Clinical Protocol and Data Management

The Cancer Clinical Research Office (CCRO) provides experienced and proficient coordination, administration, and reporting for all cancer clinical trials conducted at the Mayo Clinic Cancer Center (MCCC). The primary services provided by the CCRO, which include protocol development and maintenance, compliance, study coordination, and training/education, are fundamental to the clinical research activities of the MCCC. Staff in the CCRO work collaboratively with each MCCC program and many of the MCCC shared resources to provide expert, efficient support in the conduct of clinical research. The CCRO consists of four main areas which are integrated together to form an efficient, organized resource. The four areas are: 1) Protocol Management, which includes the development and maintenance of all protocol documents and the entry of protocol-specific data into the MCCC database for the purpose of tracking and reporting of study information; 2) Study Coordination, which includes the screening, enrolling, and management of clinical trial participants; 3) Compliance, which includes auditing, monitoring, and providing regulatory expertise; and 4) Quality Control, which includes training and education and ensuring data quality. These areas work effectively together on a daily basis to provide clinical trial collaboration, support, management, and dissemination of information to investigators and programs across the Mayo enterprise. Dr. Steven Alberts and Kelly Paulson are Co-Directors of the CCRO. A prominent attribute of the CCRO is the extensive integration and standardization among the MCCC campuses to provide collaborative support to MCCC investigators and programs. The integration of the MCCC across the Mayo enterprise (Arizona, Florida, Rochester) has required a unified CCRO, which consists of shared systems, standard operating procedures, structure, support, and the ability to provide cross-coverage in support of MCCC investigators. Future goals of the CCRO include continued efforts to improve the timelines, development, activation, and conduct of clinical trials.