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Clara Fargo
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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
GCP for Principal Investigators Course & Certification
Intermediate
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4.7
★★★★★
96% Recommended
Updated 2026
2 hour
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1 x GCP for Principal Investigators
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Each course includes:
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
Fully compliant
This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
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About
The GCP Principal Investigators Course is designed to provide a comprehensive understanding of the roles, responsibilities, and regulatory obligations of Principal Investigators in clinical trials. It focuses on ensuring ethical conduct, participant safety, protocol adherence, and high-quality data generation in compliance with Good Clinical Practice (GCP) guidelines.
This course covers key investigator responsibilities including trial oversight, informed consent, delegation of duties, safety reporting, protocol compliance, and communication with sponsors and ethics committees. It also emphasizes inspection readiness, risk-based quality management, and documentation practices required for successful clinical trial conduct. Upon completion, learners receive a certification demonstrating their competency in GCP-compliant investigator responsibilities.
Who Should Enrol?
- Principal Investigators (PIs)
- Sub-Investigators (Sub-Is)
- Physicians involved in clinical research
- Clinical Research Coordinators (CRCs)
- Site study staff and research nurses
- Academic and hospital-based researchers
- Healthcare professionals participating in clinical trials
What you will learn
Understand the fundamentals of ICH GCP (E6 R3), including its principles, document structure, quality concepts, and regulatory expectations for Principal Investigators.
Gain clarity on regulatory authority and IEC/IRB requirements, informed consent ethics, inspection readiness, and the PI’s accountability in protecting participant safety.
Develop strong knowledge of investigator responsibilities, including protocol compliance, IMP management, delegation, documentation, safety reporting, and medical oversight.
Strengthen practical competency in informed consent, clinical trial protocol adherence, monitoring interactions, electronic systems, RBQM, and inspection-ready site management.
Course Syllabus
- The History & Origins of GCP
- The 11 Principles of ICH GCP
- GCP Document Structure & Version Control
- Core Quality Concepts in E6(R3)
- Regulatory Authorities
- The Independent Ethics Committee
- Informed Consent from an Ethics Perspective
- Inspection Readiness
- The PI's Role —Authority, Accountability & Delegation
- Qualifications, Resources & Medical Care
- Protocol Compliance & IMP Management
- Record-Keeping, Reporting & Safety
- Informed Consent — Core Principles
- Special Consent Situations
- The Clinical Trial Protocol
- The Monitor's Role in Clinical Research
- What the Monitor Checks — Before, During & After
- CRF Completion, Data Quality & Audit Trails
- Close-Out & Post-Trial Monitoring
- Business Continuity Planning for Clinical Sites
- The Monitor's Role in Clinical Research
- What the Monitor Checks — Before, During & After
- CRF Completion, Data Quality & Audit Trails
- Close-Out & Post-Trial Monitoring
- Business Continuity Planning for Clinical Sites
- Electronic Systems in Clinical Trials
- Risk-Based Quality Management
- Inspection Readiness & Essential Records
- Close-Out & Post-Trial Monitoring
- Business Continuity Planning for Clinical Sites
- Ethics, Safeguards & PI Responsibility
- Sponsor Responsibilities
- Course Consolidation
- 📘 Bonus: GCP Principal Investigators eBook (Free with purchase)
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Frequently Asked Questions
This GCP Principal Investigator course provides a comprehensive understanding of the roles and responsibilities of a Principal Investigator (PI) in clinical research, in line with Good Clinical Practice (GCP) guidelines. It focuses on ensuring the safety, rights, and well-being of study participants while maintaining data integrity and regulatory compliance throughout the study lifecycle.
In this course, you will learn how to: Understand the responsibilities of a Principal Investigator under GCP
- Ensure participant safety, informed consent, and ethical conduct
- Maintain accurate and compliant study documentation
- Oversee study conduct, delegation, and site staff management
- Handle protocol adherence, deviations, and reporting requirements
- Prepare for audits, inspections, and monitoring visits
This course is ideal for individuals who want to begin or advance a career in clinical research, including:
- Aspiring Clinical Research Associates (CRAs)
- Clinical trial site staff transitioning into monitoring roles
- Clinical Research Coordinators (CRCs) seeking career progression
- Professionals working in pharmaceutical, biotech, or CRO environments
- Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
- Industry-aligned training with global recognition
- Fully updated to ICH GCP E6 (R3) requirements
- Strengthen understanding of PI responsibilities under GCP
- Practical, scenario-based learning to build real-world confidence
- Certificate issued upon successful completion
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