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：
7734571
负责人：
Darryl C Zeldin
金额：
$ 76.5万
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/7734571
关键词：
Address Area Centrifugation Clinical Clinical Protocols Clinical Research Clinical Services Computer software Core Facility Development Education Educational workshop Electronics Enrollment Ensure Environmental Exposure Evaluation Generations Goals Guidelines Hand Human Human Activities Human Rights Human Subject Research Individual Institutes Institution Investigation Mission Monitor Operative Surgical Procedures Participant Patient Recruitments Patients Phenotype Procedures Process Protocols documentation Regulation Research Research Design Research Ethics Committees Research Personnel Research Project Grants Research Proposals Sampling Scientist Series Services Social Welfare Specimen Staging Standards of Weights and Measures Structure Susceptibility Gene System Testing Training Training Programs Translational Research United States Food and Drug Administration United States National Institutes of Health Utilization Review Work clinical research site cysteine rich protein day design drug testing member programs protocol development quality assurance symposium

项目摘要

During the FY2008 the NIEHS Clinical Research Unit was built and is now in the final stages of completion. The NIEHS Clinical Research Program Team has put together an operational plan delineating research options for the NIEHS, and has presented this plan to the Institute and Program Directors. Furthermore, 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. 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.

在2008财年期间，NIEHS临床研究部门建立了，现在正处于完成的最后阶段。 NIEHS临床研究计划团队已经为NIEHS制定了一项运营计划，并将该计划介绍给了研究所和计划主管。此外，CRP团队在评估临床研究建议的评估中完成了一项标准的操作程序草案，用于科学和利用审查过程。这是为了确保在维持财政审慎的同时确保最高质量的研究。此外，CRP团队与马里兰州贝塞斯达的临床研究中心成员保持着密切的联系，以便使用NIH临床研究的现有框架简化NIEHS临床操作。最后，已经购买了一种临床研究软件，现在正在根据NIEHS调查人员的需求量身定制。 NIEHS临床研究计划已通过人类研究合规办公室（OHRC）的开发在2008财年建立了全面的人类研究保护计划。 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协议，开发和实施标准操作程序，以确保NIEHS符合DHHS，FDA，NIH指南和法规。