SPIROMICS GIC Support

SPIROMICS GIC摘要 该应用程序建议为基因组学和信息学中心(GIC)提供基础设施支持和帮助 多中心亚群和中间结局指标的临床地点和调查人员 在COPD研究(SPIROMICS)中。SPIROMICS I招募了2981名年龄在40岁至80岁之间的参与者，其中包括 非吸烟者和吸烟者患有或不患有慢性阻塞性肺病。在研究中收集了数据、CT图像和生物显微镜 访问和参与者每季度都有电话联系，这一联系正在进行中。一份拨款申请以继续 对SPIROMICS II的研究进行了审查，并获得了可资助的优先分数。SPIROMICS II将包括 一次额外的诊所访问和持续的电话随访。因为SPIROMICS I的资金来源是 来自NHLBI的合同、生物制品和数据是联邦政府的财产，NHLBI有一个 确保它们得到适当存储和管理的既得利益。NHLBI还致力于 在SPIROMICS进行科学研究，从而与参与者保持联系，并支持 对手稿和研究基础设施进行统计分析。 GIC建议继续管理SPIROMICS数据和生物谱，进行统计分析 研究数据，在研究的操作和科学方面进行协作，并提供研究管理 和监管监督。我们对这项研究的主要贡献归结为以下具体目标： 目标1：生物群落的维护和管理。确保标本存储在 适当的条件，管理申请使用标本的过程，并拉出和运输 经指导委员会和NHLBI批准后，将标本交给调查人员。 目标2：研究管理和运营支持。安排和促进会议和会议 电话，支持研究委员会，监督SPIROMICS政策和程序，维护一个网站 这项研究支持继续与研究参与者接触，包括通过提供激励措施 与会者完成后续电话，继续支持抽象和 对研究终点的判断，并提供改进的CT图像维护系统。 目标3：数据管理和统计支持。管理和分发研究数据并进行 对稿件和演示文稿的统计分析。 目标4：监管监督。跟踪IRB批准，管理严重不良事件的报告， 确保数据和样本的使用符合每个参与者的知情同意，以及 向观察性研究监测委员会(OSMB)报告研究进展。 GIC负责了SPIROMICS I中的大部分活动。资助这项申请将使我们能够 扩大我们对这项研究的支持，更新程序，特别是数据管理系统，并 提高对手稿进行统计分析的能力。

SPIROMICS GIC ABSTRACT This application proposes infrastructure support for the Genomics and Informatics Center (GIC) and assistance to the clinical sites and investigators for the multi-center Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). SPIROMICS I enrolled a cohort of 2,981 participants aged 40-80, including non-smokers and smokers with or without COPD. Data, CT images and biospecimens were collected at study visits and participants had quarterly telephone contacts, which are ongoing. A grant application to continue the study as SPIROMICS II has been reviewed and received a fundable priority score. SPIROMICS II will include an additional clinic visit and continued telephone follow-up. Because SPIROMICS I was funded through contracts from NHLBI, the biospecimens and data are the property of the federal government and NHLBI has a vested interest in ensuring that they are stored and managed appropriately. NHLBI is also committed to the science being undertaken in SPIROMICS and thus to maintaining contact with participants and supporting statistical analysis for manuscripts and the infrastructure for the study. The GIC proposes to continue to manage SPIROMICS data and biospecimens, undertake statistical analyses of study data, collaborate in operational and scientific aspects of the study, and provide study management and regulatory oversight. Our principal contributions to the study are grouped into the following specific aims:  Aim 1: Maintenance and management of biospecimens. Ensure specimens are stored under appropriate conditions, manage the process of requesting use of specimens, and pull and ship specimens to investigators when approved by the Steering Committee and NHLBI.  Aim 2: Study management and operational support. Schedule and facilitate meetings and conference calls, support study committees, oversee SPIROMICS policies and procedures, maintain a web site for the study, support continued contact with study participants, including by providing incentives to participants for completion of follow-up telephone calls, continue support for abstraction and adjudication of study endpoints, and provide improved systems for maintenance of CT images.  Aim 3: Data management and statistical support. Manage and distribute study data and conduct statistical analyses for manuscripts and presentations.  Aim 4: Regulatory oversight. Track IRB approvals, manage reporting of serious adverse events, ensure use of data and specimens is in accordance with each participant's informed consent, and report on study progress to the Observational Study Monitoring Board (OSMB). The GIC was responsible for most of these activities in SPIROMICS I. Funding this application will enable us to expand our support for the study, to upgrade procedures, particularly the data management system, and to increase capacity in terms of undertaking statistical analyses for manuscripts.