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Good clinical practice

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Handboek farmaceutische geneeskunde

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Inleiding

Klinisch geneesmiddelenonderzoek moet uitgevoerd worden volgens het strikte richtsnoer van good clinical practice (GCP). Dit is een internationale ethische en wetenschappelijke kwaliteitsstandaard voor het opzetten, uitvoeren, vastleggen en rapporteren van klinisch geneesmiddelenonderzoek waaraan proefpersonen deelnemen. In dit hoofdstuk beschrijven we de achtergronden, historie en de principes van GCP en bespreken we wie welke taken en verantwoordelijkheden heeft bij de uitvoering van geneesmiddelenonderzoek in overeenstemming met GCP.

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Notes

  1. 1.

    In Frankrijk is in 1987 de Loi Huriet ingevoerd. Deze wet stelt de taken en verplichtingen vast van partijen die onderzoek verrichten en uitvoeren. Deze wet kent al strafbepalingen voor het niet-naleven van de wettelijke vereisten.

  2. 2.

    Verzoek tot ontbinding arbeidsovereenkomst klokkenluider afgewezen. Conflict van plichten. Jurisprudentie Arbeidsrecht 25-02-2005, afl. 3, 257-263.

  3. 3.

    Deze voorbeelden zijn afkomstig van een door de US FDA gesponsorde website over dit onderwerp.

  4. 4.

    http://archief.nrc.nl/?modus=l&text=van+der+vring&hit=2&set=1 en

    http://www.amc.nl/web/Het-AMC/Agenda/Overzicht/Evenementen-overzicht/J.A.F.M.-van-der-Vring-Nchannel-calcium-blockade-in-coronary-artery-disease-and-congestive-heart-failure.htm.

  5. 5.

    De vigerende regels van good clinical practice staan beschreven in de tripartite guideline van de International Conference for the Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. 135/95/CPMP van juli 1996.

  6. 6.

    Op de website van de CCMO staat in detail beschreven welke documenten in welke vorm moeten worden ingediend bij een oordelende METC en de bevoegde instantie. Dit geldt voor zowel geneesmiddelenonderzoek als onderzoek met andere interventies zoals medische hulpmiddelen, chirurgische technieken en interventie-onderzoek waarbij een gedragswijze kan worden beïnvloed doordat bij de patiënt vragenlijsten worden afgenomen.

  7. 7.

    http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf.

  8. 8.

    http://ec.europa.eu/health/medical-devices/index_en.htm

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Author information

Authors and Affiliations

  1. specialisatie wet- en regelgeving klinische studies, Universiteit van Gent en consultant Profess Medical Consultancy B.V, Belgium, The Netherlands

    Herman Pieterse

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  1. Herman Pieterse
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Editor information

Editors and Affiliations

  1. Oss, The Netherlands

    Henk Jan Out

  2. BioClinica, Leiden, The Netherlands

    Paul van Meurs

  3. GlaxoSmithKline, Zeist, The Netherlands

    Rudolf van Olden

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© 2014 Bohn Stafleu van Loghum

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Pieterse, H. (2014). Good clinical practice. In: Out, H., van Meurs, P., van Olden, R. (eds) Handboek farmaceutische geneeskunde. Bohn Stafleu van Loghum, Houten. https://doi.org/10.1007/978-90-368-0265-9_8

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  • DOI: https://doi.org/10.1007/978-90-368-0265-9_8

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  • Print ISBN: 978-90-368-0264-2

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