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Guidance for Industry - Food and Drug Administration.pdf

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance Additional copies are available from: the Drug Information Branch (HFD-210), ...  

GUIDELINE FOR GOOD CLINICAL PRACTICE - ICH Official.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

Extracted from ICH GCP Guideline Section 5.18 Monitoring 5.18.4 Monitor’s Responsibilities. The monitor(s), in accordance with the sponsor’s requirements, ...   Down

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  • 1. ICH GCP Monitoring Requirements

    Extracted from ICH GCP Guideline Section 5.18 Monitoring 5.18.4 Monitor’s Responsibilities. The monitor(s), in accordance with the sponsor’s requirements, ...

    www.ruthannnylen.upcsites.org/f/ICHGCPMonitoringRequirements2.pdf
  • ICH GCP Essential Document Checklist - Welcome to URMC

    ICH GCP Essential Document Checklist ... 5.5.2 Data Safety Monitoring Plan (if applicable)

    www.urmc.rochester.edu/ctsi/score/events/documents/ICHGCPEssential...
  • 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/...
  • 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