RhoFED CDSMC

RhoFED CDSMC

• 批准号: 10746084
• 负责人: Peter N. Schmidt
• 金额: $ 897.96万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-08 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10746084
• 关键词: Accountability; Achievement; Address; Adoption; Adverse event; Age; Allergic Disease; Area; Asthma; Autoimmune Diseases; Award; Biology; Budgets; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Computers; Data; Data Collection; Databases; Dedications; Development; Disease; Electronics; Ensure; Environment; Event; Evolution; Foundations; Funding; Generations; Goals; Hypersensitivity; Immune; Immune System Diseases; Immunologic Deficiency Syndromes; Immunology; Individual; Industry; Information Systems; International; Investments; Leadership; Life Cycle Stages; Mediating; Medidata; National Institute of Allergy and Infectious Disease; Nature; New York; Office of Administrative Management; Paper; Performance; Principal Investigator; Process; Recording of previous events; Reporting; Research; Research Design; Research Support; Resolution; Risk; Safety; Safety Management; Sampling; Scientist; Services; Specific qualifier value; Specimen; Specimen Handling; Structure; Summary Reports; System; Technology; Time; Transplantation; United States National Institutes of Health; Vision; Work; Xenograft procedure; allotransplant; congenital immunodeficiency; data management; data quality; electronic data; experience; immune function; improved; innovation; insight; meetings; operation; organizational structure; pharmacovigilance; prevent; process improvement; programs; rho; service organization; software as a service; systems research

PROJECT SUMMARY/ABSTRACT The NIAID Clinical Data and Safety Management Center (CDSMC) is a consolidated clinical support service center conceived to manage NIAID’s portfolio of clinical research in allergic diseases, asthma, autoimmune disorders, and immune-mediated complications of transplant, continuing programs supported by Rho under prior awards. Our vision is to advance NIAID’s history of successful clinical research by continuing our successful collaboration in data management, safety, and specimen tracking with a focus on continuity while embracing innovation. Over the last two decades, innovation has dramatically changed clinical trial operations, with the technology revolution advancing trial data systems and advances in biology enabling research to halt disease processes. The Rho team seeks to continue our support of NIAID’s work to deliver on this promise. Rho has served as a clinical data, safety event, and biospecimen tracking center since its founding. Rho has guided NIAID from the age of paper and FAX submissions through the introduction of computer data systems and into the era of Software as a Service (“SaaS”) hosting of critical research systems. Over this time, Rho has always focused on gradual evolution of systems to ensure that NIAID-supported research has access to the current best practices in study management while avoiding the risks of too early adoption. We propose to provide services by organizing the CDSMC into four cores: an Administrative Management Core (AMC) that will be led by the Principal Investigator from a scientific perspective and the Program Director from an operations perspective. The AMC will oversee the CDSMC; manage operational, quality, and regulatory compliance reporting to NIAID; and coordinate DSMB support with NIAID and other functional work areas. The Data Management Core (DMC) will provide strategic and operational support for data collection, management, and processing; support the Rave EDC (Medidata, Inc. New York, NY); develop eCRFs and build study databases; and manage data quality and the study data lifecycle. The Safety and Pharmacovigilance Center (SPC) will receive, process, analyze, and report adverse events and provide comprehensive pharmacovigilance support to NIAID-supported clinical trials. The SPC will provide support for addressing safety and pharmacovigilance during study design and manage query generation and resolution, narrative generation, summary reporting, and unblinding. The Specimen Tracking Core (STC) will inform considerations of specimen handling and tracking during study design and will support tracking and reporting during studies, leveraging our experience developing the specimen tracking strategy currently used in NIAID DAIT studies. Based on our long history of supporting NIAID-funded clinical research and our experience incorporating innovation into clinical research to deliver improvement and avoid risk, we believe we can effectively support the achievement of NIAID’s research goals.

项目概要/摘要 NIAID 临床数据和安全管理中心 (CDSMC) 是一个综合临床支持服务机构 该中心旨在管理 NIAID 在过敏性疾病、哮喘、自身免疫性疾病方面的临床研究组合 疾病和免疫介导的移植并发症，由 Rho 支持的持续项目 之前的奖项。我们的愿景是通过继续我们的努力来推进 NIAID 成功临床研究的历史 在数据管理、安全和样本追踪方面的成功合作，重点关注连续性，同时 拥抱创新。在过去的二十年中，创新极大地改变了临床试验操作， 随着技术革命推进试验数据系统和生物学的进步使研究停止 疾病过程。 Rho 团队寻求继续支持 NIAID 的工作，以兑现这一承诺。 Rho 自成立以来一直充当临床数据、安全事件和生物样本追踪中心。罗有 引导 NIAID 从纸质和传真提交时代引入计算机数据系统 并进入关键研究系统托管的软件即服务（“SaaS”）时代。这段时间，罗 始终专注于系统的逐步演进，以确保 NIAID 支持的研究能够获得 当前研究管理的最佳实践，同时避免过早采用的风险。 我们建议将CDSMC组织成四个核心来提供服务： 行政管理 核心（AMC）将由首席研究员从科学角度和项目总监领导 从运营的角度来看。 AMC 将监督 CDSMC；管理运营、质量和 向 NIAID 报告监管合规情况；并协调 DSMB 支持与 NIAID 和其他功能性工作 地区。数据管理核心（DMC）将为数据收集提供战略和运营支持， 管理、加工；支持 Rave EDC（纽约州纽约市 Medidata, Inc.）；开发 eCRF 并 建立研究数据库；管理数据质量和研究数据生命周期。安全和 药物警戒中心 (SPC) 将接收、处理、分析和报告不良事件，并提供 为 NIAID 支持的临床试验提供全面的药物警戒支持。最高人民法院将提供支持 在研究设计过程中解决安全性和药物警戒问题并管理查询生成和解决， 叙述生成、摘要报告和揭盲。样本追踪核心 (STC) 将通知 在研究设计期间考虑样本处理和跟踪，并将支持跟踪和报告 在研究期间，利用我们开发 NIAID 目前使用的样本追踪策略的经验 DAIT 研究。基于我们支持 NIAID 资助的临床研究的悠久历史和我们的经验 将创新融入临床研究以实现改进并避免风险，我们相信我们可以 有效支持NIAID研究目标的实现。