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 FY16, 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. A new Clinical Trials Management System project was initiated this year. 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls In FY16, NIDCR supported a standing DSMC, internal quality monitoring, and other oversight activities for all clinical research. 3) Support the NIDCR Institutional Review Board (IRB) In FY16, 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. 4) Provide dental and oral surgery medical consultations for subjects in the Clinical Center, at NIDCR and at other NIH Institutes In FY16 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 dramatically increased in the last year. 5) Support the Clinical Director's (CD) Office In FY16, 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.
| 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 |
