NIDCR DIR Clinical Support Services

National Institute Of Dental & Craniofacial Research

Investigators

Linked publications, trials & patents

Abstract

1) Support the clinical research at NIDCR DIR through assistance with protocol writing, scientific reviewing, regulatory compliance (FDA and OHRP), database development, AE/SAE reporting, subject scheduling, study coordinator support and research nursing support In FY21, the DCRC improved the support services for clinical research protocols through enhanced database development and management, virtual office processes, development of new scientific review processes, and new biostatistical support. New clinical and patient safety activities were reviewed and added to overall services, including regular weekly clinic huddles and continuation of biannual emergency simulations. Partnership and increased utilization of the Office of Research Support and Coordination (CC) for support of human subject studies. The research support staff were instrumental in initiating a COVID-19 Saliva study during the pandemic shut down in March, 2020. New methodologies and approval mechanisms had to be considered during the COVID shut down. We were still able to initiate subject enrollment within 4 weeks of study concept. The COVID-19 study is ongoing. 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls. Efficient study monitoring through partnership with OCTOM was maintained. In FY21, NIDCR supported a standing DSMC, internal quality monitoring, and other oversight activities for all clinical research. All studies have been in compliance, including the newly initiated COVID Saliva study. All monitoring efforts have been conducted remotely during the COVID pandemic. NIDCR studies are FDAA reporting compliant. 3) Support the Institutional Review Board (IRB) In FY21, the NIDCR human subject protocols are overseen by the central NIH IRB. Protocol navigation, research oversight and monitoring was improved through the efforts of the NIDCR Clinical Operations Manager, Ms. Beth Brilliant and study navigation with Rachel Wagner and Kesha Stone (ORSC). All studies continue to have appropriate scientific review and institute review. 4) Provide dental and oral surgery and metabolic bone diseases consultations for subjects in the Clinical Center, at NIDCR and at other NIH Institutes In FY21 the NIDCR clinical staff supported NIDCR DIR clinical research and provided oral surgery and dental consultations and care to other NIH institutes. The overall number of patient/subject visits is nearly back to pre-pandemic levels. The hospital dental staff have implemented several infection control and safety measures with the support of Hospital Epidemiology Service. 5) Support through the Office of the Clinical Director (OCD) In FY21, the OCD continues to facilitate clinical research development, clinical protocol performance and quality, maintenance of staff credentials and hospital privileges. The CD has developed a tracking database for trainees.