Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2005
[Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].
Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2005
[Clinical trials in Germany and in the EU in the new legislative environment. An analysis from the industry's point of view].
The European Union's (EU) Directive 2001/20/EC and its accompanying directives and guidance aim at approximating laws, regulations and administrative provisions relating to the implementation of Good Clinical Practice and Good Manufacturing Practice in the conduct of clinical trials on investigational medicinal products for human use in the EU member states. In addition, the establishment of two European databases for collecting information on clinical trials and suspected unexpected serious adverse events, respectively, should increase the transparency of clinical trials in the EU and thus improve patient safety. ⋯ There is the hope that patient safety will be improved by these measures. The future task of all involved stakeholders will be to work on a harmonisation of the different requirements in order to achieve the original goals intended by the Directive 2001/20/EC.