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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.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins

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    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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