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Clinical trials of medicinal products on human subjects are a balancing act between the protection of the study participant and the preservation of his dignity on the one hand and the constant striving for medical progress on the other hand. This applies likewise to the control group as an essential part of every clinical testing of pharmaceuticals without which no drug will receive marketing authorisation in Germany by the competent authorities. Nevertheless, significant gaps in the German legislation concerning this matter still remain as the German legislator has yet to implement any specific rules with regard to the handling and management of the control group in clinical trials. In view of this unsettled legal situation, the author critically analyses the core of the problem areas in this field's current research practice and creates solutions reflecting the interests of the study participant as well as the practical needs of medical research. Only legal clarity regarding the control group can provide for the safety that is crucial in this field of tension between ethics, medicine and the law.

Drug testing.

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Drug testing

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Clinical trials of medicinal products on human subjects are a balancing act between the protection of the study participant and the preservation of his dignity on the one hand and the constant striving for medical progress on the other hand. This applies likewise to the control group as an essential part of every clinical testing of pharmaceuticals without which no drug will receive marketing authorisation in Germany by the competent authorities. Nevertheless, significant gaps in the German legislation concerning this matter still remain as the German legislator has yet to implement any specific rules with regard to the handling and management of the control group in clinical trials. In view of this unsettled legal situation, the author critically analyses the core of the problem areas in this field's current research practice and creates solutions reflecting the interests of the study participant as well as the practical needs of medical research. Only legal clarity regarding the control group can provide for the safety that is crucial in this field of tension between ethics, medicine and the law.

Drug testing.

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The field of quality assurance is beset by an extensive and sometimes confusing terminology, the use of which has still not been universally agreed on or accepted by laboratories or interested professional bodies worldwide. Several organizations have standardized the use of certain terms in an attempt to clarify their application. This glossary contains some of the most commonly used expressions in these fields, including those which appear in UNODC publications on quality assurance, and is an attempt to help promote and harmonize national efforts by providing internationally acceptable terminology. It is intended to be an aid to analysts in the implementation ofquality assurance programmes and good laboratory practices, and is provided to laboratories as an educational document, and as a means of encouraging laboratories to collaborate and participate in quality assurance matters. As a result, the Glossary includes more than one definition of a word or phrase where these might improve understanding of what they mean.

Drug Testing --- Medical --- Drug testing

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Drug courts --- Drug testing