权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Program in Clinical Research, Clinical Support Services and Clinical Training

临床研究、临床支持服务和临床培训项目

基本信息

批准号：
9550665
负责人：
Stavros Garantziotis
金额：
$ 393.36万
依托单位：
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9550665
关键词：
Address Area Asthma Autoimmunity Back Cardiovascular Diseases Centrifugation Client satisfaction Clinical Clinical Protocols Clinical Research Clinical Trials Database Collaborations Core Facility DNA DNA Damage Development Drug Kinetics Education Educational workshop Electronic Health Record Endocrine Enrollment Ensure Environmental Exposure Ethics Follow-Up Studies Generations Genetic Polymorphism Goals Government Agencies Guidelines Human Human Rights Human Subject Research Immunology Individual Inflammation Institutes Institution Investigation Lung diseases Malignant Neoplasms Metabolic Diseases Mission Monitor National Institute of Environmental Health Sciences Neuroendocrinology North Carolina Nursing Research Participant Patient Recruitments Patients Phenotype Procedures Protocols documentation Registries Regulation Research Research Design Research Personnel Research Project Grants Sampling Scientist Series Services Social Welfare Specimen Structure Susceptibility Gene System Testing Time Training Training Programs Training and Education Translational Research United States National Institutes of Health Universities clinical research site cohort drug testing injury and repair operation programs protocol development quality assurance receptor symposium tenure track translational scientist translational study web site

项目摘要

The NIEHS Clinical Research Branch has continued to expand its scope of support for clinical and translational studies. The NIEHS Clinical Research Unit (CRU) has recorded over 8000 patient encounters with over 95% patient satisfaction. Additional staff have been hired to support CRU functions. The NIEHS' CRU is integrated into the Bethesda CC via the CRIS electronic health record system and the Clinical Trials Database, and collaborated with the NIEHS Environmental Autoimmunity Group in Bethesda. Studies are currently underway at the CRU, involving the fields of asthma, cancer, cardiovascular disease, immunology, inflammation, metabolic disease, neuroendocrinology, and pharmacokinetics. Many studies take advantage of the Environmental Polymorphisms Registry (EPR), a NIEHS-operated cohort encompassing over 15,000 North Carolina residents, who have donated DNA and have agreed to be called back for phenotypic studies. EPR-related follow-up studies address issues of inflammation, DNA injury repair, endocrine receptor polymorphisms, endothelial function and lung disease. Furthermore, collaboration avenues with local universities as well as other governmental agencies are currently underway. The NIEHS Clinical Research Branch has established a comprehensive Human Research Protection Program thru the development of the Office of Human Research Compliance (OHRC). This office is responsible for managing and coordinating the pre-IRB clinical and scientific review of NIEHS clinical studies, supporting the day to day administrative operations of the IRB, Developing and maintaining electronic management systems and websites that support activities of the OHRC, Performing quality assurance/quality improvement audits of clinical sites, strengthening and enhancing the human research protection education and training program, working with scientific / clinical PIs and their staff to develop human research protocols, developing and implementing standard operational procedures, to ensure that NIEHS complies with DHHS, FDA, NIH guidelines and regulations.

NIEHS临床研究分支继续扩大其对临床和转化研究的支持范围。 NIEHS临床研究单位（CRU）记录了超过8000例患者，患者满意度超过95%。已雇用额外的工作人员来支持CRU的职能。 NIEHS的CRU通过CRIS电子健康记录系统和临床试验数据库集成到贝塞斯达CC中，并与贝塞斯达的NIEHS环境自身免疫组合作。研究目前正在CRU进行，涉及哮喘，癌症，心血管疾病，免疫学，炎症，代谢疾病，神经内分泌学和药代动力学领域。许多研究利用了环境多态性登记处（EPR），这是一个由NIEHS运营的队列，包括超过15，000名北卡罗来纳州居民，他们捐献了DNA并同意被召回进行表型研究。 EPR相关的随访研究涉及炎症、DNA损伤修复、内分泌受体多态性、内皮功能和肺部疾病等问题。此外，目前正在与当地大学以及其他政府机构开展合作。NIEHS临床研究分支通过人类研究合规办公室（OHRC）的发展建立了一个全面的人类研究保护计划。该办公室负责管理和协调NIEHS临床研究的IRB前临床和科学审查，支持IRB的日常行政操作，开发和维护支持OHRC活动的电子管理系统和网站，对临床研究中心进行质量保证/质量改进稽查，加强和改进人类研究保护教育和培训计划，与科学/临床PI及其工作人员合作，制定人体研究方案，制定和实施标准操作程序，以确保NIEHS符合DHHS，FDA，NIH指南和法规。