Clinical Studies Core

临床研究核心将在人类中对有希望的疫苗进行研究， 来自NERCE实验室或来自生物防御相关工作的治疗方法 我们地区的科学家。核心研究人员将与其他研究者合作进行方案设计 并将提供一支训练有素、经验丰富的临床研究人员和支持人员队伍， 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、制备、保存、储存和检索临床样本，包括 血液、粘膜分泌物和组织标本。 核心将维持一个计划，以招募具有各种 研究的重点是将妇女和少数民族纳入研究。培训 提供研究员和访问人员，以适当进行临床研究。 临床研究将主要在Brigham的门诊研究中心进行， 妇女医院，包括10个设备齐全的检查室和辅助空间 专门用于临床研究。该研究中心将能够容纳150名受试者 每年接待1500人次。在病人的研究可以在11床进行 布里格姆妇女医院的GCRC单位，可容纳至少200个床位日， 我们的研究 预计大多数临床研究将是早期的"I期或IR"类型， 所有六个拟议的研究项目将利用临床研究核心。密集 将作出努力，使调查人员了解是否存在和提供的服务， 核心，并鼓励研究人员在NERCE和其他地方使用其能力， 本地区

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.