As part of its overall research mission, the National Institute of Dental and Craniofacial Research (NIDCR) supports clinical research on the cause, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. The NIDCR supports clinical research through the extramural community and in the NIDCR intramural research program. Extramural studies conducted through the funding of research grants and contracts and within the NIDCR intramural research program, include Phase I-III clinical trials as well as population-based, epidemiologic, behavioral and natural history studies. The purpose of this Clinical Research Operations and Management Support (CROMS) contract is to provide comprehensive clinical research operations support, management and data coordinating services for clinical research sponsored by NIDCR's extramural and intramural research divisions. The contract will provide NIDCR with clinical research management support and oversight tools to assist in the effective administration and coordination of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study design, study execution, data management and analysis, and regulatory compliance. Specific tasks performed will vary by clinical study and clinical site, and will be dependent on the study protocol, standard operating procedures, needs of the clinical sites and other available resources or support.
