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实施 EQIPD 质量体系。

Implementation of the EQIPD Quality System.

机构信息

Guarantors of EQIPD e.V., Heidelberg, Germany; PAASP GmbH, Heidelberg, Germany; Institute for Psychopharmacology, Central Institute of Mental Health, Mannheim, Germany.

Institute for Psychopharmacology, Central Institute of Mental Health, Mannheim, Germany.

出版信息

J Neurosci Methods. 2024 May;405:110084. doi: 10.1016/j.jneumeth.2024.110084. Epub 2024 Feb 23.

Abstract

The EQIPD Quality System (QS) was conceptualized and established by an international consortium consisting of academic and industrial partners to ensure that non-regulated biomedical research will be conducted according to Good Research Practice expectations. The QS supports researchers to reflect on and improve internal practices by providing a systematic framework and guidance for implementing the EQIPD QS in a time and cost effective manner. This report describes the content of the EQIPD QS with its key features and 18 Core Requirements (CR) in more detail. It gives a short background on each CR and hands on examples on how they were addressed by two different research labs in their respective laboratory environments. Thereby, this article provides examples and direction for other research labs who aim to implement the QS as well. The final paragraphs discuss the potential benefits of the QS in respect to different user groups and stakeholders within the scientific community and summarize the overall governance structure of the EQIPD framework.

摘要

EQIPD 质量体系(QS)由一个由学术和工业合作伙伴组成的国际联盟构思和建立,以确保不受监管的生物医学研究将按照良好研究实践的期望进行。QS 通过为在时间和成本效益上实施 EQIPD QS 提供一个系统的框架和指导,支持研究人员反思和改进内部实践。本报告更详细地描述了 EQIPD QS 的内容及其关键特征和 18 项核心要求(CR)。它简要介绍了每个 CR 的背景,并举例说明了两个不同的研究实验室如何在各自的实验室环境中解决这些问题。因此,本文为其他希望实施 QS 的研究实验室提供了示例和指导。最后几段讨论了 QS 对科学界不同用户群体和利益相关者的潜在好处,并总结了 EQIPD 框架的总体治理结构。

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