Clinical Protocol and Data Management

癌症临床研究办公室(CCRO)为梅奥临床癌症中心(MCCC)进行的所有癌症临床试验提供经验丰富和熟练的协调、管理和报告。CCRO提供的主要服务，包括方案制定和维护、遵从性、研究协调和培训/教育，是MCCC临床研究活动的基础。CCRO的工作人员与每个MCCC计划合作，许多MCCC共享资源，在临床研究的进行中提供专业、高效的支持。CCRO由四个主要领域组成，这四个领域整合在一起，形成了一个有效、有组织的资源。这四个领域是：1)方案管理，包括所有方案文件的开发和维护，以及将方案特定数据输入MCCC数据库，以跟踪和报告研究信息；2)研究协调，包括对临床试验参与者的筛选、登记和管理；3)合规性，包括审计、监测和提供监管专业知识；以及4)质量控制，包括培训和教育，以及确保数据质量。这些领域每天有效地合作，为整个梅奥企业的研究人员和项目提供临床试验协作、支持、管理和信息传播。 史蒂文·阿尔伯茨博士和凯利·保尔森是CCRO的联席主任。CCRO的一个突出特点是MCCC校园之间的广泛整合和标准化，为MCCC的研究人员和项目提供协作支持。MCCC在Mayo企业(亚利桑那州、佛罗里达州、罗切斯特)的整合需要一个统一的CCRO，它包括共享系统、标准操作程序、结构、支持和提供交叉覆盖以支持MCCC调查人员的能力。CCRO的未来目标包括继续努力改进临床试验的时间表、开发、激活和进行。

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.