NINDS Office of the Clinical Director

NINDS 临床主任办公室

• 批准号: 10708660
• 负责人: Avindra Nath
• 金额: $ 1777.93万
• 依托单位: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
• 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/10708660
• 关键词: Accreditation; Adherence; Adverse event; Appointment; Area; Award; Biopsy; Budgets; Career Transition Award; Caring; Childhood; Clinic; Clinical; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Unit; Collaborations; Competence; Conduct Clinical Trials; Consent; Consult; Consultations; Contracts; Credentialing; Data Analyses; Development; Devices; Diagnostic tests; Documentation; Educational Activities; Electroencephalography; Emergency Situation; Ensure; Epilepsy; Ethics; Fellowship; Foundations; Funding; Future; Goals; Good Clinical Practice; Grant; Health; Health Personnel; Hospitals; Howard Temin Award; Human Resources; Institutes; Institution; Internships; Intramural Research Program; Intraoperative Monitoring; Investigation; Investigational Drugs; Journals; Magnetic Resonance Imaging; Medical; Medical Students; Mission; Monitor; Morbidity - disease rate; Muscle; National Institute of Neurological Disorders and Stroke; Neurodegenerative Disorders; Neurologic; Neurological Nursing; Neurology; Neuropsychological Tests; Neurosciences; Neurosciences Research; Nursing Faculty; Nursing Staff; Online Systems; Parkinson Disease; Participant; Patient Care; Patients; Pediatric Neurology; Periodicity; Physicians; Policies; Principal Investigator; Process; Professional Organizations; Protocols documentation; Recruitment Activity; Research; Research Methodology; Research Personnel; Research Training; Residencies; Resource Sharing; Resources; Review Committee; Role; Rotation; Safety; Schedule; Services; System; Training; Training Programs; Travel; United States National Institutes of Health; University Hospitals; Work; allied health education; clinical care; clinical center; clinical practice; continuing medical education; design; early phase clinical trial; experience; high standard; human subject; human subject protection; imaging scientist; individual patient; inter-institutional; medical specialties; meetings; mortality; multidisciplinary; nervous system disorder; neuroAIDS; neuroimmunology; patient safety; profession allied to medicine; programs; prospective; protocol development; quality assurance; recruit; sound; symposium; training opportunity

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 also focuses on the Fellowship training program developing academic leaders in neurology. 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 meeting 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. Additionally a Clinical Practice Committee was formed in FY16 to oversee the quality of patient care and patient safety. The committee reviews SAEs, occurrences as well as implements projects/policies as necessary to ensure the safety and care of all human subjects. A monthly morbidity and mortality conference is also held to to review individual patients as needed. The OCD acts as the Sponsor for most IND initiated clinical trial at NINDS. The Neurology Consultation Service provides in-house physician consultations on a 24 hr/day, 7 day/week basis. This includes a specialized pediatric neurology consult unit. Consultation rounds are held on Thursdays where all patients seen in the prior week are reviewed. The EEG and EMG Sections provide scheduled diagnostic testing each weekday, with emergency EEG coverage on a 24/7 basis. The EEG Section also provides intra-operative monitoring services. Additional specialty consultative services, such as neuropsychological testing, pediatric neurological consultation, and muscle biopsies and consultations are made available on an as-needed basis. The OCD supports a Clinical Trials Unit which offers assistance to investigators in developing protocols and conducting clinical trial studies. 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 OCD carries out additional auditing and reviews on an as-needed basis through internal and external committees and contracts. The OCD supports the formation and training of a monitoring committee to provide external monitoring of clinical protocols with investigational new drugs (INDs) or devices (IDEs). The OCD also supports Good Clinical Practice Training for Principal Investigators (PIs) with protocols with INDs or IDEs. Investigators upload all protocols into an online system called the Protocol Management Tracking System (PTMS) which provides templates, forms and guides. OCD oversees the PTMS Steering Committee which manages the PTMS budget and the priority of pending task orders. Additionally, the OCD has established a contract with SAIC to support investigators with the development of protocols that require FDA approval for early-phase clinical trials. 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 and for patient services such as lodging and travel to participate in clinical protocols. OCD also supports a bi-annual retreat for NINDS clinical faculty where clinical policies and training are reviewed and discussed for implementation. Alternating with the NINDS clinical faculty retreat, the OCD supports a larger scale bi-annual neurology retreat NIH-wide with participation from multiple institutes to facilitate collaboration and resource sharing. The OCD also supports multidisciplinary inter-institutional clinics, including the Parkinson's Disease Clinic, the Epilepsy Clinic, the Neuroimmunology Clinic, the Neuro-HIV Clinic and the Neurodegenerative diseases clinic. The OCD organizes a weekly Clinical Neuroscience Grand Rounds from September to June each year with internal and outside speakers, and arranges continuing medical education credit for attendees. The grand rounds has a case presentation by one of the clinical Fellows followed by a scientific presentation by an invited speaker. 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 national neurology professional society meetings, and mailings and journal ads to recruit clinical fellows are carried out. In addition, the OCD sponsors an annual Fellowship Recruitment Retreat to attract prospective fellows from around the U.S. during which the NIH and NINDS are showcased. The OCD also established and supports a unique residency program with MedStar Georgetown University Hospital. The educational partnership between the NINDS/NIH and the ACGME-accredited neurology residency program at Georgetown, allows residents an opportunity to develop a strong foundation in research methodology and human subject investigation, thus creating a unique clinical experience and research training opportunity that will develop future leaders in neuroscience research. The OCD also offers a K22 Career Transition Award, to support clinical fellows in the intramural research program. More information about the award can be found at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-282.html. The OCD also provides a travel award for junior trainees who conduct clinical research. Additionally, the OCD also supports the development of new clinical investigators in the IRP with the Henry McFarland Clinical Transition to Independence Award via a Clinical Assistant Investigator (ACI) appointment. This is an award that bridges clinical fellowship and new investigator roles. The OCD has a Fellowship Committee that reviews and recommends funding clinical fellows using OCD funds. The OCD manages the search committees for recruitment of staff clinicians, Nursing staff, ACIs and other clinical staff as needed.

