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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：
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
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/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

项目摘要

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NIEHS的操作计划，描述了NIEHS的研究选择，并将该计划提交给研究所和项目主管，并获得了操作批准。新的NIEHS临床研究单位（CRU）于2009年7月成立。最初的工作人员已被雇用，并已实施了一套标准操作程序的CRU职能。CRU由美国国立卫生研究院临床中心高级代表审核，他们的建议已被纳入CRU的运作。CRP小组已经完成了一份标准操作程序草案，用于评估临床研究建议的科学和利用审查过程。这意味着在保持财政审慎的同时，确保最高质量的研究。此外，CRP小组一直与马里兰州Bethesda临床研究中心的成员保持密切联系，努力在NIH临床研究的现有框架下简化NIEHS的临床操作。最后，已经购买了临床研究软件，现在正在根据NIEHS研究人员的需要进行定制。有了这一业务背景，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、代谢性疾病和心血管疾病等领域。其中一些研究已经招募了患者。此外，目前正在寻求与当地大学和其他政府机构的合作途径。NIEHS临床研究项目通过人类研究合规办公室（OHRC）的发展，在2008财年建立了一个全面的人类研究保护计划。该办公室将负责管理和协调NIEHS临床研究的预IRB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，执行临床站点的质量保证/质量改进审计，加强和加强人体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体研究协议，制定和实施标准操作程序，以确保NIEHS符合DHHS， FDA， NIH的指导方针和法规。