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 Research Office (CRO) and the Regulatory Affairs Office (RAO). 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. RAO and CRO 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, RAO and CRO 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 CRO 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 CRO established three separate teams who each handle several disease sites.
CRCs assist Investigators by coordinating and executing clinical trial activities, which include:
The RAO 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 Research Office Manager: Janis DeJohn
Regulatory Affairs Manager: Cynthia Mann