Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Feb 2005
Practice Guideline Guideline[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].
Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. ⋯ Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Feb 2005
Practice Guideline Guideline[Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].
In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Feb 2005
[Clinical guidelines. What do doctors and patients get from them].
Now more than ever physicians need effective management of the constantly increasing flood of medical information. The authors discuss possibilities for developing clinical guidelines as a core element of this information management and the requirements of these possibilities. The development of clinical guidelines is a process also suitable for involving patient and consumer expertise in health care. Models of involving patients are described and how these processes can build an important base for shared decision making of physicians and patients.