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    GCP Essential Documents: Investigators Brochure & Study Protocol

    This Module is aimed at personnel in regulated industries who require an overview of two key documents used in a clinical trial – the Investigator’s Brochure and the Study Protocol. The purpose of each document is described along with recommended sections for inclusion according to ICH E6 guidelines.

      Duration: 30 Mins

    SKU: CGI-1202-SPL02-EN Category: Tag:

    Description

    Learning Objectives:

    • Explain why documentation is essential in clinical studies
    • Explain the purpose of an Investigator’s Brochure in a clinical trial
    • List the ICH recommended sections of an Investigator’s Brochure
    • Explain the purpose of a Study Protocol in a clinical trial
    • List the ICH recommended sections of a Study Protocol
    • Explain why clarity and conciseness are important in a Study Protocol
    • Define ‘Protocol Amendment’ and why it might be necessary
    Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

    Keywords

    Clinical Trial
    Essential Documents
    ICH E6
    IEC/IRB
    Investigator’s Brochure
    Protocol Amendment
    Regulatory Authority
    Study Protocol
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