Program in Clinical Research, Clinical Support Services and Clinical Training

NIEHS临床研究项目团队已经制定了一项操作计划，描述了NIEHS的研究选项，并将该计划提交给研究所和项目负责人，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。 最初的工作人员已经聘用，并已实施了一套标准的CRU职能操作程序。 CRU由NIH临床中心高级代表进行稽查，他们的建议已纳入CRU的运营中。 CRP团队已经完成了临床研究提案评估中科学和利用审查过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临床研究的现有框架简化NIEHS临床操作。 最后，已经购买了一个临床研究软件，目前正在根据NIEHS研究人员的需要进行调整。 有了这种操作背景，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了患者。 此外，目前正在寻求与当地大学和其他政府机构合作的途径。 NIEHS临床研究计划通过人类研究合规办公室（OHRC）的发展，在2008财年内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，加强和加强人类研究保护教育和培训计划，与科学/临床PI及其工作人员一起制定人体研究方案，制定和实施标准操作程序，以确保NIEHS符合DHHS，FDA，NIH的指导方针和法规。

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.