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，玛丽 项目总结/摘要 RTI International是NICHD骨盆底的数据协调中心（DCC）。 疾病网络（PFDN），以支持其使命，以改善对患有盆腔炎的妇女的护理 通过进行精心设计的多中心观察性研究， 临床试验为诊断、预防和治疗提供信息。RTI正在为网络提供 在研究设计和数据分析方面的统计领导作用，以及通过数据提供业务支持 管理和后勤服务。具体而言，DCC（1）引领创新研究设计 和分析，以应对PFD研究的具体挑战，包括从实验室到床边的 翻译研究，通过提供生物统计学，统计遗传学，心理测量学， 卫生经济学、机器学习和其他领域，并与临床研究人员合作 开展设计严谨的研究，并对患有PFDs的女性进行重要的结果测量; (2)提供沟通和协作工具，以促进 电子数据采集协议和基于网络的系统（包括直接采集 经由移动的应用的患者报告的结果），生物样本跟踪，组学数据管道， （3）进行数据管理、质量保证和监测程序 在每项研究的整个生命周期中，利用集中和远程监测功能 有效利用网络资源;（4）报告数据质量、协议遵守情况， 安全性，并进行统计分析，以在国家和国际 会议，并在顶级期刊上发表;以及（5）协调远程和面对面 会议，管理分包合同，向站点提供自动按人头付费，并管理 生物标本运输和储存、研究药物采集以及设备和供应品 根据需要分发，以支持网络研究。 项目总结/摘要