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

癌症试验支持单位 (CTSU) 核心支持服务

• 批准号: 10806115
• 负责人: MARTHA HERING
• 金额: $ 1738.56万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10806115
• 关键词: Amendment; Authorization documentation; Awareness; Budgets; Cancer Therapy Evaluation Program; Cancer Trials Support Unit; Clinical Data; Clinical Research; Collaborations; Computerized Medical Record; Contractor; Contracts; Custom; Data; Data Management Resources; Data Security; Development; Disasters; Education; Federal Government; Good Clinical Practice; Government; Government regulations; Guidelines; Health; Human; Informatics; Information Services; Institution; International; Life Cycle Stages; Malignant Neoplasms; Modeling; Modernization; Monitor; Monitoring Clinical Trials; Oncology; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Procedures; Process; Protocols documentation; Quality Control; Records; Recovery; Reporting; Secure; Services; Site; Support System; System; Training; United States Dept. of Health and Human Services; Update; Work; authority; data quality; electronic medical record system; improved; operation; programs; tool; web site; working group

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

承包商应提供运营、监管和信息学 支持跨多个机构进行0期至6期的临床研究 3项与癌症相关的研究包括： 1.运营保障 A.管理用户账户，遵守配置管理指南，运营和维护CTSU网站。 B.运营客户服务支持服务台，以支持有关CTSU操作的所有方面的查询。 C.组织工作组；包括政府、多中心组织(MCO)、其他合同工作人员或其他适当的各方；根据需要开发协作解决方案，以消除平行/重复的MCO和/或合同系统和流程，并改进那些重复、低效或重复的活动。 D.查明补充反恐特设局支助服务的潜在差距和/或机会 与NCI和MCO合作，确定和建立试验协调的标准、系统、程序和最佳实践。 F.与其他多中心组织(S)和/或传统上不合作的机构合作。 G.提供MCO预算跟踪支持 H.通过遵守CTEP临床试验监测分部(CTMB)制定的审计规则进行现场审计/中央监测 I.提供符合NCI数据质量报告和良好临床实践(GCP)程序的工具和流程。 J.制定国际协作管理最佳做法 K.协调OMB许可 L。提供规范性文件跟踪、管理和支持 M.提供协议文档/开发支持 N.提供人员和现场花名册支持 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.使用与能力成熟度模型集成(CMMI)成熟度级别3一致的最佳实践。 C.遵循卫生与公众服务部(HHS)的所有企业绩效生命周期(EPLC)实践，以加强IT治理。 D.遵守所有有关患者记录的法规要求。 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.根据联邦政府规定提供系统/数据备份和灾难恢复。 G.(与意识、教育和培训承包商协调)维护、更新、增强NCI开发的定制应用程序、为满足NCI需求而修改的商业现成应用程序，以及将其他应用程序集成到本任务中包含的应用程序，并提供培训 H.遵循配置管理的最佳实践 遵循项目管理的最佳实践。 J.对于潜在的新应用或集成，与COR和主题专家(SME)合作，制定主要技术和操作要求清单。 K.对于潜在的新应用程序或集成，执行针对可能满足项目需求的新IT计划的可用商业现成(COTS)解决方案的分析，包括定制COTS解决方案。 承包商应： 1.维护所有现有的国家覆盖分析(NCA)和电子病历(EMR)材料。 2.根据COR的指示，为具体研究创建新的NCA和EMR材料。 3.因协议修改而修改NCA和EMR材料。 4.维护NCA和EMR文件的质量控制程序。 5.为主要肿瘤学中心和NCORP站点使用的常见EMR系统创建特定于研究的、可共享的EMR模板，包括用于药物订单的模板