Multidisciplinary Collaborative Clinical Research, Protocol Navigation, Monitoring Compliance, and Other Clinical Services in NIDDK Program Area Diseases

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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