课题基金 / 基金详情

CORE--CLINICAL

CORE--CLINICAL
核心--临床
批准号:
6352638
负责人:
Gregory James Mertz
金额:
$10.05万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2000
资助国家:
美国
项目状态:
已结题
起止时间:
2000-09-01 至 2001-08-31

项目摘要

项目成果

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中文摘要
翻译
行政/临床核心将为所有四个ICIDR项目、病毒学核心和Fogarty ABC计划提供行政和基础设施支持。ICIDR主任Mertz博士将在主要外国合作者Vial博士的协助下担任核心领导;首席研究护士/项目经理,以及科罗拉多大学的其他工作人员。Vial博士将在行政上负责智利境内的所有项目,包括该部的项目。Belmar博士将领导卫生部内的一个工作组,以确保该部的每个组成部分(环境、公共卫生研究所、流行病学和每个区域卫生服务)有效地相互作用,以支持研究项目、病毒学核心和福格蒂ABC计划的总体目标。默茨博士还将领导一个高级咨询小组(SAG),为项目、病毒学核心和福格蒂ABC培训计划提供总体指导。将在以下地点建立三个临床研究小组:1)智利圣地亚哥天主教大学医学研究中心;2)科伊海克地区医院和科伊海克第十一区保健服务;3)智利特木科地区医院和智利特木科第九区南部保健服务。每个项目将有一名医师主任和一名研究护士来支持项目2、3和4中描述的临床研究。行政单位应负责患者进入临床研究,填写病例记录表,收集、处理和运送临床样本,以支持项目2、3和4。圣地亚哥医学研究中心的首席研究护士将主要负责数据录入、法规事务、现场监测和质量保证。将建立临床、临床试验、流行病学、啮齿动物、地理信息系统、病毒学和HLA数据集的相关数据库。通过互联网,每个研究小组和福格蒂培训生将能够以电子方式访问由每个研究组成部分维护的数据库,并将有能力访问数据。不同级别的数据访问将由密码控制。Weiss博士将领导一个信息管理咨询小组(IMAG),负责数据库的开发和数据库之间的访问。利用临床数据库,由EVRG项目支持的新墨西哥大学临床数据库,以及CASG和ICIDR治疗研究中安慰剂治疗受试者的数据,Mertz博士和其他人将描述,比较和对比Andes和Sin nombre相关HCPS的临床过程。
英文摘要
The administrative/clinical core will provide administrative and infrastructure support for all four ICIDR projects, for the virology core and for the Fogarty ABC program. Dr. Mertz, the ICIDR Director will serve as core leader, with the assistance of Dr. Vial, the Major Foreign Collaborator; the lead research nurse/program manager, and other staff at CU. Dr. Vial will be administratively responsible for all projects within Chile, including those in the Ministry. Dr. Belmar will lead a workgroup within the Ministry of Health to ensure that each Ministry component (Environment, the Institute of Public Health (ISP), Epidemiology, and each regional health service) interacts effectively to support the overall objectives the research projects, the virology core and the Fogarty ABC program. Dr. Mertz will also lead a senior advisory group (SAG) that will provide overall direction for the projects, the virology core, and the Fogarty ABC training program. Three clinical research groups will be established in 1) the Medical Research Center of Catholic University in Santiago Chile, 2) the Coyhaique Regional Hospital and Region XI Health Service in Coyhaique, and 3) the Temuco Regional Hospital and Region IX, South Health Service in Temuco, Chile. Each will have a physician director and a research nurse to support the clinical research studies described in Projects 2, 3 and 4. The administrative units shall be responsible for entry of patients into clinical studies, completion of case record forms, and collection, processing and shipment of clinical samples in support of projects 2, 3, and 4. Data entry, regulatory affairs, field monitoring and quality assurance will be the primary responsibility of the lead research nurse based with Dr. Vial at the Center for Medical Research in Santiago. Interrelated databases will be established for clinical, clinical trial, epidemiology, rodent, GIS, virology, and HLA data sets. Via the internet each research group and Fogarty trainees will have electronic access to data bases maintained by each research component and will have the ability to access data. Different levels of data access will be controlled by passwords. Dr. Weiss will lead an Information Management Advisory Group (IMAG) that will be responsible for development of the databases and the access between databases. Using the clinical databases, the UNM clinical database supported by the EVRG program, and data from placebo-treated subjects in the CASG and ICIDR treatment studies, Dr. Mertz and others will describe, compare and contrast the clinical course of Andes- and Sin Nombre-associated HCPS.
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海外基金