NIDCR DIR Clinical Support Services

National Institute Of Dental & Craniofacial Research

Investigators

Linked publications & trials

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 FY19, the DCRC improved the support services for clinical research protocols through enhanced database development and management, intranet functionality, development of e-regulatory binders, and research nursing support. New clinical and patient safety activities were reviewed and added to overall services. A new Clinical Trials Management System project is in use this year. Efficient study monitoring through partnership with OCTOM was maintained. Partnership and increased utilization of the Office of Research Support and Coordination (CC) for support of human subject studies. 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls In FY19, NIDCR supported a standing DSMC, internal quality monitoring, and other oversight activities for all clinical research. 3) Support the Institutional Review Board (IRB) In FY19, the NIDCR continued to work with the CNS IRB through the transition of all human subject protocols to 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 OCTOM. 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 FY19 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 has grown due to the increased activity of all protocols and the addition of a new hospital dentist. 5) Support for the Office of the Clinical Director (OCD) In FY19, the DCRC supported the OCD to facilitate clinical research development, clinical protocol performance and quality, maintenance of staff credentials and hospital privileges. The new CTMS project is functional and improves clinical research oversight and management. The CD has developed a tracking database for trainees.