Good clinical practice: Historical background and key aspects

Andreas Otte, Herbert Maier-Lenz, Rudi A. Dierckx

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    19 Citations (Scopus)

    Abstract

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

    Original languageEnglish
    Pages (from-to)563-574
    Number of pages12
    JournalNuclear Medicine Communications
    Volume26
    Issue number7
    Publication statusPublished - Jul-2005

    Keywords

    • good clinical practice (GCP)
    • Food and Drug Administration (FDA)
    • Declaration of Helsinki
    • Council for International Organizations of Medical Sciences (CIOMS)
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • (ICH)
    • European Medicines Evaluation Agency (EMEA)
    • EU Clinical Trial Directive

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