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

• 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
• 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

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11，000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。 此外，本集团已开展新的研究工作，以应对COVID-19疫情的影响以及与环境风险的相互作用。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。 本项目涉及人类冠状病毒、新型冠状病毒、COVID-19、严重急性呼吸综合征冠状病毒病、SARS冠状病毒、SARS-coronavirus-2、SARS-cov-2、SARS-cov 2、SARS-related coronavirus 2、严重急性呼吸综合征冠状病毒2、SARS-Associated Coronavirus、SARS-cov或SARS-related Coronavirus的研究。