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...
About
The Principal Investigator & Site Leadership Learning Path is designed to equip Principal Investigators (PIs), Sub-Investigators, and clinical site leadership teams with the knowledge and responsibilities required to effectively lead and oversee clinical trials. This comprehensive programme covers ICH GCP E6(R3) requirements, investigator responsibilities, informed consent, protocol compliance, patient safety oversight, site management, documentation standards, inspection readiness, and leadership best practices for clinical research sites.
The learning path focuses on strengthening regulatory compliance, ethical decision-making, data integrity, and effective communication between sponsors, CROs, and site teams to support high-quality, inspection-ready clinical trial conduct. Ideal for both new and experienced investigators, the programme provides practical insights into managing research teams, ensuring participant protection, and maintaining oversight throughout the clinical trial lifecycle.
Courses Included

Understand the key responsibilities of Principal Investigators in ensuring ethical, compliant, and high-quality clinical trial conduct.

Learn the ethical and regulatory requirements for obtaining and documenting informed consent in clinical trials.

Gain an understanding of Quality Management System principles and their application within clinical research sites.

Prepare for clinical trial audits by learning best practices for compliance, documentation, and inspection readiness.

Understand GDPR requirements and data privacy obligations within pharmaceutical and clinical research environments.

Learn the principles and requirements of ISO 14155:2026 for conducting compliant and ethical medical device clinical investigations.
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Frequently Asked Questions
- Principal Investigators (PIs)
- Sub-Investigators and Co-InvestigatorsClinical Trial Site Leaders and Site Managers
- Clinical Research Coordinators and Site Staff
- Physicians and Healthcare Professionals involved in clinical research
- Research Nurses and Allied Healthcare Professionals
- Site teams preparing for regulatory inspections or sponsor audits
Upon completion of this learning path, participants will be able to effectively fulfil investigator and site leadership responsibilities, ensure compliance with ICH GCP E6(R3) requirements, oversee informed consent and participant safety, maintain inspection-ready documentation, manage clinical trial site operations, and support high-quality, ethical, and compliant clinical research conduct.


