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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Turkey
Legislations
  1. Turkish Constitution, Article 17
  2. Health Services Basic Law No. 3359 (1987)
  3. Oviedo Convention on Human Rights and Biomedicine (2004)
  4. Turkish Penal Law, Article 90 (2005)
Regulations
  1. Regulation on Medical Deontology, Article 11 (1960)
  2. Regulation on Medical Research (1993)
  3. Bylaw on Patient Rights No. 23420 (1998)
  4. Regulation on Drug Research in Turkey (1993)
  5. Bylaw on the Clinical Trials Conducted by Medical Products Used in Humans (1993)
  6. Bylaw on the Evaluation and Monitoring of the Safety of Medical Products (2005)
  7. Regulation Regarding the Implementation and Inspection of the Support for Research and Development Activities (2008)
Guidelines
  1. Guideline of Good Clinical Practice (1995)
  2. Guideline of Compassionate Use of Experimental Drugs (2006)
  3. Guidance on Observational Studies Performed with Drugs (2008)
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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