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

NIDDK 项目领域疾病的多学科协作临床研究、方案导航、监测合规性和其他临床服务

基本信息

批准号：
10008882
负责人：
James Balow
金额：
$ 82.39万
依托单位：
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

项目摘要

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

协议导航服务包括：培训研究支持团队成员在协议开发，科学审查，良好的临床实践，IND和其他人类研究监管要求，IRB提交，不良事件报告，现场启动，协议监控和合规性的培训。 IRB管理服务包括：维护临床协议，同意书和审查文件的电子数据库。协议预评论，年度审查，良好临床实践中必要的临床研究培训的文件，报告要求，数据共享，潜在研究者的确定，潜在研究人员的冲突，IRB分钟的管理和其他与协议有关的文档，与OHSRP联络。员工证书服务包括：凭证的NIDDK临床工作人员具有相关的专业知识，以支持所有研究所和中心在壁内研究计划中进行的临床研究的患者护理需求。 NIDDK临床医生提供的咨询相互作用在糖尿病，内分泌学，代谢，胃肠病学，肝病学，肾脏病和血液学领域具有专业知识是为了向NIH临床研究中心的整个临床研究中心提供专业医疗服务所必需的。除了患者支持服务之外，这些咨询相互作用还会进行协作临床研究，以推动对疾病自然史的研究，诊断和治疗的新方法以及对疾病发病机理和病理生理学的理解。临床服务的例子包括： 1。血糖管理服务涉及胰岛素缺乏或胰岛素抗性糖尿病的患者的全面管理，包括胰岛素剂量，血糖监测和胰岛素泵管理。 2。内分泌，胃肠病学，肝病学，代谢，肾脏病和囊性纤维化的咨询服务。 3。生物座席：收集，条形码，索引，存储和检索人类样品 4。生物统计学支持，用于开发，监测，分析临床研究方案