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

协议导航服务包括： 培训研究支持团队成员有关方案制定、科学审查、良好临床实践、INDS和其他人类研究法规要求、IRB提交、不良事件报告、网站启动、方案监测和遵从性的方法。 IRB管理服务包括： 维护临床方案、同意书和审查文件的电子数据库。方案预审查、年度审查、记录必要的临床研究培训、良好临床实践、报告要求、数据共享、确定潜在的研究者利益冲突、管理IRB会议记录和其他与方案相关的文件、与OHSRP联络。 工作人员发证服务包括： 有资格证书的NIDDK临床工作人员拥有必要的相关专业知识，以支持参与校内研究计划中所有研究所和中心进行的临床研究的人类受试者的患者护理需求。NIDDK临床医生需要在糖尿病、内分泌学、新陈代谢、胃肠病学、肝病、肾脏病和血液学领域的专业知识提供咨询互动，才能为整个NIH临床研究中心的患者提供专门的医疗服务。除了患者支持服务，这些咨询互动导致合作的临床调查，以促进对疾病自然历史的研究，新的诊断和治疗方法，以及促进对疾病发病机制和病理生理学的理解。 临床服务的例子包括： 1.血糖管理服务涉及对胰岛素缺乏或胰岛素抵抗的糖尿病患者的全面管理，包括胰岛素剂量、血糖监测和胰岛素泵管理。 2.内分泌、胃肠病、肝病、代谢、肾病、囊性纤维化等方面的咨询服务。 3.生物储存库：收集、条形码、索引、存储和检索人体样本 4.为制定、监测、分析临床研究方案提供生物统计学支持

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