Skip to content

Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.


Get In Touch

    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:


    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:

       Voice Over
        Knowledge Checks
       SCORM/AICC compatible
        Full Screen


    Clinical Trial
    Essential Documents
    ICH E6
    Investigator’s Brochure
    Protocol Amendment
    Regulatory Authority
    Study Protocol
    Back To Top