International Guidlines

 

Typically for a scientist the discovery and new insights in the focus. However, researchers need to consider additional guidelines, especially for research with humans.

Most important guidelines are :

  •      Helsinki Declaration of the World Medical Congress
  •      ICH Guidelines,
  •      National Drug and medical device laws
  •      National data protection guidelines
  •      Ethical requirements,
  •      Regulatory authorities (eg European EMEA, EFSA, or AGES)
  •      Statistical requirements in the planning stage (power calculation, sample size planning,
  •      etc.)
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