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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)

Den Nationale Videnskabsetiske Komité (Danish National Committee on Biomedical Research Ethics)