The Incidence and Etiology of Influenza-Associated Pneumonia in Hospitalized Pers

描述(申请人提供)：作为该研究项目的协调中心，范德比尔特大学医学中心疫苗研究项目(VUMC-VVRP)将负责在小门罗卡瑞尔的范德比尔特大学医院进行这项研究的总体工作。范德比尔特儿童医院、浸信医院、圣托马斯医院和顶峰医疗中心。每个地点的现场调查员都提供了支持信，描述了他们在这个研究项目中的角色，这些信包括在我们的申请包中。在本项目过程中，VUMC-VVRP监管合规小组将与首席调查员合作，在整个执行期内提供文件控制。在这一角色中，合规团队将向各自的IRBs提交所有文件，并将IRB批准的协议、知情同意文件、案例报告表和其他关键文件分发给所有绩效地点的关键人员。此外，合规经理、质量保证经理和研究协调员将在研究项目实施之前向所有医院的工作人员提供强制性研究特定培训。首席调查员和研究协调员将对知情同意过程进行审计，并在整个登记期间进行相应的记录，还将对康复探视进行进一步审计。此外，研究协调员将在研究登记阶段每周与护士和研究协调员建立和举行常设会议。这些会议旨在讨论每个站点的目标和当前注册人数，以及本周遇到的任何障碍。质量控制审核将由VUMC-VVRP质量保证经理执行，绩效计划包含在本申请的附录中。将根据协调员会议和质量审计的结果，视需要提供额外培训。将通过圣托马斯研究所(STRI)与浸信会医院和圣托马斯医院签订分包合同。我们的申请中还包括了STRI的组织结构和治理的副本。所有致力于该项目的工作人员将遵循联邦工作报告指南，未经资助机构事先批准，不得加班。与STRI的分包合同将以费用补偿为基础，合同工作人员在收到范德比尔特大学医学中心的资金之前，将被要求提供工作人员工作时间的充分文件。 公共卫生相关性：在这项研究中，我们将招募1000名成人和300名儿童因肺炎住院并经胸部X光检查证实，以了解该地区肺炎的总体发病率、责任微生物以及流感感染对肺炎发病率的影响。

DESCRIPTION (provided by applicant): As the coordinating center for this research project, the Vanderbilt University Medical Center Vaccine Research Program (VUMC-VVRP) will be responsible for the overall conduct of the study at Vanderbilt University Hospital, Monroe Carell Jr. Children's Hospital at Vanderbilt, Baptist Hospital, St. Thomas Hospital, and Summit Medical Center. Site investigators at each of these sites have provided letters of support describing their roles in this research project and those letters are included in our application packet. During the course of this project, the VUMC-VVRP Regulatory Compliance team will work with the principal investigator to provide document control throughout the performance period. In this role, the compliance team will submit all documents to the respective IRBs and distribute IRB-approved protocols, informed consent documents, case report forms, and other critical documents to key personnel at all performance sites. Additionally, the compliance manager, quality assurance manager, and study coordinator will provide mandatory study-specific training to staff at all hospitals prior to the implementation of the research project. The informed consent process will be audited by the principal investigator and study coordinator and documented accordingly throughout the enrollment period and further auditing of convalescent visits will be performed as well. Additionally, the study coordinator will establish and hold standing meetings with the nurses and research coordinators on a weekly basis during the enrollment phase of the study. These meetings will be designed to discuss target and current enrollment for each site, as well as any barriers encountered during the week. Quality control audits will be performed by the VUMC-VVRP quality assurance manager and the performance plan is included in the appendix of this application. Additional training will be provided as needed based on findings from the coordinator meetings and the quality audits. Subcontracts will be established with Baptist and St. Thomas Hospitals through the St. Thomas Research Institute (STRI). A copy of the organizational structure and governance of STRI is also included in our application. All staff dedicated to this project will follow federal effort reporting guidelines and overtime will not be allowed without prior approval from the funding agency. The subcontract with STRI will be cost-reimbursement based and contracting staff will be required to provide adequate documentation of time worked by staff prior to receiving funds from Vanderbilt University Medical Center. PUBLIC HEALTH RELEVANCE: In this study we will enroll 1000 adults and 300 children hospitalized with pneumonia that is confirmed by chest X-ray to find the overall rates of pneumonia in the area, the microbes responsible, and the impact of influenza infection on pneumonia rates.