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.
Clinical Research
Below are useful ressources regarding clinical research.
General documents
WMA Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects)
ICH-GCP Guideline for Good Clinical Practice, ICH Topic E 6 (CPMP/ICH/135/95)
European
EMEA The European Agency for the Evaluation of Medical Products
EudraCT The European Clinical Trials Database
USA
FDA US Food and Drug Administration
OHRP Office for Human Research Protection, U.S. Department of Health and Human Services
Clinical Trials
International
ICH - 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)
National Videnskabsetisk Komité (Danish National Committee on Biomedical Research Ethics)