NINDS Office of the Clinical Director

临床主任办公室(OCD)为NINDS IRP的临床研究提供集中监督和支持，并为在临床中心开展临床研究的所有NIH研究所提供神经学专业知识和咨询。 强迫症通过协调NINDS注册卫生保健提供者的认证过程和能力审查，确保NINDS临床研究方案提供的临床护理质量。质量保证活动包括图表审查、每月随机审计临床研究方案以确保遵守同意程序和医疗文件，以及每月举行临床护理会议以审查并发症、事件和不良事件。每年7月都会为新的临床研究员举行年度培训。OCD的工作人员是临床中心质量保证委员会的积极参与者，向NINDS临床工作人员传达医院政策和实践的变化。 神经病学咨询服务提供24小时/天、7天/周的内部医生咨询。脑电图科和肌电图科提供每个工作日的定期诊断测试，24/7全天候提供紧急脑电波报道。脑电图科还提供术中监测服务，并运营一个活跃的诊断睡眠实验室。其他专科咨询服务，如神经心理测试、儿科神经学咨询、肌肉活组织检查和咨询，可根据需要提供。 NINDS研究人员的所有临床方案都由一名生物统计学家和一个科学审查委员会审查，以确保所进行的研究符合高科学标准。强迫症组织方案审查过程，召集的委员会每月召开会议，并安排特别审查，以提供专业领域的专业知识。NINDS是联合神经科学机构研究委员会管理的牵头机构，该委员会为在NIH开展神经科学研究的六个研究所审查人类学科方案。CNS IRB的工作人员为调查人员提供培训和建议，以引导方案审批过程。OCD提供预算和人员来支持CNS IRB的工作。OCD通过内部和外部委员会和合同，根据需要进行额外的审计和审查。在2009财政年度，强迫症与外间顾问签订合约，检讨资料处理方法，以确保在研究中取得的病人资料的保密性和安全性。 强迫症还为跨越NINDS的多个临床研究计划的共同需求提供支持。提供科学支持的强迫症人员包括生物统计学家，他们为临床方案和数据分析的设计提供建议，以及一名成像科学家，以促进使用磁共振成像的研究人员的工作。临床护理支持可以在有限或短期的基础上提供给研究人员，以扩展他们的项目资源。强迫症还为外部医疗服务提供预算支持，如出于研究目的的基因检测，以及为患者服务，如住宿和参加临床方案的旅行。在2009财年，强迫症进行了一个网站的重组，以招募患者参加NINDS临床方案。 每年9月至6月，强迫症中心每周组织一次NINDS大型巡回演讲会，由内部和外部演讲者参加，并为与会者安排继续医学教育学分。此外，它还协调实习和医学生选修轮换，为来自其他机构的受训人员提供参与临床研究的机会。强迫症还为专职卫生专业人员的教育做出贡献，支持神经科学护理的年度审查课程，并与临床中心合作定期开展神经科学护理实习计划。招募活动在年度神经学会议上举行，并进行邮寄和期刊广告以招募临床研究员。在2009财年，为了促进IRP中新的临床研究人员的发展，设立了亨利·麦克法兰临床过渡到独立奖，这是一个连接临床研究员和新研究员角色的奖项。

The Office of the Clinical Director (OCD) provides centralized oversight and support for conducting clinical research in the NINDS IRP, and provides neurological expertise and consultations for all NIH institutes that carry out clinical research in the Clinical Center. The OCD assures the quality of clinical care provided in NINDS clinical research protocols by coordinating the credentialing process and competency reviews of NINDS licensed health care providers. Quality assurance activities include chart reviews, monthly random audits of clinical research protocols for adherence with consent processes and medical documentation, and a monthly clinical care conference to review complications, occurrences, and adverse events. An annual orientation is held for new clinical fellows each July. The staff of the OCD are active participants in the Clinical Center's Quality Assurance Committee, communicating changes in hospital policies and practices to the NINDS clinical staff. The Neurology Consultation Service provides in-house physician consultations on a 24 hr/day, 7 day/week basis. The EEG Section and EMG section provide scheduled diagnostic testing each weekday, with emergency EEG coverage on a 24/7 basis. The EEG section also provides intraoperative monitoring services, and runs an active diagnostic sleep laboratory. Additional specialty consultative services, such as neuropsychological testing, pediatric neurological consultation, and muscle biopsies and consultations are made available on an as-needed basis. All clinical protocols of NINDS investigators are reviewed by a biostatistician and a scientific review committee to ensure that the research carried out meets high scientific standards. The OCD organizes the protocol review process, with monthly meetings of the convened committee, and ad hoc reviews arranged to provide expertise in specialty areas. The NINDS serves as the lead institute for the administration of the Combined Neuroscience Institutional Research Board, which reviews human subject protocols for six institutes that carry out neuroscience research at NIH. CNS IRB staff provide training and advice to investigators to navigate the protocol approval process. OCD contributes budget and personnel to support the work of the CNS IRB. The OCD carries out additional auditing and reviews on an as-needed basis through internal and external committees and contracts. In FY09, OCD contracted with an outside consultant for a review of the data handling practices to ensure confidentiality and security of patient information obtained in research. The OCD also provides support for common needs that cross multiple clinical research programs of NINDS. OCD personnel who provide scientific support include biostatisticians who advise on the design of clinical protocols and data analysis, and an imaging scientist to facilitate work of investigators using magnetic resonance imaging. Clinical care support may be provided on a limited or short-term basis to investigators to extend their program resources. The OCD also provides budgetary support for outside medical services, such as genetic testing for research purposes, and for patient services such as lodging and travel to participate in clinical protocols. In FY09, OCD undertook the reorganization of a website for recruiting patients to participate in NINDS clinical protocols. The OCD organizes a weekly NINDS Grand Rounds from September to June each year with internal and outside speakers, and arranges continuing medical education credit for attendees. In addition, it coordinates residency and medical student elective rotations, to give trainees from other institutions opportunities to participate in clinical research. The OCD also contributes to the education of allied health professionals, with support of the annual review course for neuroscience nursing, and partnership with the Clinical Center for a periodic neuroscience nursing internship program. Recruitment activities are held at annual neurology meetings, and mailings and journal ads to recruit clinical fellows are carried out. A new initiative in FY09 to foster the development of new clinical investigators in the IRP was the creation of the Henry McFarland Clinical Transition to Independence Award, an award that bridges clinical fellowship and new investigator roles.