Setting up clinical research studies in the National Health Service in England
Setting up clinical research studies in the National Health Service in England
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在英国国家医疗服务体系中开展临床研究
DOI：
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
P. Sooriakumaran
中科院分区：
文献类型：
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作者：
J. Whitburn;Surjeet Singh;P. Sooriakumaran
在英国开始和进行临床试验可能是一个复杂且耗时的过程。在您的研究开始之前，必须获得相应监管机构的批准。在2016年3月之前，研究需要通过国家卫生研究所（NIHR）协调系统获得国家卫生服务（NHS）许可（也称为研发（R&D）批准）才能获得NHS许可（CSP）。自2016年3月以来，引入了一个新的简化系统，旨在更容易获得监管批准。现在，研究必须经过健康研究管理局（HRA）的批准。在这篇文章中，我们回顾了在英国获得HRA批准的过程。这篇文章针对的是初级研究人员，帮助他们了解申请过程，并提供如何成功获得批准的提示。
Starting and conducting clinical trials in England can be a complicated and time-consuming process. Before your study can begin it is necessary to gain approval from the appropriate regulatory bodies. Prior to March 2016, studies required National Health Service (NHS) permission (also referred to as Research and Development (R&D) approval) obtained via the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP). Since March 2016, a new streamlined system has been introduced with the aim of making it easier to gain regulatory approvals. Now studies must go through the process of Health Research Authority (HRA) approval. In this article we review the process of gaining HRA approval in England. The article is aimed at junior researchers to help them understand the application process, and to give tips on how to succeed in gaining approval.