Core D: Clinical Recruitment

核心 D：临床招募

• 批准号: 10317019
• 负责人: Albert C Shaw
• 金额: $ 64.28万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-18 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10317019
• 关键词: 21 year old; Adherence; Adult; Age; Archives; Area; Bar Codes; Bioinformatics; Biological; Blood; COVID-19; Clinical; Code; Connecticut; Consent Forms; Data Analyses; Data Management Resources; Data Security; Databases; Dose; Elderly; Enrollment; Ensure; Funding; Generations; Goals; Health system; Hospitals; Human; Human Subject Research; Immune response; Immune system; Immunological Models; Immunologics; Immunology; Infection; Influenza; Infrastructure; Investigation; Island; Ixodes; Lyme Disease; Maine; Measures; Participant; Patient Recruitments; Physicians; Preparation; Protocols documentation; Research; Research Design; Research Personnel; Research Project Grants; Resources; Retrieval; Safety; Sampling; Scientist; Services; Shipping; Site; Syndrome; System; Texas; Tick-Borne Diseases; Vaccination; Vaccines; Virus Diseases; West Nile viral infection; West Nile virus; Work; age effect; base; clinical research site; cohort; data management; design; electronic data; experience; frailty; functional status; human subject; human tissue; influenza virus vaccine; meetings; participant enrollment; pathogenic bacteria; pathogenic virus; programs; recruit; response; screening; vaccine response

A Core will be established to support investigations on human subjects in the three research projects. This Clinical Subjects and Recruitment Core will provide a centralized resource for subject recruitment, screening and enrollment. Project 1 will employ a pre-existing network of clinical sites developed by co-PI Bockenstedt in Connecticut, including the Yale-New Haven Health System, and in Portland, Maine and Mansfield, CT for recruitment of participants with Lyme Disease. Project 2 recruitment will be carried out by collaborators in Texas (for West Nile Virus (WNV) infection), but will also include participants in Connecticut with WNV disease. Project 3 will utilize already-collected samples from a previously enrolled cohort; in addition, young (age 21- 30), non-frail and frail older (age ≥70) adults will be enrolled for a study of the high-dose influenza vaccine based in New Haven, Connecticut. This Core will also be responsible for ensure safety and information security for all participants and for compliance with all regulatory measures. The Core will be responsible for maintaining and deploying our established barcoding sample system for generation of subject numbers, tracking of samples, and mapping to external IDs, collaborating with Core B (Data Management and Analysis), where data management platforms are based. The Core is led by investigators with extensive experience carrying out human immunology studies who have the necessary regulatory and clinical experience. Consequently, this Clinical Subjects and Recruitment Core will advance the goals of this Human Immunology Project Consortium application.

将设立一个核心，以支持三个研究项目中有关人类受试者的研究。这 临床受试者和招募核心将为受试者招募、筛选和评估提供集中资源。 和注册。项目1将采用共同PI Bockenstedt在 康涅狄格州，包括耶鲁-纽黑文卫生系统，以及波特兰、缅因州和曼斯菲尔德， 招募患有莱姆病的参与者。项目2的招募工作将由合作者在 德克萨斯州（西尼罗河病毒（WNV）感染），但也将包括康涅狄格州的参与者与WNV疾病。 项目3将利用从先前招募的队列中已经收集的样本;此外，年轻（21- 30岁）的受试者将被纳入研究。 30），非虚弱和虚弱的老年人（年龄≥70）将入组高剂量流感疫苗研究 位于康涅狄格州纽黑文市该核心还将负责确保安全和信息 所有参与者的安全以及遵守所有监管措施。核心将负责 维护和部署我们已建立的条形码样本系统以生成受试者编号， 跟踪样品，并映射到外部ID，与核心B（数据管理和分析）协作， 数据管理平台的基础。核心小组由经验丰富的调查人员领导 开展人体免疫学研究的人员，具有必要的监管和临床经验。 因此，该临床学科和招聘核心将推进该人类免疫学的目标 Project Consortium应用程序。