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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.
Ukraine

Legislations

  1. On Medicines, Articles 7 and 8 No. 123/96ВР (1996)
  2. Information Act from the Cabinet of Ministers of the Ukraine (2002)


Regulations

  1. EC-HEC: Order of this Committee for Requirements of Ethical Review of All Dissertation Theses on Science, Degree in Biology, Medicine, and Veterinary Medicine (2005)
  2. MOH:Order No. 485 About Creation and Composition of Central Ethics Committee of Ministry of Health of the Ukraine (2006) (Ukrainian)
  3. MOH:Order No. 142 About Optimization of Work of Central Ethics Committee of Ministry of Health of the Ukraine (2007) (Ukrainian)
  4. Ukrainian Ministry of Health Decree No. 373 About Approval of Documents Related to the Standardization, Registration and Conduct of Clinical Trials of Study Drugs 42-7.0:2005 (2005)
  5. Ukrainian Ministry of Health Order No. 66 About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committee (2006)


Guidelines
MOH Central Ethics Committee:

  1. Information Letters on Ethics Questions of Clinical Trials and Implementation of Medicines (2006)
  2. Ethics Expertise of Clinical Trials Medicines (2007)
  3. Methodological Aspects of Central EC Activity of Ukrainian Ministry of Health (2007)
  		 


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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