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Q of the week

Q: Do clinical trials ever go wrong?

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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. Law No. 26.027 (2005)
  2. Law for the Protection of Private Life No. 19.628 (1999) (Spanish)


  1. Supreme Decree No. 42 (1986)
  2. Supreme Decree No. 1.935 (1993)
  3. General Technical Rule No. 2 of the Ministry of Health (1993)
  4. Exemption Resolution No. 134 (1994)
  5. Supreme Decree No. 494 (1999)
  6. Exemption Resolution No. 1.856 (1999)
  7. Resolution No. 2.085 of the Ministry of Health (2001)
  8. Technical Rule No. 57: Regulation of the Conduct of Clinical Trials that Use Pharmaceutical Products in Human Beings (2001)


  1. Ethical Guidelines for Clinical Trials with Pharmaceutical and Biological Products (2001)

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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