HEAL Sickle Cell and CDE Supplement

摘要 美国国立卫生研究院创建了帮助结束成瘾长期(Hear)倡议，以加快科学解决方案 国家阿片类药物公共卫生危机。作为Hear倡议的一部分，RFA-AT-23-002 Hear Initiative：镰刀细胞 利用疼痛管理有效性研究网络合作社进行的疾病疼痛管理试验 协议(UG3/UH3，需要临床试验)已经公布；预计将选出两个奖项 通过NIH治愈疼痛管理有效性研究网络(ERN)进行试验。两次审判 将由不同的机制管理。将管理第一次试验(在此称为初级试验) 类似于正在进行的五项Heave ERN试验。三个Hear ERN资源中心将作为一个综合的 提供临床协调中心(CCC)支持(杜克/范德比尔特)、数据协调中心的基础设施 (DCC)支持(犹他州)和生物统计支持(霍普金斯/塔夫茨)。第二次审判(本文中称为 第二次试验)将由犹他大学管理，以获得CCC和DCC的支持。犹他州的这两项试验 将提供单一机构审查委员会(SIRB)服务。除了镰刀细胞试验，这份补充材料 还包括犹他州对Hear Common Data Elements(CDE)计划的一年支持。迄今为止的努力 由国家神经疾病研究所领导的专注于Hear疼痛手臂的CDE计划 和中风(NINDS)。国家药物滥用研究所(NIDA)领导着阿片类药物部门，该部门正在开始CDE 努力。此CDE补充请求涵盖由大学的Hear CDE团队执行的工作 并支持三项主要活动：(1)CDE文档准备(NINDS)，(2)治愈CDE计划 行政操作(NINDS)，以及(3)OUD研究使用的工具调查(NIDA)。这所大学 犹他州Hear ERN资源中心正在申请行政补充，以支持NIH 如上所述，治愈主动性。该补编将支持以下具体目标： 具体目标1.为初级镰状细胞试验提供数据协调中心支持，与其他机构合作 ERN资源中心的方式与目前的五个ERN试验相同，详见父母赠款。 具体目标2.为次级镰状细胞提供全面的临床和协调中心支持 审判。 具体目标3.通过(1)CDE文件准备，(2)Hear CDE计划支持Hear CDE项目 行政操作；(3)OUD研究工具的调查。

Abstract The NIH has created the Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. As part of the HEAL initiative, RFA-AT-23-002 HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required) was posted; and it is anticipated that two awards will be selected to conduct trials through the NIH HEAL Pain Management Effectiveness Research Network (ERN). The two trials will be managed by different mechanisms. The first trial (herein referred to as the primary trial) will be managed similarly to the five ongoing HEAL ERN trials. The three HEAL ERN resource centers will function as an integrated infrastructure to provide clinical coordinating center (CCC) support (Duke/Vanderbilt), data coordinating center (DCC) support (Utah), and biostatistics support (Hopkins/Tufts). The second trial (herein referred to as the secondary trial) will be managed by the University of Utah for both CCC and DCC support. For both trials Utah will provide single institutional review board (sIRB) services. In addition to the Sickle Cell trials, this supplement also covers Utah support for the HEAL Common Data Elements (CDE) Program for one year. Efforts to date on the CDE Program focused on the pain arm of HEAL, led by the National Institute of Neurological Disorders and Stroke (NINDS). The National Institute on Drug Abuse (NIDA) leads the Opioid arm, which is beginning CDE efforts. This CDE supplement request covers work to be performed by the HEAL CDE team at the University of Utah, and supports three main activities: (1) CDE document preparation (NINDS), (2) HEAL CDE program administrative operations (NINDS), and (3) Survey of instruments used by OUD studies (NIDA). The University of Utah HEAL ERN Resource Center is requesting an administrative supplement to enable support of the NIH HEAL initiative as described above. The supplement will support the following specific aims: Specific Aim 1. Provide data coordinating center support for the primary sickle cell trial, working with the other ERN Resource Centers in the same manner as the current five ERN trials, as detailed in the parent grant. Specific Aim 2. Provide comprehensive clinical and coordinating center support for the secondary sickle cell trial. Specific Aim 3. Support the HEAL CDE Project through (1) CDE document preparation, (2) HEAL CDE program administrative operations, and (3) survey of instruments used for OUD studies.