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. 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 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. 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), PTMS 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. The OCD hired an additional biostatistician in FY13 to further support investigators. 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 annual investigators retreat for clinical faculty where clinical policies and training are reviewed and discussed for implementation. The OCD also supports multidisciplinary inter-institutional clinics, including the Parkinson's Disease Clinic, the Neuroimmunology Clinic and the Neuro-HIV Clinic. 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. 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. The OCD also supports the development of new clinical investigators in the IRP with the Henry McFarland Clinical Transition to Independence Award, an award that bridges clinical fellowship and new investigator roles. The OCD also established a Fellowship Committee that reviews and recommends funding of clinical fellows using OCD funds. Three fellows were supported by OCD in FY13. The OCD has established a Translational Neuroscience Center, which has a drug development unit, a neuroregeneration unit, a clinical proteomics unit and a clinical trials unit. The center supports the needs of the researchers in NINDS and aims to improves diagnostics and therapeutics for neurological diseases. The OCD has taken a further role in supporting research by organizing search committees for tenure track investigator positions, Staff Clinicians, and Staff Scientists. During FY13, there were a total of six search committees from which two tenure track investigators were hired. Two additional candidates are currently in discussion for positions in the stroke program and another is currently interviewing for the Clinical Trials Program Director.
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