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 FY18, 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. 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls In FY18, NIDCR supported a standing DSMC, internal quality monitoring, and other oversight activities for all clinical research. 3) Support the Institutional Review Board (IRB) In FY18, the NIDCR continued to work with the CNS IRB to improve protocol management and procedures for review through the efforts of the NIDCR Clinical Operations Manager, Ms. Tammy Yokum and Ms. Beth Brilliant. 4) Provide dental and oral surgery medical consultations for subjects in the Clinical Center, at NIDCR and at other NIH Institutes In FY18 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 remains stable in the last year. 5) Support the Clinical Director's (CD) Office In FY18, the DCRC supported the CD Office to facilitate clinical research development, clinical protocol performance and quality, maintenance of staff credentials and hospital privileges. The new CTMS project is ongoing and will improve clinical research oversight and management. The CD has developed a tracking database for trainees.
|Bassim, Carol W; Ambatipudi, Kiran S; Mays, Jacqueline W et al. (2012) Quantitative salivary proteomic differences in oral chronic graft-versus-host disease. J Clin Immunol 32:1390-9|