Philadelphia HIV Therapeutics and Prevention Clinical Trials Unit

摘要 COVID-19大流行已经并将继续对本集团的研究业务产生深远影响。 费城CTU及其相关的CRS（治疗和预防） 本补充申请的目的是促进安全有效的临床研究操作的恢复 在费城反恐组，受到新冠肺炎疫情的严重影响。 从现在到2020年12月1日，我们预计CTU的需求如下： 1.人员的我们预计至少需要一名临床研究协调员， 预防CRS。这一需求是必要的，以维持实施所需的临床工作人员 在恢复常规艾滋病毒相关试验的同时开展COVID-19相关临床活动;为了最大限度地减少 我们现有员工中的工人面临的风险，他们因COVID-19而患重病的风险较高， 将需要有限的时间“在办公室”和面对面接触临床试验参与者。 2.确保员工和临床试验参与者安全的临床用品（个人 防护设备、面罩、手套、面罩等）。我们还预计，我们的机构将 提高对我们的人员和临床试验参与者进行COVID-19检测的要求。 3.增加了实验室的人员，以便在我们的一个人 雇员需要被隔离或在接下来的几个月里福尔斯生病。 4.为哥伦比亚大学医院的临床实验室提供设备和检测工具包 宾夕法尼亚州，以确保增加的测试需求与我们的临床研究 操作不对实验室的常规临床操作造成负担。

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.