Clinical Protocol and Data Management

癌症临床研究办公室（CCRO）为在马约诊所癌症中心（MCCC）进行的所有癌症临床试验提供经验丰富的协调、管理和报告。CCRO提供的主要服务，包括方案制定和维护、依从性、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项目合作，许多MCCC共享资源，为临床研究的开展提供专家，有效的支持。CRO由四个主要领域组成，这些领域被整合在一起，形成一个有效的、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，包括临床试验参与者的筛选、入组和管理; 3）合规性，包括稽查、监查和提供监管专业知识;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协同工作，为整个马约企业的研究者和项目提供临床试验协作、支持、管理和信息传播。 博士史蒂文·艾伯茨和凯利·保尔森是CRO的联合董事。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研究人员和项目提供协作支持。跨马约企业（亚利桑那州、佛罗里达州、罗切斯特州）的MCCC整合需要一个统一的CCRO，该CCRO由共享系统、标准操作程序、结构、支持以及提供交叉覆盖以支持MCCC调查人员的能力组成。CCRO的未来目标包括继续努力改善临床试验的时间表、开发、激活和实施。

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.