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    Links
    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)