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 在临床和翻译研究方面表现出色。在此应用程序中，我们提供有关产科的信息 为母婴医学部(MFMU)进行临床试验的服务和经过证明的记录 宾夕法尼亚大学卫生系统(宾夕法尼亚大学)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，大约有9500名女性 在宾夕法尼亚大学分娩，这些妇女中的许多都是高危孕妇。宾夕法尼亚大学的产科人口 也有不同的种族和民族背景，这是注册MFMU网络的重要资产 学习。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经过验证的记录，以满足正在进行的MFMU的所有目标 网络研究。宾夕法尼亚大学MFMU网络临床中心的主要资产是：1)一名经验丰富的护士 监督所有临床研究的协调员；2)第二名注册护士，他将对 完成网络的PACT研究；3)一名项目经理，协助护士协调员 管理研究方案；4)一名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)监督收集、处理和存储 生物质谱学；6)全天候模式，每天在HUP和HUP的劳动力车间提供研究人员覆盖 PAH，夜间电话覆盖；7)在HUP和PAH的所有主要临床地点招募门诊人员；以及8) 由研究人员和调查人员编写的数据摘要手册，确保准确确定 电子病历中的临床数据。MFMU网络研究人员与 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网络临床中心调查组 宾夕法尼亚大学有指导多中心研究的丰富经验，每个研究人员都有一项令人兴奋的研究 议程为MFMU网络增加了独特的视角。派(S·帕里)担任TXA协议和 生物武器委员会，而候补的PI(S·斯里尼瓦斯)在PACT议定书委员会任职，并在 分析工作组。调查人员为这一应用程序提出了三个具体目标：1)工作 在MFMU网络的协作环境内执行正在进行的 MFMU网络研究；2)为MFMU网络研究提供最高质量的数据 及时提供这些数据；以及3)参与分析和发表研究报告 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.