Pelvic Floor Disorders Network Data Coordinating Center: Administrative Supplement: Noncontinuing Sites

盆底疾病网络数据协调中心：行政补充：非连续站点

• 批准号: 10751080
• 负责人: MARIE G GANTZ
• 金额: $ 3万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-08 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10751080
• 关键词: Address; Adherence; Administrative Supplement; Biometry; Caring; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Communication; Communication Tools; Data Analyses; Data Collection; Data Coordinating Center; Diagnosis; Equipment and Supplies; Genetic; International; Journals; Leadership; Life; Machine Learning; Mission; Monitor; Multicenter Studies; National Institute of Child Health and Human Development; Observational Study; Outcome Measure; Patient Outcomes Assessments; Pelvic Floor Disorders; Persons; Pharmaceutical Preparations; Prevention; Procedures; Productivity; Protocols documentation; Psychometrics; Publications; Qualifying; Reporting; Research; Research Design; Resources; Safety; Services; Site; Statistical Data Interpretation; Training; Woman; bench-to-bedside translation; data management; data pipeline; data quality; design; electronic data capture system; experience; health economics; improved; innovation; meetings; mobile application; multidisciplinary; payment; protocol development; quality assurance; remote monitoring; research study; support network; symposium; translational study; web platform

Contact PD/PI: GANTZ, Marie PROJECT SUMMARY/ABSTRACT RTI International serves as the data coordinating center (DCC) for the NICHD Pelvic Floor Disorders Network (PFDN) in support of its mission to improve the care of women with pelvic floor disorders (PFDs) by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. RTI is providing the Network with statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, the DCC (1) leads innovative study designs and analyses to address challenges specific to PFD research, including bench-to-bedside translational studies, by providing expertise in biostatistics, statistical genetics, psychometrics, health economics, machine learning, and other fields and collaborating with clinical investigators to develop rigorously designed studies with outcome measures important to women with PFDs; (2) provides tools for communication and collaboration to facilitate rapid development of protocols and web-based systems for electronic data capture (including direct capture of patient-reported outcomes via mobile applications), biospecimen tracking, omics data pipelines, and training; (3) conducts data management, quality assurance, and monitoring procedures throughout the life of each study, capitalizing on centralized and remote monitoring capabilities for efficient use of network resources; (4) reports on data quality, protocol adherence, and safety, and perform statistical analysis for presentation at national and international conferences, and publication in top-tiered journals; and (5) coordinates remote and in-person meetings, manage subcontracts, provide automatic capitation payments to sites, and manage biospecimen transport and storage, study drug acquisition, and equipment and supplies distribution as needed to support network studies. Project Summary/Abstract

联系PD/PI：Gantz，Marie 项目摘要/摘要 RTI International是NICHD骨盆底的数据协调中心（DCC） 疾病网络（PFDN），以支持其改善骨盆女性的护理的使命 通过进行精心设计的多中心观察研究和 临床试验，以告知诊断，预防和治疗。 RTI为网络提供 通过数据进行研究设计和数据分析和运营支持方面的统计领导 管理和后勤服务。具体而言，DCC（1）领导创新研究设计 并分析以应对PFD研究特定的挑战，包括基准对床位 翻译研究，通过提供生物统计学，统计遗传学，心理计量学， 健康经济学，机器学习和其他领域，并与临床研究人员合作 使用对PFD女性重要的结果措施进行严格设计的研究； （2）提供了沟通和协作的工具，以促进 用于电子数据捕获的协议和基于Web的系统（包括直接捕获 通过移动应用程序报告的患者报告结果），生物测量跟踪，OMICS数据管道， 和培训； （3）进行数据管理，质量保证和监视程序 在每个研究的整个生命中，都利用集中式和远程监控功能 有效利用网络资源； （4）报告数据质量，协议依从性和 安全并进行统计分析以在国家和国际上进行介绍 会议，并在顶级期刊上出版； （5）协调远程和面对面的 会议，管理分包合同，向网站提供自动人力付款并管理 生物测量运输和存储，学习药物获取以及设备和用品 根据需要分配网络研究。 项目摘要/摘要