RhoFED CDSMC

项目总结/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、 疾病和免疫介导的移植并发症，继续由Rho支持的计划， 以前的奖项。我们的愿景是继续推进NIAID的成功临床研究的历史， 在数据管理、安全性和样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里，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， 疾病过程。Rho团队寻求继续支持NIAID的工作，以实现这一承诺。 Rho自成立以来一直担任临床数据，安全事件和生物标本跟踪中心。Rho有 引导NIAID从纸张和传真提交到计算机数据系统的引入 并进入软件即服务（“SaaS”）托管关键研究系统的时代。在此期间，Rho 一直专注于系统的逐步发展，以确保NIAID支持的研究能够获得 研究管理中的当前最佳实践，同时避免过早采用的风险。 我们建议透过把社区发展管理委员会组织成四个核心来提供服务： 核心（AMC）将由主要研究者从科学角度和项目主任领导 从运营的角度来看。AMC将监督CDSMC;管理运营、质量和 向NIAID进行合规报告;并协调DSMB与NIAID的支持和其他职能工作 地区数据管理核心（DMC）将为数据收集提供战略和业务支持， 管理和处理;支持Rave EDC（Medidata，Inc.纽约）;编制eCRF， 建立研究数据库;管理数据质量和研究数据生命周期。的安全性和 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。SPC将支持 在研究设计期间解决安全性和药物警戒问题，并管理质询生成和解决， 叙述生成、总结报告和揭盲。样本跟踪核心（STC）将通知 在研究设计期间考虑标本处理和跟踪，并将支持跟踪和报告 在研究期间，利用我们开发NIAID目前使用的标本追踪策略的经验 DAIT研究。基于我们长期支持NIAID资助的临床研究的历史和我们的经验， 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的研究目标的实现。

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.