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International Conference on Harmonisation (ICH E-6 4.8.9).pdf

THE PRINCIPLES OF ICH GCP ... Monitoring Committee .....25 5.6 Investigator Selection ... Good clinical practice (GCP) ...  

ICH Guideline for Good Clinical Practice E6(R1).pdf

GUIDELINE FOR GOOD CLINICAL PRACTICE ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting ...  

1. ICH GCP Monitoring Requirements.pdf

Guideline for Ruth Ann Nylen’s Teleseminar on Monitoring Visit Preparation. Listen to Seminar Here (b) Reports should include the date, site, name of the monitor ...   Down

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  • 1. ICH GCP Monitoring Requirements

    Guideline for Ruth Ann Nylen’s Teleseminar on Monitoring Visit Preparation. Listen to Seminar Here (b) Reports should include the date, site, name of the monitor ...

    www.ruthannnylen.upcsites.org/f/ICHGCPMonitoringRequirements2.pdf
  • ICH HARMONISED TRIPARTITE GUIDELINE

    STATISTICAL PRINCIPLES FOR CLINICAL TRIALS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting

    www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/...
  • ISO14155 & ICH GCP The differences & similarities …

    Background ICH GCP • Joint initiative - regulators and pharmaceutical industry • Goal - harmonize requirements in order to aid global drug development

    www.icr-global.org/EasysiteWeb/getresource.axd?AssetID=11076&type=...
  • ICH GCP Guidelines The Sponsor - MD Anderson

    ICH GCP Guidelines The Sponsor Marsha Hofweber, BSN, RN, CCRP Clinical Research Support Center

    www.mdanderson.org/.../6.-sponsor-and-ich-gcp-guidelines.pdf