Clinical Studies Core

临床研究核心将在人体上进行有希望的疫苗和 NERCE实验室或生物防御相关工作中出现的治疗学 我们地区的其他科学家。核心将在协议设计方面与其他调查人员合作 并将提供一支训练有素、经验丰富的临床研究人员和支助人员队伍，以 进行研究。还将提供数据收集、质量控制和统计分析。 该核心还将收集、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样本。 核心将维持一项计划，以招募稳定的学科流与各种 在这方面，特别强调将妇女和少数群体纳入研究的特点。培训 将提供适当进行临床研究的调查人员和访问工作人员。 临床研究将主要在Brigham和 妇女医院，由10个设备齐全的检查室和辅助空间组成 专门致力于临床研究。该网站将能够容纳150名受试者 每年总访问量为1500人次。患者研究可以在11个床位进行 布里格姆妇女医院的GCRC病房，可容纳至少200个床位日 我们的学习。 预计大多数临床研究将是早期的“I期或I期”类型， 所有六个拟议的研究项目都将利用临床研究核心。集约化 将努力使调查人员了解该组织的存在和提供的服务 核心，并鼓励NERCE和其他地方的调查人员使用其能力 该地区。

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.