JHU Statistical and Safety Resource Center (SSRC)

摘要 JHU SSRC是一个由多中心试验PI组成的成熟的职能团队，经验丰富， 领导者、行政人员和科学家。BIOS，JHU临床试验协调 中心，将在运作上召集这个小组，并提供工作人员执行所需的 统计和安全资源中心计划及其在 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审判远远超出了过去五年的工作范围 正在进行的HEAL Pain ERN研究中，我们的团队担任了临床 数十个大型多中心的协调中心和数据协调中心 在不同的NIH IC进行临床试验。与我们在杜克、犹他州和 范德比尔特，我们将支持获奖团队的新镰状细胞试验在同一时间， 合作和全面的方式，已被证明为正在进行的 目前作为治愈疼痛ERN倡议的一部分授予的五项试验。

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.