Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.
Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.
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DOI：
10.1017/cts.2022.391
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发表时间：
2022
影响因子：
2.6
通讯作者：
Bernard, Gordon R.
中科院分区：
文献类型：
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作者：
Johnson, Ann R.;Singleton, Megan Kasimatis;Ozier, Julie;Serdoz, Emily;Beadles, Jennifer G.;Maddox-Regis, Janelle;Mumford, Sarah;Burr, Jeri;Dean, J. Michael;Ford, Daniel E.;Bernard, Gordon R.
试验创新网络已经建立了一个基础设施，用于响应联邦政策的单一IRB审查。该网络的单一IRB（sIRB）通过800多个依赖安排成功支持了70多项多中心研究。这产生了一些经验教训，可以使国家临床研究企业受益，因为我们正在努力改善临床试验的进行。这些经验教训包括区分单个IRB与机构人类研究保护计划的角色，建立一致的sIRB审查模型，标准化收集当地背景和补充研究特定信息，以及教育和授权领导研究团队支持其研究中心。
The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.
影响因子：
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作者：
Klitzman, Robert;Pivovarova, Ekaterina;Lidz, Charles W
通讯作者：
Lidz, Charles W
影响因子：
1.5
作者：
Hahn, Cynthia;Kaufmann, Petra;Calvert, Sara
通讯作者：
Calvert, Sara
影响因子：
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作者：
Taylor, Holly A;Ehrhardt, Stephan;Ervin, Ann-Margret
通讯作者：
Ervin, Ann-Margret