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.

承包商应提供母IDIQ工作说明书任务（任务区）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多中心项目进行的活性试验的TSDV。 试验活动基于前一个月的数据库操作（例如，数据捕获、查询、导出）。 B） 注：NCI目前在其大多数研究中使用Rave-Classic，在未来的某个时候，NCI可能会过渡到Rave-EDC。 承包商应支持相关的过渡活动，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）、 托管（任务2）和专业服务（任务4），约19个生产和测试URL，在参考#1中确定。NCI可以根据需要添加新的URL或修改现有的URL（任务5）。 d）、 专业服务（任务4）： 1. 向NCI承包商提供支持，以支持与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： （一） 临床试验支持单位（CTSU） （二） 临床试验监查服务（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：联盟拥有Rave支持服务的独立合同。 本NCI合同仅限于对Medidata辅助产品的支持。