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About

This GCP for Principal Investigators Training course is aligned with globally recognized Good Clinical Practice standards and is widely applicable across pharmaceutical, biotechnology, and clinical research settings. The content reflects current regulatory frameworks, including ICH-GCP, FDA, and EU guidelines, supporting investigators in building a strong foundation in clinical trial oversight, ethics, and compliance.

PLEASE NOTE: while the curriculum aligns fully with TransCelerate BioPharma Inc. training standards, Whitehall Training cannot independently verify compliance if your previous GCP certification was obtained through another provider.

Course Syllabus

  1. The History & Origins of GCP
  2. The 11 Principles of ICH GCP​
  3. GCP Document Structure & Version Control
  4. Core Quality Concepts in E6(R3)

  1. Regulatory Authorities​
  2. The Independent Ethics Committee
  3. Informed Consent from an Ethics Perspective
  4. Inspection Readiness

  1. The PI's Role —Authority, Accountability & Delegation
  2. Qualifications, Resources & Medical Care
  3. Protocol Compliance & IMP Management
  4. Record-Keeping, Reporting & Safety

  1. Informed Consent — Core Principles
  2. Special Consent Situations
  3. The Clinical Trial Protocol

  1. The Monitor's Role in Clinical Research
  2. What the Monitor Checks — Before, During & After
  3. CRF Completion, Data Quality & Audit Trails
  4. Close-Out & Post-Trial Monitoring
  5. Business Continuity Planning for Clinical Sites

  1. The Monitor's Role in Clinical Research
  2. What the Monitor Checks — Before, During & After
  3. CRF Completion, Data Quality & Audit Trails
  4. Close-Out & Post-Trial Monitoring
  5. Business Continuity Planning for Clinical Sites

  1. Electronic Systems in Clinical Trials
  2. Risk-Based Quality Management
  3. Inspection Readiness & Essential Records
  4. Close-Out & Post-Trial Monitoring
  5. Business Continuity Planning for Clinical Sites

  1. Ethics, Safeguards & PI Responsibility
  2. Sponsor Responsibilities
  3. Course Consolidation

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

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...

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 .
No prior experience is required, but familiarity with clinical research or GCP is helpful.

  • 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