Clinical Studies Core

临床研究核心

基本信息

批准号：
7645422
负责人：
Raphael Dolin
金额：
$ 55.61万
依托单位：
HARVARD MEDICAL SCHOOL
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-03-01 至 2009-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7645422
关键词：
Address Back Bed Occupancy Beds Bioterrorism Blood specimen Case Study Characteristics Clinical Clinical Investigator Clinical Research Confidentiality Data Collection Disease Experimental Designs Hospitals Human Human Resources Infection Inpatients Investigation Laboratories Laboratory Animal Models Minority Mission Modality Nurses Pathogenesis Patients Phase Prevention Procedures Protocols documentation Quality Control Records Recruitment Activity Research Personnel Research Project Grants Resources Safety Sampling Scientist Secure Services Site Specimen Standards of Weights and Measures Stream Testing Therapeutic Tissues Training Translations Vaccine Clinical Trial Visit Woman Work biodefense design experience feeding healthy volunteer human disease insight investigator training programs protocol development sample collection therapeutic vaccine vaccine development

Address Back Bed Occupancy Beds Bioterrorism Blood specimen Case Study Characteristics Clinical Clinical Investigator Clinical Research Confidentiality Data Collection Disease Experimental Designs Hospitals Human Human Resources Infection Inpatients Investigation Laboratories Laboratory Animal Models Minority Mission Modality Nurses Pathogenesis Patients Phase Prevention Procedures Protocols documentation Quality Control Records Recruitment Activity Research Personnel Research Project Grants Resources Safety Sampling Scientist Secure Services Site Specimen Standards of Weights and Measures Stream Testing Therapeutic Tissues Training Translations Vaccine Clinical Trial Visit Woman Work biodefense design experience feeding healthy volunteer human disease insight investigator training programs protocol development sample collection therapeutic vaccine vaccine development

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项目摘要

The Clinical Studies Core will conduct studies in humans on promising vaccines and therapeutics that emerge from the laboratories of NERCE or from the biodefense related work of other scientists in our region. The Core will collaborate with other investigators in protocol design and will provide a cadre of trained and experienced clinical investigators and support personnel to conduct the studies. Data collection, quality control, and statistical analysis will also be provided. The core will also collect, prepare, preserve, store, and retrieve clinical samples, including specimens of blood, mucosal secretions, and tissues. The Core will maintain a program to recruit a steady flow of subjects with a variety of characteristics, with emphasis on inclusion of women and minorities in the studies. Training of investigators and visiting workers in proper conduct of clinical studies will be offered. The Clinical studies will be conducted primarily in an ambulatory site at Brigham and Women's Hospital which consists of 10 fully equipped examination rooms, and auxiliary space dedicated exclusively to clinical studies. The site will be able to accommodate 150 subjects annually with a total of 1500 visits per year. In patient studies can be performed in the 11 bed GCRC unit at Brigham and Women's Hospital, which can accommodate at least 200 bed days for our studies. It is anticipated that the majority of clinical studies will be of the early "phase I or ir' types, and that all six of the proposed research projects will utilize the Clinical Studies Core. Intensive efforts will be undertaken to make investigators aware of the existence of and services provided by the Core, and to encourage use of its capabilities by investigators both at NERCE and elsewhere in the region.

临床研究核心将对人类进行有希望的疫苗和从Nercer的实验室或生物陷入相关的工作中出现的治疗剂我们地区的其他科学家。核心将与其他调查人员合作协议设计并将提供培训和经验丰富的临床调查人员和支持人员的干部进行研究。还将提供数据收集，质量控制和统计分析。核心还将收集，准备，保存，存储和检索临床样本，包括血液，粘膜分泌物和组织的标本。核心将保持一个计划，以招募各种各样的主题流动特征，重点是将妇女和少数民族纳入研究。培训将提供调查人员和来访者进行适当的临床研究。临床研究将主要在Brigham的门诊和妇女医院由10个设备齐全的检查室和辅助空间组成专门用于临床研究。该网站将能够容纳150个主题每年每年共有1500次访问。在患者研究中可以在11张床中进行 Brigham and妇女医院的GCRC部门，至少可以容纳200天我们的研究。预计大多数临床研究将是早期的“ I或IR类型的早期，并且所有六个拟议的研究项目都将利用临床研究核心。密集的将努力使调查人员了解由核心，并鼓励尼尔和其他地方的调查人员使用其功能该地区。