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NIH/NIDCR Clinical Research Operations and Management Support (NIDCR CROMS)

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 on the cause, incidence, prevalence, prevention, and treatment of oral, dental, and craniofacial diseases, and other related diseases and disorders.

Project Information: Through the CROMS contract with the NIDCR, Rho has provided full-service or tailored clinical research support services to more than 75 clinical studies that are supported by the NIDCR’s Intramural and Extramural programs. This contract supports Phase I-III clinical trials as well as population-based, epidemiologic, behavioral, and natural history studies in areas such as Sjogren’s Syndrome, hypoparathyroidism, oral wound healing, head and neck squamous cell carcinoma, and periodontal disease. The contract provides the NIDCR with infrastructure support that consists of both clinical research management and the creation of operational and oversight tools to assist in the effective administration and coordination of its clinical research program.  Operational and oversight tools include, but are not limited to, the following:

  • A Clinical Tool Box that provides templates, guidance documents, and other tools for CROMS staff and NIDCR administrators, intramural and extramural investigators, and site staff
  • Web-based information management systems to facilitate effective administration and coordination for NIDCR’s research programs

Services: 

  • Biostatistics and Statistical Programming
  • Clinical Research Operations And Study Monitoring
  • Data Management And Analysis
  • Manuscript and Regulatory Document Submission 
  • Project and Site Management
  • Protocol Design/Development
  • Regulatory Consulting and Management
  • Safety Monitoring/Pharmacovigilance 
  • General Logistical Support and Administrative Coordination
  • Information Management Systems
  • Training and Training-Related Activities
  • Process Documentation Development (e.g., Standard Operating Procedures)

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