Collaborative Pediatric Critical Care Research Network - Clinical Site

项目摘要-加州大学联盟 加州大学旧金山弗朗西斯科（UCSF）贝尼奥夫儿童医院一直是 尤妮斯·肯尼迪·施莱佛国立儿童健康与发展研究所（NICHD）协作儿科 重症监护研究网络（CPCCRN）自2014年以来（第三周期），并热衷于参与作为一个 新组织和扩展的网络中的临床中心。在第三个周期，Anil Sapru博士（原PI） 搬迁到加州大学，洛杉矶（UCLA）和UCLA加入加州大学旧金山分校作为一个财团网站。更 最近，UCSF与前奥克兰儿童医院建立了联系，从而建立了新的贝尼奥夫儿童医院。 在旧金山弗朗西斯科（BCHSF）和奥克兰（BCHO）的医院。因此，BCHSF和BCHO，沿着UCLA，将 包括临床联合体或中心站点。我们会和我们的辅助部队 地点：加州大学戴维斯分校儿童医院。与此合作伙伴一起，我们的网站将提供 获得104个PICU床位，每年约有4500人入院，使我们能够充分参与 “脓毒症诱导的MODS中的个性化免疫调节”试验在本试验的总体组成部分中描述。 应用程序.我们的网站提案有三个具体目标：具体目标1。积极配合实施 参加委员会的工作，包括参加指导委员会和其他委员会，出席会议， 促进与数据协调中心的合同，并遵守标准操作 网络的程序和性能预期。具体目标2。为年轻人提供机会 研究者参加CPCCRN会议、委员会或试验实施，目的是 将这些有才华的人培养成可供资助的临床科学家。具体目标3。贯彻 个性化免疫调节在脓毒症诱导的MODS试验中的应用，包括通过培训招募患者 研究人员，遵守研究方案，及时输入数据，并完全遵守药物临床试验质量管理规范 实践（GCP）和其他法规要求。

PROJECT ABSTRACT - University of California Consortium The University of California, San Francisco (UCSF) Benioff Children’s Hospital has been a Clinical Site in the Eunice Kennedy Shriver National Institutes of Child Health and Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN) since 2014 (3rd cycle) and is enthusiastic about participating as a Clinical Hub in the newly organized and expanded network. During the 3rd cycle, Dr Anil Sapru (original PI) relocated to University of California, Los Angeles (UCLA) and UCLA joined UCSF as a consortium site. More recently UCSF has affiliated with the former Children’s Hospital Oakland resulting in the new Benioff Children’s Hospitals at San Francisco (BCHSF) and Oakland (BCHO). Thus, BCHSF and BCHO, along with UCLA, will comprise a clinical consortium or hub site in the present site application. We will work closely with our ancillary site, University of California, Davis Children’s Hospital. In combination with this partner, our site will provide access to 104 PICU beds with approximately 4500 annual admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced MODS” trial described in the Overall Component of this application. Our site proposal has three specific aims: Specific Aim 1. Actively collaborate in implementation of CPCCRN, including participation on the Steering Committee and other committees, attendance at meetings, facilitating contracting with the Data Coordinating Center, and complying with the standard operating procedures and performance expectations of the network. Specific Aim 2. Provide opportunities for young investigators to participate in CPCCRN meetings, committees, or trial implementation, with the goal of developing these talented individuals into fundable clinician scientists. Specific Aim 3. Implement the Personalized Immunomodulation in Sepsis-induced MODS trial, including enrollment of patients by trained research staff, adhering to the study protocol, prompt data entry, and full compliance with Good Clinical Practice (GCP) and other regulatory requirements.