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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.
Denmark

Legislations

  1. Oviedo Convention on Human Rights and Biomedicine (1999)
  2.  Act on the Biomedical Research Ethics Committee System (2003)
  3. Act Amending the Act on the Biomedical Research Ethics Committee System (2006)
  4. Medicinal Product Act No. 382 (2003)
  5. The Act on Processing of Personal Data (Act No. 429) (2007)


Regulations

  1. Ministerial Order No. 806 of 12 July 2004 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects (2004)
  2. Executive Order No. 935 on Informed Consent from Patients in Biomedical Trials (2000)
  3. Executive Order on Clinical Trials on Medicinal Products, Human Use (2004)
  4. Danish Guideline on Notification of Clinical Trials of Medicinal Products in Humans (2004)

  
Guidelines

  1. CVK: Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics (2008)
  2. Appendices (2008)
  3. DCE: Protection of Sensitive Personal Information
  4. Guideline on Informed Consent from Patients in Biomedical Trials (2000)
  		 


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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