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  • Preclinical & Laboratory Foundations
  • Phase I – First-in-Human Trials
  • Phase II & III – Efficacy & Pivotal Trials
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations - courses at £199
  • Good Laboratory Practice (GLP)
  • 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
  • OSHA Laboratory Safety Training
  • Laboratory Management Systems ISO/IEC 17025:2017
  • Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
  • Qualification Validation Training
  • Cleaning Validation
  • ISO 9001:2015 - Quality Management System for Pharmaceuticals

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.

Who Should Enrol?

  • Principal Investigators (PIs), Sub-Investigators, and Co-Investigators involved in clinical trial conduct.
  • Clinical Trial Site Leaders, Site Managers, Clinical Research Coordinators, and site staff.
  • Physicians, research nurses, and allied healthcare professionals participating in clinical research.
  • Site teams preparing for regulatory inspections, sponsor audits, and quality compliance reviews.

What you will learn

Understand the roles and responsibilities of Principal Investigators and site leadership in clinical trials, including ethical oversight and participant safety.

Learn how to ensure compliance with ICH-GCP E6(R3) guidelines, regulatory requirements, and sponsor expectations throughout study conduct.

Develop skills to manage informed consent processes, oversee protocol adherence, and maintain high standards of clinical trial documentation.

Gain practical knowledge in site operations management, inspection readiness, audit preparation, and maintaining quality in clinical research execution.

Courses Included

GCP for Principal Investigators

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

duration2 hoursCPD points2 points
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Informed Consent in Clinical Research

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

duration2 hoursCPD points3 points
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QMS Foundations for Clinical Sites

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

duration2 hoursCPD points3 points
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Clinical Trials Audit Preparation

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

duration1 hoursCPD points2 points
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GDPR Essentials for Pharmaceutical & Clinical Research Professionals

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

duration2 hoursCPD points3 points
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GCP for Medical Devices ISO 14155:2026

Learn the principles and requirements of ISO 14155:2026 for conducting compliant and ethical medical device clinical investigations.

duration2 hoursCPD points3 points
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Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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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

  • 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.