NIH/NIDCR Clinical Research Operations and Management Support

Project: Clinical Research Operations and Management Support (CROMS)

Sponsor: HHS/NIH/National Institute of Dental and Craniofacial Research (NIDCR)

Prime: Rho

Project Status: Active

Project Start Date: September 2008

Diseases: The NIDCR supports clinical research designed to answer critical questions on the cause, incidence, prevalence, prevention, and treatment of dental, oral, and craniofacial, diseases, and disorders. Specific areas of research include, but are not limited to: Sjögren’s Syndrome, hypoparathyroidism, oral wound healing, head and neck squamous cell carcinoma, periodontal disease, and oral health promotion.

Project Information: Through the CROMS contract with the NIDCR, Rho has provided clinical research management, oversight, and operations support services to more than 200 clinical trials and observational studies supported by the NIDCR’s Intramural and Extramural programs. Studies range from small, short-term, pilot evaluations involving a single domestic site, to large, multi-year, multi-site clinical studies.

Rho also provides NIDCR staff with:

adjunct expertise and resources to assure sound and efficient clinical study documentation, clinical site monitoring, data and safety monitoring, data management support, statistical support, and regulatory compliance
systems and tools to both assist clinical researchers in their operational activities as well as to assist the NIDCR in the effective oversight and administration of its clinical research portfolio

Services:

Clinical Research Policy, Guidelines, and Study Templates
Assessment of Clinical Site Preparedness and Quality Management Program
Protocol Development and Study Documents/Materials Preparation
Study Data Collection, Management and Quality Control
Training and Training-related Activities
Regulatory Consultation/Submission Support, FDA Interface Coordination
Risk-based Clinical Site Monitoring
NIDCR Safety Reporting Program
Statistical Support
Data & Safety Monitoring Committee (DSMC) Support
Information Management Systems
General, Logistical Support, Administrative Coordination & Technical Support

Selected Publications:

Boyce, A. M., Shawker, T. H., Hill, S. C., Choyke, P. L., Hill, M. C., James, R., Yovetich, N.A., Collins, M.T., Gafni, R. (2013). Ultrasound is superior to computed tomography for assessment of medullary nephrocalcinosis in hypoparathyroidism. Journal of Clinical Endocrinology and Metabolism, 98(3), 989-994.

Gafni, R.I, Guthrie, L.C., Kelly, M.H., Brilliante, B.A., Christie, C.M., Reynolds, J.C., Yovetich, N.A., James, R. Collins, M.T. Transient Increased Calcium and Calcitriol Requirements After Discontinuation of Human Synthetic Parathyroid Hormone 1-34 (hPTH 1-34) Replacement Therapy in Hypoparathyroidism. Journal of Bone Mineral Research. 2015 Nov;30(11):2112-8. doi: 10.1002/jbmr.2555. Epub 2015 Aug 3.

Abram, T.J.*, Floriano, P.N.*, Christodoulides, N., James, R., Kerr, A.R., Thornhill, M.H., Redding, S.W., Vigneswaran, N., Speight, P.M., Vick, J., Murdoch, C., Freeman, C., Hegarty, A.M., D’Apice, K., Phelan, J.A., Corby, P.M., Khouly, I., Bouquot, J., Demian, N.M., Weinstock, Y.E., Rowan, S., Yeh, C., McGuff, H.S., Miller, F.R., Gaur, S., Karthikeyan, K., Taylor, L., Le, C., Nguyen, M., Talavera, H., Raja, R., Wong, J., McDevitt, J.T. (2016) ‘Cytology-on-a-chip’ based sensors for monitoring of potentially malignant oral lesions. Oral Oncology, 60:103-111. *equal contributors

Speight, P.M., Abram, T.J.*, Floriano, P.N.*, James, R., Vick, J., Thornhill, M.H., Murdoch, C., Freeman, C., Hegarty, A., D’Apice, K., Kerr, A.R., Phelan, J., Corby, P., Khouly, I., Vigneswaran, N., Bouquot, J., Demian, N.M., Weinstock, Y.E., Redding, S.W., Rowan, S., Yeh, C., McGuff, H.S., Miller, F.R., McDevitt, J.T. (2015) Interobserver agreement in dysplasia grading: toward an enhanced gold standard for clinical pathology trials. Oral Surgery Oral Medicine Oral Pathology Oral Radiology, 120(4):474-482. *equal contributors