Schwarz G
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Feb;48(2):181-8. doi: 10.1007/s00103-004-0976-3.
The new regulations on clinical trials with medicinal products for human use include rules for Good Clinical Practice (GCP) inspections. These rules pertain to such inspections as part of the surveillance program of the relevant state authorities, in preparation for a decision on the authorization of clinical trials by the federal authorities, and pre and post approval GCP-inspections as one tool of Good Regulatory Practice (GRP). The overall aim of such inspections is to verify compliance with the provisions on GCP and, thus, to ensure the protection of trial subjects, the credibility and reliability of clinical trial results, and the pro-active protection of patients. Since inspection results have to be acknowledged by other member states, there is an increasing importance for quality assurance and harmonization of inspection procedures. As in most cases a considerable number of sites are involved in the conduct of clinical trials in different member states, there is a need for coordination of GCP inspections between these states.
关于人用药品临床试验的新法规包括药品临床试验规范（GCP）检查规则。这些规则适用于作为相关国家当局监督计划一部分的此类检查，为联邦当局就临床试验授权做出决定做准备，以及作为良好监管规范（GRP）工具之一的批准前和批准后的GCP检查。此类检查的总体目标是核实是否符合GCP规定，从而确保保护试验受试者、临床试验结果的可信度和可靠性以及积极保护患者。由于检查结果必须得到其他成员国的认可，因此质量保证和检查程序的协调变得越来越重要。由于在大多数情况下，不同成员国进行的临床试验涉及大量试验地点，因此有必要在这些国家之间协调GCP检查。
