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.
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.
