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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.

Spain
Spain is divided into 17 autonomous communities, many of which have their own laws and regulations pertaining to drug research and privacy/data protection

Legislations
  1. Oviedo Convention on Human Rights and Biomedicine (1999)
  2. Law 14/2007 on Biomedical Research
  3. Royal Decree 223/2004: Regulation of Medication Clinical Trials (Spanish)
  4. Organic Law 15/1999 of December 13 on the Protection of Personal Data
  5. Law 14/2007 on Biomedical Research, Title I, Article 5

Regulations
  1. Order SCO/256/2007 That Establishes the Principles and Detailed Directives on Good Clinical Practice, and the Requirements to Approve the Manufacture and Import of Research Medications for Human Use (Spanish)
  2. Order SCO/362/2008 that Modifies Order SCO/256/2007 (Spanish)
 
 


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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