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.

项目摘要/摘要 NIAID临床数据和安全管理中心（CDSMC）是合并的临床支持服务 中心构想管理NIAID的过敏性疾病临床研究组合，哮喘，自身免疫性 疾病和免疫介导的移植并发症，Rho支持的继续计划 先前的奖项。我们的愿景是通过继续我们的 在数据管理，安全和标本跟踪方面成功合作，重点是连续性 拥抱创新。在过去的二十年中，创新发生了巨大变化的临床试验操作， 随着技术革命的发展，试验数据系统和生物学的进步使研究停止 疾病过程。 RHO团队试图继续我们对Niaid的工作支持，以实现这一诺言。 自成立以来，Rho一直是临床数据，安全事件和生物测量跟踪中心。 Rho有 通过引入计算机数据系统的纸和传真提交时代的指导NIAID 并进入软件时代作为关键研究系统的服务（“ SaaS”）。在这段时间里，Rho有 始终专注于系统的成绩发展，以确保NIAID支持的研究能够使用 当前的研究管理中最佳实践，同时避免了过早采用的风险。 我们建议通过将CDSMC组织成四个核心来提供服务：行政管理 核心（AMC）将由科学的角度和计划主管由主要研究人员领导 从操作的角度来看。 AMC将监督CDSMC；管理运营，质量和 向NIAID报告的法规合规性；并协调DSMB支持NIAID和其他功能工作 区域。数据管理核心（DMC）将为数据收集提供战略和运营支持， 管理和处理；支持Rave EDC（Medidata，Inc。纽约，纽约）；开发ECRFS 建立研究数据库；并管理数据质量和研究数据生命周期。安全和 药物宣传中心（SPC）将接收，处理，分析和报告广告事件，并提供 综合的药物保护支持对NIAID支持的临床试验。 SPC将为 在研究设计和管理查询的产生和解决方面解决安全和药物养护， 叙事的一代，摘要报告和无盲。标本跟踪核心（STC）将告知 在研究设计过程中考虑标本处理和跟踪的考虑，并将支持跟踪和报告 在研究期间，利用我们制定NIAID目前使用的标本跟踪策略的经验 DAIT研究。根据我们支持NIAID资助的临床研究的悠久历史和我们的经验 将创新纳入临床研究以提供改进并避免风险，我们相信我们可以 有效地支持NIAID研究目标的实现。