[公共药物临床试验规范单位——奥胡斯大学医院的经验]

[Public GCP unit--experiences from the Aarhus University Hospital].

作者信息

Jørgensen Annette, Rønnow Inge-Lise Hassing, Nexø Ebba

机构信息

GCP-enheden ved Arhus Universitetshospital, Bygning 1, Arhus Kommunehospital, Nørrebrogade 44, DK-8000 Arhus C.

出版信息

Ugeskr Laeger. 2003 Apr 14;165(16):1667-9.

PMID:12756826

Abstract

According to the EU GCP-directive, all clinical trials involving medical products must adhere to the GCP-standards by May 2004. This may entail difficulties for investigator-initiated trials not sponsored by the industry. A public GCP-unit was established at Aarhus University Hospital in 1995. The unit offers researchers a monitoring system including discussion of the protocol, check of formalities, and verification of data and protocol compliance. As a contribution to the future work with GCP, experience from the GCP-unit at Aarhus University Hospital is presented here.

摘要

根据欧盟药品临床试验规范指令，所有涉及医疗产品的临床试验必须在2004年5月前遵守药品临床试验规范标准。这可能给非行业赞助的研究者发起的试验带来困难。1995年在奥胡斯大学医院设立了一个公共药品临床试验规范单位。该单位为研究人员提供一个监测系统，包括讨论试验方案、检查手续以及核查数据和试验方案的合规情况。作为对药品临床试验规范未来工作的贡献，本文介绍了奥胡斯大学医院药品临床试验规范单位的经验。