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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.
Venezuela

Legislations

  1. Constitution, Article 46 (Spanish)
  2. Medicines Act, Articles 72 and 73


Regulations

  1. Resolution No. 48 (1998)


Guidelines

  1. FONACIT: Code on Bioethics and Biosecurity (2002)
    IVIC:
  2. Annex 1: General Ethical Issues in Research Involving Living Persons
  3. Annex 2: Necessity of Establishing a Clear and Precise Study Protocol Before Starting Research
  4. Informed Consent
  		 


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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