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 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 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. 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 an 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 Neuroimmunology Clinic and the Neuro-HIV Clinic. A new ALS clinic has been started. 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 neurology 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. Two fellows were successful in getting the K22 award in FY18 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. One ACI was recruited in FY18 with an ongoing search committee to identify an additional candidates. 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. Seven fellows were supported by OCD in FY18.
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