GCP Essential Documents: Investigators Brochure & Study Protocol

• 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

Learner Benefits:

• Gain a Clear Understanding of Key Clinical Trial Documents: Develop a comprehensive understanding of the Investigator’s Brochure (IB) and Study Protocol, including their purposes, essential components, and alignment with ICH E6 guidelines.

• Gain Insight into the Recommended Sections for Essential Documents: Know the critical sections to include in the Investigator’s Brochure and Study Protocol, ensuring effective trial management and regulatory compliance.

• Enhance Communication Skills Through Documentation: Understand how clear and accurate documentation facilitates effective communication of complex trial information to diverse audiences, including non-scientific stakeholders.

• Improve Compliance and Trial Integrity: Gain insights into best practices for documentation to meet regulatory requirements, reduce errors, and support the integrity and success of clinical trials.

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