:
Clinical Trials Unit Manager: Janis DeJohn
Protocol Review & Regulatory Unit: Kimberli Doan