HEAL ERN: Data Coordinating Resource Center

项目摘要 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Sciencefic解决方案的速度 国家阿片类公共卫生危机。作为Hear倡议的一部分，Hear有效性研究网络 (ERN)是为了进行预防和管理疼痛的比较有效性试验而设立的，而 降低上瘾的风险。在数据协调的支持下，已经实施了五项ERN试验 犹他大学试验创新中心。本建议书是为响应RFA-TR-22-012而编写的，旨在提供 继续支持这些fiVe试验，以及可能为响应RFA-AT-22而资助的另外两项试验- 005(《治愈倡议：利用疼痛管理有效性的镰状细胞病疼痛管理试验》) 研究网络合作协议“)。犹他州大学回应成为数据协调 资源中心(DCRC)。 我们将继续与每个ERN研究团队和其他Hear ERN资源合作 以1)开发、实施和监测ERN试验为中心；2)帮助应对下列问题/方案更改 在试验实施期间出现，并及时启动必要的更改，以确保试验成功；3)提供 收集和分析数据；以及4)协助及时公布研究结果。 我们的应用程序有三个特定的fic目标：1.与eRN调查人员和其他修复eRN资源 在研究和方案设计方面提供协作临床试验专业知识和协助的中心，单一的IRB， 研究实施和管理、受试者的应计费用、中期研究报告、fiNAL研究分析以及 协助及时出版和传播研究成果。2.提供全面的数据管理- 现有和新的ERN试验，包括数据库和数据收集系统、数据管理计划、 数据风险评估和质量控制，实施随机化，协助数据安全监控- ING Board(DSMB)报告，以及使用数据采集系统的培训。3.促进数据共享 通过将Hear通用数据元素(CDE)整合到协议中，继续支持Hear/ERN试验 NIH项目工作人员参与开发Hear CDE，继续参与Hear集体委员会，以及 准备适合存放在国家卫生研究院指定的存储库中的fiNAL数据集，以纳入到Hear中 数据生态系统。 我们与ERN调查人员的合作以及与其他资源中心的整合将使 成功和及时完成Hear ERN临床试验的可能性，导致研究成果的翻译 fi有助于有效治疗急性和慢性疼痛，同时最大限度地减少成瘾性阿片类药物的剂量规则。 男人们。

Project Summary The NIH 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, the HEAL Effectiveness Research Network (ERN) was established to conduct comparative effectiveness trials for prevention and management of pain, while reducing risk of addiction. Five ERN trials have been implemented with data coordination support from the University of Utah Trial Innovation Center. This proposal is written in response to RFA-TR-22-012 to provide continued support for these five trials, as well as two additional trials that may be funded in response to RFA-AT-22- 005 (“HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement”). The University of Utah is responding to be the Data Coordination Resource Center (DCRC). We will continue to work collaboratively with each ERN study team and the other HEAL ERN Resource Centers to 1) develop, implementand monitor the ERN trials; 2) help respond to issues/protocol changes that emerge during trial implementation and initiate timely necessary changes to assure trial success; 3) provide collection and analysis of data; and 4) assist with timely publication of study results. Our application has three Specific Aims: 1. Work with ERN investigators and other HEAL ERN Resource Centers to provide collaborative clinical trial expertise and assistance in study and protocol design, single IRB, study implementation and management, accrual of subjects, interim study reporting, final study analyses, and assistance with timely publication and dissemination of study results. 2. Provide comprehensive data manage- ment for current and new ERN trials, including database and data collection systems, data management plans, data risk assessment and quality control, implementation of randomization, assistance with Data Safety Monitor- ing Board (DSMB) reports, and training for using the data collection systems. 3. Facilitate sharing of data from HEAL/ERN trials by incorporating HEAL Common Data Elements(CDEs) into protocols, continuing to support NIH program staff in development of HEAL CDEs, continued participation in the HEAL Collective Board, and preparation of final data sets suitable for deposit in NIH-designated repositories for incorporation into the HEAL Data Ecosystem. Our collaboration with ERN investigators and integration with the other Resource Centers will maximize the likelihood of successful and timely completion of the HEAL ERN clinical trials, leading to translation of research findings to the effective management of acute and chronic pain, while minimizing addictive opioid dosing regi- mens.