UAB International Clinical Research and Management Training Program

描述（申请人提供）：我们的临床培训计划旨在作为国家研究人员和NIAID国际卓越研究中心（ICER）计划，伯明翰亚拉巴马大学（UAB），Fogarty国际中心（FIC），工作人员和国家过敏和传染病研究所（NIAID）合作研究人员之间的合作努力，以及位于马里巴马科、印度金奈和乌干达坎帕拉或附近的ICER研究中心合作者。该倡议的目的是通过合作培训和研究，加强和维持NIAID资助的科学家，医生，护士和公共卫生从业人员为临床研究做出贡献的能力。为此，我们设计了一个培训计划，该计划将使NIAID资助的实地研究人员和主要工作人员做好准备，以解决与国际合作背景下国际临床传染病（ID）研究的开展和管理有关的所有关键问题。此外，我们打算让他们做好充分参与研究的准备，以解决预防和控制传染病的全球问题，强调当地的研究目标领域。我们的培训计划是多学科的，将包括临床研究设计，流行病学，健康行为，生物统计学，卫生政策，临床试验监管机制，研究伦理，数据管理，现场管理，临床管理，推广和保留，临床和实验室事务的质量保证，以及观察，治疗和预防研究的关键原则。我们相信UAB是ICER的理想大学合作伙伴，原因有很多，其中包括：（1）我们的人员在非洲，亚洲，南美和北美以及欧洲的临床研究中有良好的记录;（2）我们的培训计划将有效地建立在UAB相关活动和机构的基础上，包括六个非常成功的国际研究培训计划。我们打算首先评估ICER研究中心对研究者、研究经理、管理人员、实验室主任和关键工作人员的临床研究和管理培训需求，首先考虑现场和区域培训，如果效率更高，则在美国进行培训。根据需求评估的结果，制定并实施临床研究培训活动课程，以加强ICER和其他NIAID和FIC支持的国际研究中心的研究人员进行临床ID研究和有效管理ID研究计划和项目的能力。该培训课程旨在通过提供侧重于临床研究能力建设的培训内容，将ICER研究中心建设成为临床研究的区域卓越中心。

DESCRIPTION (provided by applicant): Our clinical training program is designed as a collaborative effort between in-country investigators and staff at the NIAID International Centers of Excellence in Research (ICER) Program, the University of Alabama at Birmingham (UAB), the Fogarty International Center (FIC), staff and collaborating investigators from the National Institute of Allergy and Infectious Diseases (NIAID), and ICER site collaborators in or near Bamako, Mali; Chennai, India; and Kampala, Uganda. The purpose of this initiative is to strengthen and sustain, through collaborative training and research, the ability of NIAID-funded scientists, physicians, nurses, and public health practitioners to contribute to clinical research. To this effect we have designed a training program that will prepare NIAID-funded field researchers and key staff to address all the key issues pertaining to the conduct and management of international clinical infectious disease (ID) research in the context of international collaboration. In addition, we intend to prepare them to participate fully in research addressing global problems in ID prevention and control, emphasizing local research target areas. Our training program is multidisciplinary and will include clinical research design, epidemiology, health behavior, biostatistics, health policy, clinical trial regulatory mechanisms, research ethics, data management, field management, clinical management, outreach and retention, quality assurance in clinical and laboratory matters, and key principles in observational, treatment and prevention research. We believe that UAB is an ideal university partner for the ICER for many reasons, among them: (1) our personnel have proven track records in clinical research in Africa, Asia, South and North America, and Europe; (2) our training initiatives will build efficiently on UAB-linked activities and institutions, including six highly successful FIC-funded international research training initiatives. We intend to first assess clinical research and management training needs at ICER sites for investigators, research managers, administrators, laboratory directors, and key staff, considering on-site and regional training first, and when more efficient, training in the United States. Based on the results of the needs assessment, develop and implement a curriculum of clinical research training activities that will strengthen the capacity of investigators at ICER and other NIAID- and FIC-supported international sites to conduct clinical ID research and effectively manage ID research programs and projects. This training curricula will aim at building the ICER sites into regional centers of excellence in clinical research by providing training components that focus on capacity building for clinical research.