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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.

Czech Republic


  1. Act No. 20/1996 on the Care for the Health of People
  2. Oviedo Convention on Human Rights and Biomedicine (2001)
  3. Act No. 130/2002 Collection on the Research and Development Support as Amended
  4. Act No. 378/2007 Collection on Pharmaceuticals
  5. Act on the Protection of Personal Data and on Amendment to Some Related Acts (No. 101 of April 4, 2000)


  1. MOH: Decree No. 226/2008 on Good Clinical Practices and on Detailed Conditions for Evaluation of Pharmaceutical Products
  2. Position No. 3/2004 Personal Data Processing in the Context of Clinical Testing of Drugs and Other Medical Substances

Guidelines (SUKL):

  1. KHL-8: Clinical Trial Protocol and Protocol Amendments (1998)
  2. KLH-10: Terminology and Principles of Good Clinical Practice (1998)
  3. KLH-11: Ethics Committees (1998)
  4. KLH-19: Documentation Required for an Approval of a Clinical Trial on a Human Pharmaceutical (2001)
  5. KLH-20: Application for Approval/ Notification of a Clinical Trial (2004)

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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