Categories


  • Archives

    Good Clinical Practice Training at NCRC – UPDATE June 2019


    The National Children’s Research Centre based at Children’s Health Ireland at Crumlin, delivers ‘Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP)’ and ‘Paediatric Good Clinical Practice (GCP) Refresher’ training courses for Investigators and associated research site personnel.

    The one day introductory course is relevant to Principal Investigators, research nurses and associated research site personnel who have not previously undertaken GCP training. The half day refresher course is relevant to Principal Investigators, research nurses and associated research site personnel who have not undertaken GCP training within the previous 2 years.

    The following content is included:

    • Introduction to Paediatric Drug Development and Clinical Research;
    • Research Ethics and Research Governance;
    • Principles of ICH-GCP (including integrated addendum E6 (R2));
    • Investigator Responsibilities;
    • Essential Documents;
    • Regulatory Inspections.

    Both courses include practical workshops and opportunities for discussion.

    Scheduled dates for 2019

    Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP) – Full day course

    • 10th April 2019
    • 12th June 2019
    • 27th September 2019

    Paediatric Good Clinical Practice (GCP) Refresher – Half day course

    • 17th July 2019
    • 29th November 2019

    Both courses are accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs and 3 CEUs, respectively. They also meet the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma as necessary to enable mutual recognition of GCP training among trial sponsors.

    For further information, or to book a place on one of the upcoming courses, please contact gcptraining@ncrc.ie.

    NCRC Paediatric Clinical Research and GCP Training Course Poster 2019


    Topics


    Archives