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.)