Clinical drug trials from the Public Law perspective
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Abstract (EN)
The subject of our thesis is ?Clinical Drug Trials From the Public Law Perspective?. Our thesis consists of three parts. In the first part, main concepts related to the subject of the thesis are introduced. ?Clinical drug trial? is a kind of medical research on humas. Therefore, first of all, the concept of ?medical research on humans? and a brief history of medical research on humans are explained. Then, concepts of ?drug? and ?clinical drug trial?, the historical development of clinical drug trials, basic international documents related to clinical trials and the relevant legislation in the Turkish Law are examined. Moreover, the importance of clinical drug trials, the role of the state in clinical drug trials and the legal character (nature) of clinical drug trial are discussed. The importance of the subject from the Administrative Law perspective is emphasized. Finally in this part, the classification and the phases of clinical drug trials are examined.In the second part, the basic principles related to clinical drug trials are discussed in the light of relevant international documents. Then, the rights of human subjects in clinical drug trials are examined in terms of these principles. Furthermore, the conditions of clinical drug trial are explained in detail.In the third and the last part, the internal control conducted by the sponsor, supervision by the administrative government and the judicial review are explained. Moreover, the insurance for the research subjects in clinical drug trials is explained in detail. Finally, the liability of the administrative government is discussed for the damages (harms) of research subjects which are out of the insurance coverage and which are can not reimbursed from the insurance.
Author
Makbule Mine Turhan
Institution
How to Cite
Makbule Mine Turhan (Doctorate thesis). Clinical drug trials from the Public Law perspective, 2010, Dokuz Eylül University.
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