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
Grade: Core Library
Description
- 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.
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.
Keywords
- Clinical Trials
- Clinical Trial Protocol
- Good Clinical Practice (GCP)
- Human Subjects
- ICH GCP
- Independent Ethics Committee (IEC)
- Institutional Review Board (IRB)
- Informed Consent
- Regulatory Authorities
- Sponsors
- Trial Safety and Welfare
Module Features
Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen