Alterations and Renovations for Clinical Research Resources and Facilities

2017年，西弗吉尼亚州临床和转化研究所（WVCTSI）成立了西弗吉尼亚州临床试验中心。 卓越（COE）在西弗吉尼亚大学的健康科学中心。从那时起，有一个 临床试验活动大幅增加，积极试验的数量翻了一番，临床试验参与人数增加 与前五年相比增加了10倍。预计临床试验入组将 继续增加，需要COE的进一步增长。此外，在下一个供资周期（第11年至 （15）我们将在全国范围内推广COE服务。WVCTSI最近被选为国家 心脏、肺和血液研究所RECOVER队列，一项COVID后急性后遗症的观察性研究- 19. WVCTSI，特别是COE将负责管理其他10个站点（9个CTR和2个CTSA） 不同程度的临床试验基础设施。特遣队所属装备活动激增，需要作出改变， 对现有空间进行翻修，以优化服务提供和管理。完成改造 本项目拟进行的改造将确保实现以下具体目标。具体目标 (1)增加临床研究参与，改善服务提供。我们将创建一个额外的研究 检查室，并对现有检查室进行改进， 可以同时安排，并在研究团队附近，与增加的临床 研究活动预期。（2）提高临床研究的生产率，确保临床研究的保密性 团队拟议的空间翻修将考虑到目前开放式会议所缺乏的与会者保密性。 COE办公空间通过建立新的墙，工作区将划定，允许保密以及 更好地集中特遣队所属装备工作人员。此外，为协作工作定义的空间，对全州范围内的 将创建COE扩展。具体目标（3）利用电话会议改善以下方面的接入和连通性： 临床研究团队，并增加远程团队之间的协作。专门的电话会议空间， 用于临床研究的视听设备将增加远程医疗的使用和全州范围的通信 为临床试验理事会，使临床试验的效率和质量的监督在遥远的网站（见CRRF 核心部分的详细信息）。此外，该项目中提议的空间和设备将使新的远程保健成为可能， CRRF核心部分中提出的用于进行远程患者研究访视（适当时）的平台 (Aim（1）本次更新申请。最后，专门的电话会议空间将改善 NHLBI RECOVER队列研究中的远程临床研究团队。

In 2017, the West Virginia Clinical and Translational Institute (WVCTSI) established the Clinical Trials Center of Excellence (COE) at West Virginia University’s Health Sciences Center. Since that time, there has been a substantial increase in clinical trial activity with the numbers of active trials doubling and clinical trial participation increasing 10-fold compared with the previous 5-year period. It is anticipated that clinical trial enrollment will continue to increase, requiring further growth of the COE. In addition, during the next funding cycle (Years 11- 15), we will extend COE services statewide. WVCTSI has recently been chosen as a lead site for the National Heart, Lung, and Blood Institute RECOVER Cohort, an observational study of post-acute sequelae of COVID- 19. WVCTSI, specifically the COE will be responsible for management of 10 other sites (9 CTRs and 2 CTSAs) with varying degrees of clinical trials infrastructure. The explosion in COE activity requires alterations and renovations to the existing space to optimize service delivery and management. The completion of the alterations and renovations proposed in this project will ensure accomplishment of the following specific aims. Specific Aim (1) Increase clinical research participation and improve service delivery. We will create an additional research exam room and make improvements to the existing exam room such that multiple clinical trial participant visits can be scheduled concurrently and in close proximity to the research team, aligning with the increased clinical research activity expected. Specific Aim (2) Enhance productivity and ensure confidentiality for clinical research teams. The proposed space renovations will allow for participant confidentiality that is lacking in the current open COE office space. By erecting new walls, work areas will be delineated, allowing for confidentiality as well as better concentration of COE staff. In addition, defined space for collaborative work, so essential to the statewide COE expansion, will be created. Specific Aim (3) Utilize teleconferencing to improve access and connectivity for clinical research teams and increase collaboration among remote teams. Dedicated teleconferencing space and audio-visual equipment for clinical research will enable increased telehealth use and statewide communication for the Clinical Trials Council, enabling oversight of clinical trials efficiency and quality at distant sites (See CRRF Core Section for details). In addition, the space and equipment proposed in the project will enable new telehealth platforms for the conduct of remote patient study visits (when appropriate) proposed in the CRRF Core section (Aim 1) of this renewal application. Finally, dedicated teleconferencing space will improve the management of distant clinical research teams in the NHLBI RECOVER Cohort study.