Jørgensen Annette, Bach Karin Friis, Friis Karen
Basic Clin Pharmacol Toxicol. 2004 Feb;94(2):57-8. doi: 10.1111/j.1742-7843.2004.pto940201.x.
By May 2004, all clinical trials in the European Union (EU) on medicinal products have to be initiated and conducted in compliance with the principles in the new directive on Good Clinical Practice (GCP). This requirement will also apply to non-commercial trials involving registered drugs and may therefore restrain the academic clinical drug research. In Denmark, three public GCP units connected in a national network and associated with the university hospitals in Copenhagen, Odense and Aarhus have been established. The GCP units offer academic researchers the necessary quality assurance and quality control systems to ensure that clinical drug research can be performed according to GCP. The Danish initiative is presented here as a contribution to the future work with implementation of the principles of GCP in academic clinical drug research in the European Union.
到2004年5月，欧盟（EU）境内所有药品临床试验都必须依据新的《药物临床试验质量管理规范》（GCP）指令中的原则启动并实施。这一要求也将适用于涉及已注册药物的非商业性试验，因此可能会限制学术性临床药物研究。在丹麦，已设立了三个公共GCP单位，它们组成了一个全国性网络，并与哥本哈根、欧登塞和奥胡斯的大学医院相关联。这些GCP单位为学术研究人员提供必要的质量保证和质量控制体系，以确保能够按照GCP开展临床药物研究。本文介绍丹麦的这一举措，旨在为欧盟学术性临床药物研究中实施GCP原则的未来工作做出贡献。
