CANCER TRIALS SUPPORT UNIT (CTSU) CORE SUPPORT SERVICES & THE CTSU ENTERPRISE OF SYSTEMS

承包商应提供操作、管理和信息 支持在多个机构开展0期至7期临床研究 3项癌症相关研究，包括： 1. 业务支助 a. 管理用户帐户，遵守配置管理指南，并操作和维护CTSU网站。 B. 操作客户服务支持帮助台，以支持有关CTSU运营各个方面的查询。 C. 组织工作组;包括政府、多中心组织（MCO）、其他合同员工或其他相关方;根据需要制定协作解决方案，以消除平行/重复的MCO和/或合同系统和流程，并改进冗余、低效或重复的活动。 D. 确定潜在的差距和/或机会，以补充CTSU的支持服务 e. 与NCI和MCO合作，确定并建立试验协调的标准、系统、程序和最佳实践。 F. 与传统上不合作的其他多中心组织和/或机构合作。 G. 提供MCO预算跟踪支持 H. 通过履行CTEP临床试验监查分支（CTMB）制定的稽查规则，执行研究中心稽查/中心监查 I. 提供符合NCI数据质量报告和药物临床试验质量管理规范（GCP）程序的工具和流程。 J. 制定国际合作管理最佳实践 K. 协调OMB许可 L. 提供监管文件跟踪、管理和支持 M. 提供方案文档/开发支持 n. 提供人员和研究中心名册支持 O. 提供临床数据管理系统支持（CDMS） 2. 信息（IT）支持 a. 提供CTSU-企业系统（ESYS）IT支持： B. 使用符合能力成熟度模型集成（CMMI）成熟度级别3的最佳实践。 C. 遵循卫生与公众服务部（HHS）企业绩效生命周期（EPLC）的所有实践，以增强IT治理。 D. 遵守所有与患者记录相关的法规要求。 e. 根据《联邦信息安全现代化法案》（FISMA）和HHS IT安全要求获得操作授权（ATO）。 F. 根据联邦政府法规提供系统/数据备份和灾难恢复。 G. 维护、更新、增强并提供培训（与认知、教育和培训承包商协调），以用于NCI开发的定制应用程序、经修改以满足NCI需求的商用现成应用程序，以及从其他应用程序集成到本任务下包含的应用程序 H. 遵循配置管理的最佳实践， I. 遵循项目管理的最佳实践。 J. 对于潜在的新应用程序或集成，与COR和主题专家（SME）合作，制定主要技术和操作要求的列表。 K. 对于潜在的新应用程序或集成，对可能满足项目需求的新IT计划的可用商用现成（COTS）解决方案进行分析，包括定制COTS解决方案。 承包者应： 1. 维护所有现有的全国覆盖率分析（NCA）和电子病历（EMR）材料。 2. 根据COR的指示，为特定研究创建新的NCA和EMR材料。 3. 由于方案修订，修改NCA和EMR材料。 4. 维护NCA和EMR文件的质量控制程序。 5. 为主要肿瘤中心和NCORP研究中心使用的通用EMR系统创建研究特定的、可共享的EMR模板，包括药物医嘱模板

The Contractor shall provide operational, regulatory and informatics support to conduct clinical studies across multiple institutions for Phase 0 through Phase 3 cancer-related studies to include: 1. Operational Support a. Manage user accounts, adhere to configuration management guidelines, and operate and maintain CTSU websites. b. Operate a customer service support help desk to support queries regarding all facets of CTSU operations. c. Organize working groups; including Government, Multicenter Organization (MCO), other contract staff, or other appropriate parties; as needed, to develop collaborative solutions to eliminate parallel/duplicative MCO and/or contract systems and processes and improvements for activities such as those that are redundant, inefficient, or duplicative. d. Identify potential gaps and or opportunities to supplement CTSU support services e. Collaborate with NCI and MCOs to identify and establish standards, systems, procedures, and best practices for trial coordination. f. Collaborate with other multi-center organization(s) and/or institutions that do not traditionally work together. g. Provide MCO budget tracking support h. Performing site auditing/central monitoring by fulfilling the auditing rules set by the Clinical Trials Monitoring Branch (CTMB) of CTEP i. Provide tools and processes that comply with NCI Data Quality Reporting and Good Clinical Practice (GCP) procedures. j. Develop International Collaboration Administrative Best Practices k. Coordinate OMB Clearances l. Provide regulatory document tracking, management, and support m. Provide protocol documentation/development support n. Provide person and site Roster Support o. Provide Clinical Data Management System Support (CDMS) 2. Information (IT) Support a. Provide CTSU-Enterprise System (ESYS) IT Support: b. Use best practices consistent with Capability Maturity Model Integration (CMMI) Maturity Level 3. c. Follow all Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) practices to enhance IT governance. d. Maintain compliance with all regulatory requirements concerning patient records. e. Secure an Authorization to Operate (ATO) in accordance with Federal Information Security Modernization Act (FISMA) and HHS IT Security requirements. f. Provide system/data back-up and disaster recovery in accordance with federal government regulations. g. Maintain, update, enhance, and provide training (in coordination with the Awareness, Education, and Training contractor) for NCI-developed custom applications, commercial-off-the-shelf applications modified to meet NCI needs, and integrations from other applications to the included applications under this task h. Follow best practices for configuration management located i. Follow best practices for project management. j. For potential new applications or integrations, work with the COR and subject matter experts (SMEs) to develop a list of major technical and operational requirements. k. For potential new applications or integrations, perform an analysis of available Commercial Off-the-Shelf (COTS) solutions for new IT initiatives that could potentially meet the project needs, to include customization of a COTS solution. The contractor shall: 1. Maintain all existing National Coverage Analysis (NCA) and Electronic Medical Record (EMR) materials. 2. Create new NCA and EMR materials for specific studies as directed by the COR. 3. Modify NCA and EMR materials due to protocol amendments. 4. Maintain a Quality Control Program for the NCA and EMR documents. 5. Create study specific, sharable EMR templates, including those for medication orders, for the common EMR systems used by major oncology centers and NCORP sites