Clinical Centers for Completion of Ongoing MFMU Network Protocols

完成正在进行的 MFMU 网络协议的临床中心

基本信息

批准号：
10379414
负责人：
SAMUEL I. PARRY
金额：
$ 32.5万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10379414
关键词：
COVID-19 Caring Clinical Data Clinical Research Clinical Trials Collection Computerized Medical Record Conduct Clinical Trials Data Data Coordinating Center Discipline of obstetrics Enrollment Ensure Environment Fetus Floor Functional disorder Funding Genetic Genomics Gynecology Health system High Risk Woman High-Risk Pregnancy Hospitals Leadership Longterm Follow-up Manuals Maternal and Child Health Maternal-Fetal Medicine Units Network Maternal-fetal medicine Meta-Analysis Modeling Multicenter Neonatal Research Network Multicenter Studies Multicenter Trials Neonatal Nurses Nursing Research Observational Study Outcome Outpatients Participant Pediatric Hospitals Pennsylvania Performance Philadelphia Population Positioning Attribute Pravastatin Premature Birth Principal Investigator Proteomics Protocols documentation Publications Randomized Clinical Trials Registered nurse Registries Research Research Infrastructure Research Personnel Role Services Site Sleep Time Translational Research United States National Institutes of Health Universities University Hospitals Woman Work clinical center clinical research site cohort collaborative environment demographics electronic data experience follow-up high risk improved improved outcome maternal outcome neonatal outcome operation perinatal medicine premature racial and ethnic racial diversity recruit reproductive working group

项目摘要

Abstract The University of Pennsylvania’s Department of Obstetrics and Gynecology reflects a long tradition of excellence in clinical and translational research. In this application, we provide information on our obstetrical service and our proven track record for conducting clinical trials for the Maternal-Fetal Medicine Units (MFMU) Network at the two hospitals in the University of Pennsylvania Health System (Penn) – the Hospital of the University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH). Each year, approximately 9,500 women are delivered at Penn, and many of these women are high-risk pregnancies. The obstetric population at Penn also has a diverse racial and ethnic background, which is an important asset for enrollment in MFMU Network studies. Over the past five years, MFMU Network investigators and research staff at Penn have developed the clinical research infrastructure and proven track record to meet all of the objectives of the ongoing MFMU Network studies. Key assets of the MFMU Network clinical center at Penn are: 1) an experienced Nurse Coordinator who oversees all of the clinical studies; 2) a second registered nurse who will be critical for completion of the network’s PACT study; 3) a project manager who assists the Nurse Coordinator with management of the study protocols; 4) an experienced clinical research coordinator who is certified to conduct all MFMU Network studies; 5) a biospecimens technician who oversees collection, processing, and storage of biospecimens; 6) a 24/7 model that provides research staff coverage every day on the labor floors at HUP and PAH with call coverage at night; 7) outpatient recruitment at all major clinical sites at HUP and PAH; and 8) data abstraction manuals written by research staff and investigators that ensure accurate ascertainment of clinical data from the electronic medical record. The MFMU Network research staff work closely with coordinators from the Neonatal Research Network at the Children’s Hospital of Philadelphia to provide neonatal follow-up for MFMU Network studies. The investigative team for the MFMU Network clinical center at Penn has significant experience directing multicenter studies, and each investigator has an exciting research agenda that adds unique perspectives to the MFMU Network. The PI (S Parry) serves on the TXA protocol and biospecimen committees, while the alternate PI (S Srinivas) serves on the PACT protocol committee and meta- analysis work group. The investigators propose three specific aims for this application: 1) To work within the collaborative environment of the MFMU Network toward the implementation of the ongoing MFMU Network studies; 2) To provide the highest quality data for MFMU Network studies and to provide these data in a timely fashion; and 3) To be involved in the analysis and publication of studies performed by the MFMU Network. The investigative team at Penn looks forward to continuing to work with the other clinical centers and the Data Coordinating Center to complete the ongoing MFMU Network protocols.

抽象的宾夕法尼亚大学妇产科体现了悠久的传统卓越的临床和转化研究在此应用程序中，我们提供有关我们产科的信息。服务以及我们为母胎医学单位 (MFMU) 进行临床试验的良好记录宾夕法尼亚大学医疗系统 (Penn) 的两家医院的网络 – the Hospital of the 宾夕法尼亚大学 (HUP) 和宾夕法尼亚医院 (PAH) 每年约有 9,500 名女性。在宾夕法尼亚大学分娩，其中许多妇女是宾夕法尼亚大学的高危孕妇。还拥有多元化的种族和民族背景，这是 MFMU 网络入学的重要资产在过去的五年里，宾夕法尼亚大学 MFMU 网络的研究人员和研究人员开发了临床研究基础设施和良好的业绩记录可满足正在进行的 MFMU 的所有目标宾夕法尼亚大学 MFMU 网络临床中心的网络研究的主要资产是：1) 经验丰富的护士。监督所有临床研究的协调员；2) 对临床研究至关重要的第二名注册护士；完成网络的 PACT 研究； 3) 协助护士协调员的项目经理；研究方案的管理； 4) 一名经验丰富、经过认证的临床研究协调员所有 MFMU 网络研究；5) 一名生物样本技术人员，负责监督生物样本的收集、处理和储存 6) 24/7 模式，为 HUP 的研究人员提供每天的工作保障； PAH 夜间有电话覆盖；7) 在 HUP 和 PAH 的所有主要临床中心招募门诊患者；8) 由研究人员和调查人员编写的数据提取手册，确保准确确定 MFMU 网络研究人员与电子病历中的临床数据密切合作。费城儿童医院新生儿研究网络的协调员提供 MFMU 网络研究的新生儿随访 MFMU 网络临床中心的调查小组。宾夕法尼亚大学在指导多中心研究方面拥有丰富的经验，每位研究者都有令人兴奋的研究为 MFMU 网络增添独特视角的议程 PI (S Parry) 服务于 TXA 协议和生物样本委员会，而候补 PI (S Srinivas) 则在 PACT 协议委员会和元- 分析工作组提出了该应用程序的三个具体目标：1）工作。在 MFMU 网络的协作环境中，以实施正在进行的 MFMU 网络研究；2) 为 MFMU 网络研究提供最高质量的数据并及时提供这些数据；以及 3) 参与研究的分析和发表宾夕法尼亚大学的调查团队期待继续与 MFMU 网络合作。其他临床中心和数据协调中心完成正在进行的 MFMU 网络协议。