Here you can find links to websites that are useful in the regulatory work related to the conduct of studies.
If you have suggestions for links to be added, please contact us.
Below are useful ressources regarding clinical research.
WMA Declaration of Helsinki
(Ethical Principles for Medical Research Involving Human Subjects)
Guideline for Good Clinical Practice, ICH Topic E 6 (CPMP/ICH/135/95)
The European Agency for the Evaluation of Medical Products
The European Clinical Trials Database
US Food and Drug Administration
Office for Human Research Protection, U.S. Department of Health and Human Services
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Danish Regulatory Authorities
Below are links to Danish Agencies in relation to clinical research:
Lægemiddelstyrelsen (Danish Medicines Agency)
Datatilsynet (Data Protection Agency)
Den Nationale Videnskabsetiske Komité (Danish National Committee on Biomedical Research Ethics)