JHU Statistical and Safety Resource Center (SSRC)

摘要 JHU SSRC 是一个成熟的、运作良好的多中心试验 PI 团队，他们经验丰富 首席经理、行政人员和科学家。 BIOS，JHU 临床试验协调机构 中心，将在运作上召集该小组并提供工作人员执行所需的工作 统计和安全资源中心计划及其具体分配的任务 统计、安全和 DSMB 管理领域。我们共同的专业知识，开发和 管理这些特定领域的试验远远超出了过去五年的工作范围 正在进行的 HEAL Pain ERN 研究，我们的团队担任临床 数十个大型多中心的协调中心和数据协调中心 各个 NIH IC 的临床试验。与我们在犹他州杜克大学的合作伙伴一起， 范德比尔特，我们将支持获奖团队在同一时间进行新的镰状细胞试验 已在正在进行的项目中展示了协作和全面的方式 作为 HEAL Pain ERN 计划的一部分，目前已授予五项试验。

ABSTRACT The JHU SSRC is an established, functioning team of multisite trial PIs, experienced lead managers, administrators, and scientists. BIOS, a JHU Clinical Trials Coordinating Center, will operationally convene this group and provide staff to execute the required Statistical and Safety Resource Center program and its specific assigned tasks in the areas of statistics, safety, and DSMB management. Our joint expertise, developing and managing trials in these specified areas extends well beyond the last five years of work on the ongoing HEAL Pain ERN studies with our group having served as clinical coordinating centers and data coordinating centers for dozens of large multi-centered clinical trials at various NIH ICs. Together with our partners at Duke, Utah, and Vanderbilt, we will support the awardee team for the new sickle cell trial in the same collaborative and comprehensive manner that has been demonstrated for the ongoing five trials currently awarded as part of the HEAL Pain ERN initiative.