Philadelphia HIV Therapeutics and Prevention Clinical Trials Unit

费城艾滋病毒治疗和预防临床试验单位

• 批准号: 10172693
• 负责人: Ian Frank
• 金额: $ 29.97万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-19 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10172693
• 关键词: Affect; Businesses; COVID-19; COVID-19 pandemic; Clinical; Clinical Research; Clinical Trials Unit; Employee; Ensure; Equipment; Exposure to; Face; HIV; Human Resources; Institution; Laboratories; Masks; Operations Research; Patients; Pennsylvania; Persons; Philadelphia; Prevention; Quarantine; Safety; Site; Testing; Therapeutic; Time; University Hospitals; Update; clinical trial participant; falls; high risk; operation; prevention clinical trial; risk minimization

ABSTRACT The pandemic of COVID-19 has had and will continue to have a profound impact in the research operations of the Philadelphia CTU and its associated CRSs (Therapeutic and Prevention) The Aim of this supplemental request is to facilitate the return of safe and efficient clinical Research operations at the Philadelphia CTU, critically affected by the COVID-19 epidemic. We anticipate the following needs for our CTU from now until December 1st, 2020: 1. Personnel. We anticipate needs of at least one Clinical Research Coordinator in both the Therapeutic and the Prevention CRS. This need is necessitated to maintain the clinical staff required to implement COVID-19 related clinical activities while regular HIV-related trials resume; and in order to minimize risks to workers among our current staff who are at higher risk for severe illness from COVID-19 who will require limited time “in office” and face-to-face exposure to clinical trial participants. 2. Clinical supplies to ensure the safety of our employees and the clinical trial participants (Personal protective equipment, masks, gloves, face shields etc.). We are also anticipating that our institution will increase the requirement for COVID-19 testing of our personnel and our clinical trials participants. 3. Increased personnel in the laboratory to allow it to remain operational in the case that one of our employees needs to be quarantined or falls sick in the following months. 4. Equipment and testing kits for the clinical laboratory at the hospital of the University of Pennsylvania to ensure that the increased testing needs associated with our clinical research operations do not tax the regular clinical operations of the laboratory.

抽象的 COVID-19 的大流行已经并将继续对以下机构的研究活动产生深远影响： 费城 CTU 及其相关 CRS（治疗和预防） 此补充请求的目的是促进安全高效的临床研究运营的恢复 费城 CTU 受到 COVID-19 疫情的严重影响。 从现在到 2020 年 12 月 1 日，我们预计 CTU 的需求如下： 1、人员。我们预计治疗和临床研究领域至少需要一名临床研究协调员 和预防 CRS。这种需要是维持实施所需的临床人员所必需的 COVID-19 相关临床活动，同时恢复定期 HIV 相关试验；并为了尽量减少 我们现有员工中因感染 COVID-19 而罹患严重疾病的风险较高的员工面临的风险 将需要有限的“在办公室”时间以及与临床试验参与者面对面的接触。 2. 确保我们员工和临床试验参与者安全的临床用品（个人） 防护设备、口罩、手套、面罩等）。我们也期待我们的机构 增加对我们的人员和临床试验参与者进行 COVID-19 检测的要求。 3. 增加实验室的人员，以使其在我们的其中一个实验室发生故障的情况下仍能继续运行 员工在接下来的几个月内需要隔离或生病。 4. 大学医院临床实验室设备及检测试剂盒 宾夕法尼亚州确保与我们的临床研究相关的测试需求增加 操作不会对实验室的常规临床操作造成负担。