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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.



  1. Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003)
  2. Keeping Research on Track: A guide for Aboriginal and Torres Strait Islander Peoples about Health Research Ethic (2006)
  3. National Statement on Ethical Conduct in Human Research (2007)
  4. Australian Code for the Responsible Conduct of Research (2007)
  5. Human Research Ethics Committees and the Therapeutic Goods Administration (2001)
  6. Australian Clinical Trial Hand Book (2006)

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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