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：
10252620
负责人：
Janet Hall
金额：
$ 513.74万
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/10252620
关键词：
2019-nCoV Address Area Asthma Autoimmunity Back COVID-19 COVID-19 pandemic 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 Endothelium 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 Institutional Review Boards 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 SARS coronavirus Sampling Scientist Series Services Severe Acute Respiratory Syndrome 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 human coronavirus injury and repair novel coronavirus operation programs protocol development quality assurance receptor symposium tenure track translational scientist translational study web site welfare

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 11,000 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. In addition, new research efforts have been developed to address the impact of COVID-19 pandemic and interactions with environmental exposures. 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. This project involves research on human coronavirus, novel coronavirus, COVID-19, Severe Acute Respiratory Syndrome coronavirus disease, SARS coronavirus, SARS-coronavirus-2, SARS-cov-2, SARS-cov2, SARS-related coronavirus 2, Severe acute respiratory syndrome coronavirus 2, SARS-Associated Coronavirus, SARS-cov, or SARS-Related Coronavirus.

NIEHS 临床研究分部不断扩大对临床和转化研究的支持范围。 NIEHS 临床研究中心 (CRU) 记录了 11,000 多次患者就诊，患者满意度超过 95%。已聘请更多员工来支持 CRU 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 Bethesda CC，并与贝塞斯达的 NIEHS 环境自身免疫小组合作。 CRU 目前正在进行研究，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等领域。此外，还开展了新的研究工作来解决 COVID-19 大流行的影响以及与环境暴露的相互作用。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，包含超过 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相关的后续研究涉及炎症、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，与当地大学以及其他政府机构的合作途径目前正在进行中。 NIEHS 临床研究分部通过人类研究合规办公室 (OHRC) 的发展，建立了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 的日常行政运作，开发和维护支持 OHRC 活动的电子管理系统和网站，执行质量保证/临床站点的质量改进审核，加强和提高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类研究协议，制定和实施标准操作程序，以确保NIEHS遵守DHHS、FDA、NIH 指南和法规。该项目涉及人类冠状病毒、新型冠状病毒、COVID-19、严重急性呼吸系统综合症冠状病毒病、SARS冠状病毒、SARS-coronavirus-2、SARS-cov-2、SARS-cov2、SARS相关冠状病毒2、严重急性呼吸道疾病的研究综合征冠状病毒 2、SARS 相关冠状病毒、SARS-cov 或 SARS 相关冠状病毒。