Core D: Clinical Recruitment

核心 D：临床招募

基本信息

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
项目类别：
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

项目摘要

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.

将建立一个核心来支持这三个研究项目中对人类受试者的调查。临床受试者和招募核心将为受试者招募、筛选提供集中资源项目 1 将采用由联合 PI Bockenstedt 开发的现有临床站点网络。康涅狄格州，包括耶鲁-纽黑文卫生系统，以及缅因州波特兰和康涅狄格州曼斯菲尔德莱姆病参与者的招募项目 2 的招募将由以下国家的合作者进行。德克萨斯州（针对西尼罗河病毒 (WNV) 感染），但也将包括康涅狄格州患有西尼罗河病毒 (WNV) 疾病的参与者。项目 3 将利用之前登记的队列中已收集的样本，其中包括年轻人（21 岁以下）； 30），非体弱和体弱老年人（年龄≥70岁）将被纳入高剂量流感疫苗研究该核心总部位于康涅狄格州纽黑文，还将负责确保安全和信息。核心将负责所有参与者的安全以及遵守所有监管措施。维护和部署我们已建立的条形码样本系统以生成主题编号，与核心 B（数据管理和分析）合作，跟踪样本并映射到外部 ID， The Core 由具有丰富经验的调查人员领导。具有必要的监管和临床经验的进行人类免疫学研究的人员。审查后，该临床受试者和招募核心将推进该人类免疫学的目标项目联合体申请。