NINDS Office of the Clinical Director

NINDS 临床主任办公室

• 批准号: 10473624
• 负责人: Avindra Nath
• 金额: $ 2476.76万
• 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/10473624
• 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) 为 NINDS IRP 中开展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 机构提供神经学专业知识和咨询。 OCD 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认证流程和能力审查，确保 NINDS 临床研究方案中提供的临床护理的质量。质量保证活动包括图表审查、每月随机审核临床研究方案以遵守知情同意程序和医疗文件，以及每月召开临床护理会议以审查并发症、发生情况和不良事件。每年七月都会为新临床研究员举办年度入职培训。 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。此外，2016 财年还成立了临床实践委员会，负责监督患者护理的质量和患者安全。该委员会审查严重不良事件、事件并根据需要实施项目/政策，以确保所有人类受试者的安全和护理。每月还举行一次发病率和死亡率会议，根据需要审查个别患者。 OCD 是在 NINDS 发起的大多数 IND 临床试验的申办者。 神经病学咨询服务每周 7 天、每天 24 小时提供内部医生咨询。这包括专门的儿科神经病学咨询单位。每周四进行咨询，对前一周见过的所有患者进行审查。脑电图和肌电图部分每周提供定期诊断测试，并提供 24/7 的紧急脑电图覆盖。脑电图科还提供术中监测服务。根据需要提供其他专业咨询服务，例如神经心理学测试、儿科神经学咨询、肌肉活检和咨询。 OCD 支持临床试验部门，该部门为研究人员制定方案和开展临床试验研究提供帮助。 NINDS 研究人员的所有临床方案均由生物统计学家和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。 OCD 组织方案审查流程，每月召开委员会会议，并安排临时审查以提供专业领域的专业知识。 OCD 根据需要通过内部和外部委员会和合同进行额外的审计和审查。 OCD 支持监测委员会的组建和培训，以对研究性新药 (IND) 或设备 (IDE) 的临床方案进行外部监测。 OCD 还通过 IND 或 IDE 协议支持主要研究者 (PI) 的良好临床实践培训。研究人员将所有协议上传到名为协议管理跟踪系统 (PTMS) 的在线系统中，该系统提供模板、表格和指南。 OCD 负责监督 PTMS 指导委员会，该委员会管理 PTMS 预算和待处理任务订单的优先级。此外，OCD 还与 SAIC 签订了一份合同，以支持研究人员制定需要 FDA 批准进行早期临床试验的方案。 OCD 还为 NINDS 多个临床研究项目的共同需求提供支持。提供科学支持的 OCD 人员包括为临床方案设计和数据分析提供建议的生物统计学家，以及利用磁共振成像促进研究人员工作的成像科学家。可以向研究人员提供有限或短期的临床护理支持，以扩展他们的计划资源。 OCD 还为外部医疗服务和患者服务（例如参加临床方案的住宿和旅行）提供预算支持。 OCD 还支持 NINDS 临床教员每年两次的静修会，审查和讨论临床政策和培训以供实施。与 NINDS 临床教员务虚会交替进行，OCD 支持在 NIH 范围内开展更大规模的两年一次的神经病学务虚会，并有多个机构参与，以促进合作和资源共享。 OCD 还支持多学科跨机构诊所，包括帕金森病诊所、癫痫诊所、神经免疫学诊所、神经艾滋病毒诊所和神经退行性疾病诊所。 OCD 每年 9 月至 6 月每周组织一次由内部和外部演讲者参加的临床神经科学大查房活动，并为与会者安排继续医学教育学分。大型回合由一名临床研究员进行案例介绍，随后由受邀演讲者进行科学介绍。此外，它还协调住院医师和医学生选修轮换，为其他机构的学员提供参与临床研究的机会。 OCD 还为专职医疗专业人员的教育做出了贡献，支持神经科学护理年度复习课程，并与临床中心合作开展定期神经科学护理实习计划。 每年的全国神经病学专业协会会议上都会举办招募活动，并通过邮寄和期刊广告来招募临床研究员。此外，OCD 还赞助一年一度的研究员招募静修会，以吸引来自美国各地的潜在研究员，期间将展示 NIH 和 NINDS。 OCD 还与 MedStar 乔治敦大学医院建立并支持独特的住院医师计划。 NINDS/NIH 与乔治城大学 ACGME 认可的神经病学住院医师项目之间的教育合作伙伴关系，使住院医师有机会在研究方法和人类受试者调查方面打下坚实的基础，从而创造独特的临床经验和研究培训机会，从而培养神经科学研究的未来领导者。 OCD 还提供 K22 职业转型奖，以支持校内研究项目的临床研究员。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旅行奖励。 此外，OCD 还通过任命临床助理研究者 (ACI) 来支持 IRP 中新临床研究者的发展，并授予亨利·麦克法兰临床独立过渡奖。该奖项将临床研究金和新的研究者角色联系起来。 OCD 设有一个奖学金委员会，负责审查并建议使用 OCD 资金资助临床研究员。 OCD 管理招聘临床医生、护理人员、ACI 和其他需要的临床人员的选拔委员会。