Clinical Centers for Completion of Ongoing MFMU Network Protocols

摘要 宾夕法尼亚大学的妇产科反映了一个悠久的传统， 卓越的临床和转化研究。在这个应用程序中，我们提供有关我们的产科信息， 服务和我们在母胎医学单位（MFMU）进行临床试验的良好记录 宾夕法尼亚大学卫生系统（Penn）两所医院的网络- 宾夕法尼亚大学（HUP）和宾夕法尼亚医院（PAH）。每年约有9,500名妇女 都是在宾夕法尼亚大学分娩的，其中许多妇女都是高危妊娠。宾夕法尼亚大学的产科人口 也有一个不同的种族和民族背景，这是一个重要的资产，在MFMU网络注册 问题研究在过去的五年里，宾夕法尼亚大学的MFMU网络调查人员和研究人员开发了 临床研究基础设施和良好的跟踪记录，以满足正在进行的MFMU的所有目标 网络研究。宾夕法尼亚州MFMU网络临床中心的关键资产是：1）经验丰富的护士 监督所有临床研究的协调员; 2）第二名注册护士， 完成网络的PACT研究; 3）项目经理，协助护士协调员 研究方案的管理; 4）经验丰富的临床研究协调员，经认证可进行 所有MFMU网络研究; 5）生物标本技术员，负责监督收集，处理和储存 生物标本; 6）一个24/7的模式，每天在HUP的劳动层提供研究人员覆盖， 夜间呼叫覆盖的PAH; 7）HUP和PAH所有主要临床研究中心的门诊招募;以及8） 由研究人员和调查人员编写的数据抽象手册，确保准确确定 电子病历中的临床数据。MFMU网络研究人员与以下机构密切合作： 来自费城儿童医院新生儿研究网络的协调员， MFMU网络研究的新生儿随访。MFMU网络临床中心的调查小组在 宾大在指导多中心研究方面有着丰富的经验，每位研究者都有令人兴奋的研究成果。 该议程为MFMU网络增添了独特的视角。PI（S Parry）服务于TXA协议， 生物标本委员会，而候补PI（S Srinivas）在PACT方案委员会和Meta 分析工作组。研究人员提出了三个具体的目的，为这个应用程序：1）工作 在MFMU网络的协作环境中， MFMU网络研究; 2）为MFMU网络研究提供最高质量的数据， 及时提供这些数据; 3）参与研究的分析和出版 由MFMU网络执行。宾夕法尼亚大学的调查小组期待着继续与 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。

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.