Protocol navigation services include: Training of research support team members on approaches to protocol development, scientific review, Good Clinical Practice, INDs, and other human research regulatory requirements, IRB submissions, adverse event reporting, site initiation, protocol monitoring and compliance. IRB administration services include: Maintenance of electronic databases for clinical protocols, consent forms and review documents. Protocol pre-reviews, annual reviews, documentation of requisite clinical research training in Good Clinical Practice, Reporting Requirements, Data Sharing, ascertainment of potential investigator conflicts-of-interest, management of IRB minutes and other protocol-related documents, liaison with OHSRP. Staff credentialing services include: Credentialed NIDDK clinical staff members have relevant expertise necessary to support patient care needs of human subjects involved in clinical research conducted by all institutes and centers in the intramural research program. Consultative interactions provided by NIDDK clinicians with expertise in the fields of diabetes, endocrinology, metabolism, gastroenterology, hepatology, nephrology and hematology are required for delivery of specialized medical services to patients throughout the Clinical Research Center at NIH. Beyond patient support services, these consultative interactions lead to collaborative clinical investigations to advance the study of natural history of disease, new approaches to diagnosis and treatment, as well as advancing the understanding of disease pathogenesis and pathophysiology. Examples of clinical services include: 1. Blood Glucose Management Service involves comprehensive management of patients with insulin deficient or insulin resistant diabetes mellitus, including insulin dosing, blood glucose monitoring, and insulin pump management. 2. Consultation services in endocrinology, gastroenterology, hepatology, metabolism, nephrology, and cystic fibrosis. 3. Biorepository: collection, barcoding, indexing, storing, and retrieving human samples 4. Biostatistical support for developing, monitoring, analyzing clinical research protocols
| Brown, Rebecca J; Araujo-Vilar, David; Cheung, Pik To et al. (2016) The Diagnosis and Management of Lipodystrophy Syndromes: A Multi-Society Practice Guideline. J Clin Endocrinol Metab 101:4500-4511 |
| Sylvetsky, Allison C; Brown, Rebecca J; Blau, Jenny E et al. (2016) Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond) 13:71 |
| Zhou, Hua; Hasni, Sarfaraz A; Perez, Paola et al. (2013) miR-150 promotes renal fibrosis in lupus nephritis by downregulating SOCS1. J Am Soc Nephrol 24:1073-87 |
| Alvarez-Downing, Melissa M; Kamal, Natasha; Inchauste, Suzanne M et al. (2013) The role of surgery in the management of patients with refractory chronic granulomatous disease colitis. Dis Colon Rectum 56:609-14 |
| Fan, Xiying; Upadhyaya, Bhaskar; Wu, Liming et al. (2012) CD40 agonist antibody mediated improvement of chronic Cryptosporidium infection in patients with X-linked hyper IgM syndrome. Clin Immunol 143:152-61 |
| Monti, Daniel A; Mitchell, Edith; Bazzan, Anthony J et al. (2012) Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One 7:e29794 |
| Castillo, Darleen C; Ramsey, Natalie Lm; Yu, Sophia Sk et al. (2012) Inconsistent Access to Food and Cardiometabolic Disease: The Effect of Food Insecurity. Curr Cardiovasc Risk Rep 6:245-250 |
| Lungu, Andreea O; Zadeh, Elika Safar; Goodling, Anne et al. (2012) Insulin resistance is a sufficient basis for hyperandrogenism in lipodystrophic women with polycystic ovarian syndrome. J Clin Endocrinol Metab 97:563-7 |
| Leiding, Jennifer W; Freeman, Alexandra F; Marciano, Beatriz E et al. (2012) Corticosteroid therapy for liver abscess in chronic granulomatous disease. Clin Infect Dis 54:694-700 |
| Waldman, Meryl; Austin 3rd, Howard A (2012) Treatment of idiopathic membranous nephropathy. J Am Soc Nephrol 23:1617-30 |
Showing the most recent 10 out of 17 publications
