HOSTING, MAINTENANCE AND PROFESSIONAL SERVICES FOR RAVE AND MEDIDATA RAVE INTEGRATED ANCILLARY SOFTWARE FOR NCI'S CANCER THERAPY EVALUATION PROGRAM (CTEP)

用于 NCI 癌症治疗评估计划 (CTEP) 的 RAVE 和 Medidata RAVE 集成辅助软件的托管、维护和专业服务

• 批准号: 10934067
• 负责人: WALT LEE
• 金额: $ 987.25万
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10934067
• 关键词: Area; Cancer Therapy Evaluation Program; Clinical Trials Support Unit; Computer software; Contractor; Contracts; Data; Databases; Development; Ensure; Future; Maintenance; Medidata; Monitoring Clinical Trials; Parents; Production; Services; Standardization; Support System; Systems Integration; Testing; Time; programs

The Contractor shall provide the Parent IDIQ SOW Tasks (Task Areas) 1, 2, 3, 4, and 5 as further described below: a) Hosting (Task 2) and maintenance (Task 3) for Rave-Classic (or RaveEDC), and TSDV for active trials conducted by the NCI multi-center program. Trial activity is based on database action during the prior month (ex. data capture, query, export). b) Note: NCI is currently using Rave-Classic for majority of its studies and at some time in the future NCI may transition to Rave-EDC. The contractor shall support relevant transition activities and provide professional support for RAVE-EDC as needed under a Task Order. NCI is already using Rave-EDC for some studies. c) Hosting (Task 2) and professional services (Task 4) for approximately 19 production and test URLs, identified in Reference #1. The NCI may add new URLs or modify existing ones as needed (Task 5). d) Professional services (Task 4): 1. To NCI contractors in support of system integration with NCI CORE applications 2. To the following NCI contractors for hosting, maintenance, and study development/management: (1) Clinical Trials Support Unit (CTSU) (2) Clinical Trials Monitoring Service (CTMS) 3. To ensure consistency, standardization, and best practices across the NCI multi-center URL holders (see reference #1) and the Alliance Network. Note: the Alliance has an independent contract for Rave support services. This NCI contract is limited to support for Medidata ancillary products.

承包商应提供父级 IDIQ SOW 任务（任务领域）1、2、3、4 和 5，如下所述： a) Rave-Classic（或 RaveEDC）的托管（任务 2）和维护（任务 3），以及 NCI 多中心项目进行的主动试验的 TSDV。 试用活动基于上个月的数据库操作（例如数据捕获、查询、导出）。 b) 注意：NCI 目前在其大部分研究中使用 Rave-Classic，并且在未来的某个时候 NCI 可能会过渡到 Rave-EDC。 承包商应支持相关过渡活动，并根据任务订单的需要为 RAVE-EDC 提供专业支持。 NCI 已经在一些研究中使用 Rave-EDC。 c) 大约 19 个生产和测试 URL 的托管（任务 2）和专业服务（任务 4），如参考文献 #1 中所确定。 NCI 可以根据需要添加新 URL 或修改现有 URL（任务 5）。 d) 专业服务（任务 4）： 1. NCI 承包商支持 NCI CORE 应用程序的系统集成 2. 以下 NCI 承包商负责托管、维护和研究开发/管理： (1) 临床试验支持单位(CTSU) (2) 临床试验监测服务（CTMS） 3. 确保 NCI 多中心 URL 持有者（参见参考文献 #1）和联盟网络的一致性、标准化和最佳实践。 注意：联盟拥有 Rave 支持服务的独立合同。 该 NCI 合同仅限于支持 Medidata 辅助产品。