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About

The GCP – Informed Consent in Clinical Research Training Course by Whitehall Training is designed to provide a comprehensive understanding of the informed consent process, a fundamental requirement in ethical clinical research. Suitable for investigators, study coordinators, and research professionals, this course builds a strong foundation in participant rights, regulatory expectations, and ethical conduct. You will explore key topics such as the principles of informed consent, documentation requirements, communication with participants, and special considerations for vulnerable populations. Through practical examples and real-world scenarios, you’ll learn how to obtain, document, and manage informed consent in compliance with ICH-GCP and global regulatory standards.

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 Meaning of Informed Consent
  2. The Ethical Foundations
  3. The Five Elements of Valid Consent
  4. Who Is Responsible?

  1. Preparation and Planning
  2. The Consent Discussion
  3. Assessing Comprehension
  4. Obtaining & Documenting Consent
  5. Ongoing Consent Management

  1. What is eConsent?
  2. Technology, Platforms & Validation
  3. Remote Consent—Challenges & Safeguards
  4. Data Privacy & GDPR in eConsent
  5. Decentralised Clinical Trials & Consent

  1. What Is the ICF?
  2. ICF Design & Readability
  3. ICF Version Control & Amendments
  4. The Participant Information Sheet (PIS)
  5. Special Populations & Adapted ICFs

  1. What Is Re-Consent?
  2. Triggers for Re-Consent
  3. The Re-Consent Process
  4. Documentation & Record-Keeping
  5. Special Situations in Re-Consent

  1. The Right to Withdraw
  2. Managing Voluntary Withdrawal
  3. Data After Withdrawal
  4. Investigator-Initiated Withdrawal
  5. Documentation & Audit-Readiness

  1. Therapeutic Misconception
  2. Literacy & Language Barriers
  3. Capacity & Vulnerability
  4. Coercion & Undue Influence
  5. Emergency Consent Situations

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

The GCP – Informed Consent in Clinical Research Training Course by Whitehall Training is designed to provide a comprehensive understanding of the informed consent process, a fundamental requirement in ethical clinical research. Suitable for investigators, study coordinators, and research professionals, this course builds a strong foundation in participant rights, regulatory expectations, and ethical conduct.

You will explore key topics such as the principles of informed consent, documentation requirements, communication with participants, and special considerations for vulnerable populations. Through practical examples and real-world scenarios, you’ll learn how to obtain, document, and manage informed consent in compliance with ICH-GCP and global regulatory standards.

This course is ideal for individuals who want to begin or advance a career in clinical research, including:

  • Principal Investigators and Sub-Investigators
  • Clinical Research Coordinators and Study Nurses
  • Clinical Research Associates (CRAs)
  • Ethics Committee / IRB Members
  • Regulatory Affairs Professionals
  • Clinical Trial Assistants and Site Staff
  • Healthcare professionals involved in clinical research
  • Anyone seeking a better understanding of informed consent and GCP requirements.

  • Industry-aligned training course with global recognition
  • Fully updated to ICH GCP E6 (R3) requirements
  • Apply best practices in clinical trials
  • Practical, scenario-based learning to build real-world confidence
  • Certificate issued upon successful completion