临床主任办公室（OCD）提供了集中的监督，并支持在Ninds IRP进行临床研究，并为所有在临床中心进行临床研究的NIH机构提供神经学专业知识和咨询。强迫症还专注于培养神经病学学术领导者的奖学金培训计划。 OCD通过协调NINDS许可的医疗保健提供者的证书过程和能力审查，确保NINDS临床研究方案中提供的临床护理质量。质量保证活动包括图表审查，通过同意程序和医疗文档遵守临床研究方案的每月随机审核，以及每月一次的临床护理会议，以审查并发症，事件和不良事件。每年七月将举行年度临床研究员的年度介绍。强迫症的工作人员是临床中心质量保证委员会的积极参与者，将医院政策和实践的变化与NINDS临床人员传达。此外，在2016财年成立了一个临床实践委员会，以监督患者护理和患者安全的质量。委员会审查SAE，事件以及必要的项目/政策，以确保所有人类受试者的安全和照顾。还举行了每月的发病率和死亡率会议，以根据需要审查个别患者。强迫症是Ninds大多数IND启动临床试验的赞助商。 神经病学咨询服务以24小时/天，7天/周的基础提供内部医师咨询。这包括专门的儿科神经病学咨询单位。咨询回合在星期四举行，审查了上一周中看到的所有患者。脑电图和EMG部分在每个工作日提供计划的诊断测试，紧急脑电图覆盖范围为24/7。脑电图部分还提供术中监测服务。其他专业咨询服务，例如神经心理学测试，儿科神经学咨询以及肌肉活检和咨询，并在需要的基础上提供。 OCD支持一个临床试验单元，该单元为研究人员提供协助的协议和进行临床试验研究。 Biostatisticians和一个科学审查委员会审查了NINDS研究人员的所有临床协议，以确保进行研究符合高级科学标准。强迫症组织协议审核过程，并举行召集委员会的每月会议，并安排了在专业领域提供专业知识的临时审查。 强迫症通过内部和外部委员会和合同进行了其他审核和审查。强迫症支持监测委员会的形成和培训，以提供对临床方案的外部监测，并使用研究性新药物（IND）或设备（IDES）提供。强迫症还支持具有IND或IDES协议的首席研究人员（PIS）的良好临床实践培训。调查人员将所有协议上传到一个称为协议管理跟踪系统（PTMS）的在线系统，该系统提供模板，表单和指南。 OCD负责监督PTMS指导委员会，该指导委员会管理PTMS预算和未决任务订单的优先级。此外，OCD已与SAIC建立了一份合同，以开发需要FDA批准进行早期临床试验的协议的开发。 OCD还提供了跨越NIND临床研究计划的共同需求的支持。提供科学支持的强迫症人员包括有关临床方案和数据分析设计建议的生物统计学家，以及一名成像科学家，以使用磁共振成像来促进研究人员的工作。可以在有限或短期内向调查人员提供临床护理支持，以扩大其计划资源。强迫症还为外部医疗服务以及住宿和旅行以参与临床方案提供预算支持。 OCD还为NINDS临床教师提供了两年一次的务虚会，在该教师中审查并讨论了临床政策和培训以进行实施。与Ninds临床教师务虚会交替，OCD支持大规模的两年一次的神经病学务虚会，并从多家机构参与了多个机构，以促进协作和资源共享。 OCD还支持多学科的跨机构诊所，包括帕金森氏病诊所，癫痫诊所，神经免疫学诊所，神经HIV诊所和神经退行性疾病诊所。 OCD每年9月至6月每周与内部和外部发言人组织每周一次的临床神经科学大巡回赛，并为与会者安排继续医学教育学分。大回合有一位临床研究员的案例演讲，随后是受邀发言人的科学演讲。此外，它协调居住和医学学生的选修课，以使其他机构的受训者有机会参加临床研究。强迫症还支持盟国卫生专业人员的教育，并在神经科学护理的年度审查课程中，并与定期神经科学护理实习计划的临床中心合作。 招聘活动在年度国家神经病学专业协会会议上举行，并进行了邮寄和期刊广告，以招募临床研究员。此外，OCD还赞助了年度奖学金招聘务虚会，以吸引来自美国各地的潜在研究员，在此期间展示了NIH和NINDS。 OCD还建立了Medstar Georgetown University Hospital的独特居住计划。 NINDS/NIH与乔治敦（Georgetown）的ACGME认可的神经病学住院医师计划之间的教育伙伴关系使居民有机会在研究方法论和人类学科研究中建立强大的基础，从而创造独特的临床经验和研究培训机会，从而开发神经科学研究未来的领导者。 OCD还提供了K22职业过渡奖，以支持壁内研究计划中的临床研究员。有关该奖项的更多信息，请访问：http：//grants.nih.gov/grants/guide/pa-files/par-14-282.html。 OCD还为进行临床研究的初级学员提供了旅行奖。 此外，OCD还通过临床助理研究员（ACI）任命，通过亨利·麦克法兰（Henry McFarland）过渡到独立奖，支持IRP中新的临床研究人员的发展。这是一个奖励临床奖学金和新调查员角色的奖项。强迫症有一个奖学金委员会，该委员会审查并建议使用OCD基金资助临床研究员。强迫症管理搜索委员会，根据需要招募员工临床医生，护理人员，ACI和其他临床人员。