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的大流行曾经并将继续对研究行动产生深远的影响 费城CTU及其相关的CRS（治疗和预防） 此补充请求的目的是促进安全有效的临床研究操作的回归 在费城CTU，受到19号流行病的严重影响。 我们预计从现在到2020年12月1日，我们的CTU有以下需求： 1。人员。我们预计在治疗中至少需要一个临床研究协调员 和预防CR。这种需求对于维护实施所需的临床人员是必需的 COVID-19相关的临床活动，而常规的HIV相关试验恢复；为了最小化 我们目前员工中的工人风险较高，他们患严重疾病的风险较高 will require limited time “in office” and face-to-face exposure to clinical trial participants. 2。临床用品，以确保员工和临床试验参与者的安全（个人 防护设备，口罩，手套，面罩等）。我们还期望我们的机构将 增加对我们人员和临床试验参与者的共同测试的需求。 3。实验室中增加的人，以使其能够在我们的一个情况下保持运营 在接下来的几个月中，员工需要隔离或生病。 4.大学医院临床实验室的设备和测试套件 宾夕法尼亚州，以确保与我们的临床研究相关的增加测试需求 操作不对实验室的定期临床操作征税。