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: 8336719
• 负责人: Darryl C Zeldin
• 金额: $ 413.64万
• 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/8336719
• 关键词: Address; Area; Asthma; Cardiovascular Diseases; Centrifugation; Clinical; Clinical Protocols; Clinical Research; Clinical Services; Collaborations; Computer software; Core Facility; Development; Education; Educational workshop; Electronics; Enrollment; Ensure; Environmental Exposure; Ethics; Evaluation; Generations; Goals; Guidelines; Human; Human Rights; Human Subject Research; Individual; Institutes; Institution; Institutional Review Boards; Investigation; Malignant Neoplasms; Metabolic Diseases; Mission; Monitor; National Institute of Environmental Health Sciences; Participant; Patient Recruitments; Patients; Phenotype; Procedures; Process; Protocols documentation; Recruitment Activity; Regulation; Research; Research Design; Research Personnel; Research Project Grants; Research Proposals; Rights; Sampling; Scientist; Series; Services; Social Welfare; Specimen; Structure; Suggestion; Susceptibility Gene; System; Testing; Training; Training Programs; Translational Research; United States National Institutes of Health; Universities; Utilization Review; Work; clinical research site; design; drug testing; member; operation; programs; protocol development; quality assurance; symposium; web site

The NIEHS Clinical Research Program Team has put together an operational plan delineating research options for the NIEHS, presented this plan to the Institute and Program Directors, and received approval for operations. The new NIEHS Clinical Research Unit (CRU) was inaugurated in July 2009. Initial staff has been hired and has implemented a set of standard operating procedures for CRU function. The CRU was audited by high-level NIH Clinical Center Representatives and their suggestions have been incorporated into the CRU operations. The CRP Team has completed a standard operational procedure draft for scientific and utilization review processes in the evaluation of clinical research proposals. This is meant to ensure highest quality research while maintaining fiscal prudence. Furthermore, the CRP Team has been in close contact with members of the Clinical Research Center in Bethesda, MD, in an effort to streamline NIEHS clinical operations with the pre-existing framework of NIH Clinical Research. Finally, a clinical research software has been purchased and is now being tailored to the needs of NIEHS investigators. With this operational background in place, several studies have been proposed by CRU staff in collaboration with NIEHS investigators, involving the fields of cancer, asthma, metabolic disease and cardiovascular disease. Patients have been already recruited for some of these studies. Furthermore, collaboration avenues with local universities as well as other governmental agencies are currently being pursued. The NIEHS Program in Clinical Research has established a comprehensive Human Research Protection Program within the FY2008 thru the development of the Office of Human Research Compliance (OHRC). This office will be 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, stregthening 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 operationanl procedures,to ensure that NIEHS complies with DHHS, FDA, NIH guidlines and regulations.

NIEHS 临床研究项目团队制定了一份运营计划，描述了 NIEHS 的研究选项，将该计划提交给研究所和项目主任，并获得运营批准。 新的 NIEHS 临床研究中心 (CRU) 于 2009 年 7 月成立。最初的工作人员已被聘用，并已针对 CRU 职能实施了一套标准操作程序。 CRU 接受了 NIH 临床中心高级代表的审核，他们的建议已纳入 CRU 运营中。 CRP 团队已经完成了临床研究提案评估中科学和利用审查流程的标准操作程序草案。这是为了确保最高质量的研究，同时保持财政审慎。 此外，CRP 团队一直与马里兰州贝塞斯达临床研究中心的成员保持密切联系，努力利用 NIH 临床研究现有框架简化 NIEHS 临床操作。 最后，我们购买了临床研究软件，目前正在根据 NIEHS 研究人员的需求进行定制。 有了这样的运作背景，CRU 工作人员与 NIEHS 研究人员合作提出了几项研究，涉及癌症、哮喘、代谢疾病和心血管疾病领域。 其中一些研究已经招募患者。 此外，目前正在寻求与当地大学以及其他政府机构的合作途径。 NIEHS 临床研究计划通过人类研究合规办公室 (OHRC) 的发展，在 2008 财年建立了全面的人类研究保护计划。 该办公室将负责管理和协调 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，执行质量临床场所的保证/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及其员工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。