合同研究机构层面优化监管体系的临床试验管理模式专家评价

Maria Yashchenko, Svitlana Bolman
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引用次数: 0

摘要

本研究在合同研究机构层面对优化监管制度的临床试验管理模式进行了专家评价。该模型是在关于监管制度对乌克兰临床试验管理的影响的论文研究中开发的。6位临床试验领域的专家(临床试验的监管、组织和执行)按照指南采用半结构化访谈法参与专家评估。本文介绍了在考虑专家意见的情况下,对合同研究机构层面优化监管制度适应临床试验管理模式的专家评价结果和结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
EXPERT EVALUATION OF THE CLINICAL TRIAL MANAGEMENT MODEL WITH AN OPTIMIZED REGULATORY SYSTEM AT THE LEVEL OF A CONTRACT RESEARCH ORGANIZATION
In this study, an expert evaluation of the clinical trial management model with an optimized regulatory system at the level of a contract research organization was conducted. The model was developed within the dissertation research regarding the impact of the regulatory system on the management of clinical trials in Ukraine. Six experts in the field of clinical trials (regulation, organization, and execution of clinical trials) were involved in the expert assessment using a semistructured interview method following the guide. The article presents the results of the expert evaluation and conclusions regarding the adaptation of clinical trial management model with an optimized regulatory system at the level of a contract research organization, considering expert opinions.
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