CLINICAL RESEARCH OFFICE (SHARED RESOURCE)

临床研究办公室(CRO)协调临床研究的活动并提供监督 由癌症中心成员进行的研究。具体地说，共享资源的目标是： 协调癌症中心成员发起的临床研究，通过保证 有效的数据管理、药房支持、护理管理、IRB审批、记录保存、 实施和关闭。 收集并提供有关协议可用性、资格和应计费用的信息。 与适当的癌症中心项目负责人和机构临床负责人确定优先事项并进行协调 对癌症中心成员、合作小组(例如，GOG、SWOG、NSABP)和其他组织的研究 研究(例如，制药)。 对癌症中心的临床试验进行质量控制和内部审计。内部审计包括 监测1)遵守知情同意程序和规定的资格标准，2)适当 提供治疗和实施治疗修改，3)报告临床结果和 毒性，以及4)准确的数据记录和5)研究对象的保密。 为首席研究员提供个人临床研究信息学需求方面的帮助 协议。服务包括：确定必要的数据集；开发特定于研究的案例 报告表格；监测数据质量；与共享的生物统计数据起联络作用 资源，以便为统计分析提供数据。

The Clinical Research Office (CRO) coordinates the activities and provides oversight for clinical research studies conducted by Cancer Center Members. Specifically, the objectives of the Shared Resource are to: Coordinate the clinical research studies initiated by Cancer Center Members through assurance of effective data management, pharmacy support, nursing management, IRB approval, record keeping, implementation, and close-out. Gather and provide information on protocol availability, eligibility, and accrual. Prioritize and coordinate, with the appropriate Cancer Center Program Leaders institutional clinical studies of Cancer Center Members, those of cooperative groups (e.g., GOG, SWOG, NSABP) and other studies (e.g., pharmaceutical). Perform quality control and internal auditing for Cancer Center clinical trials. Internal audits include monitoring 1) compliance with the informed consent process and stated eligibility criteria, 2) appropriate delivery of treatment and implementation of treatment modifications, 3) reporting of clinical outcome and toxicity, and 4) accurate recording of data and 5) maintenance of research subject confidentiality. Provide assistance to Principal Investigators with clinical research informatics needs for their individual protocols. Services include: Identification of the necessary datasets; development of study-specific case report forms; monitoring of quality of data; and serving a liaison function with the Biostatistics Shared Resource for the purpose of providing data for statistical analysis.