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Informed Consent in Clinical Research Course & Certification
Intermediate
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4.7
★★★★★
96% Recommended
Updated 2026
2 hour
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Each course includes:
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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
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About
The Informed Consent in Clinical Research Course is designed to provide a clear understanding of the ethical and regulatory principles governing informed consent in clinical trials. The course focuses on ensuring that participants are fully informed, voluntarily agree to participate, and understand their rights throughout the research process.
This course covers the informed consent process, ethical principles, regulatory requirements, consent form development, communication strategies, documentation practices, and re-consent procedures. It also emphasizes Good Clinical Practice (GCP) guidelines, participant protection, and audit readiness. Upon successful completion, learners receive a certification demonstrating competency in informed consent in clinical research.
Who Should Enrol?
- Clinical Research Professionals
- Clinical Trial Managers and Coordinators
- Clinical Research Associates (CRAs)
- Principal Investigators and Sub-Investigators
- Regulatory Affairs and Compliance Professionals
- Pharmacovigilance and Clinical Operations Teams
- Ethics Committee Members
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of informed consent in clinical research, including its ethical basis, key elements, and responsibilities of research teams.
Learn the complete informed consent process, from preparation and discussion to comprehension assessment, documentation, and ongoing consent management.
Gain knowledge of informed consent forms (ICF) and participant information sheets (PIS), including design, readability, version control, amendments, and special population considerations.
Develop an understanding of advanced consent scenarios, including eConsent, re-consent, withdrawal processes, and challenges such as vulnerability, literacy barriers, and therapeutic misconception.
Course Syllabus
- The Meaning of Informed Consent
- The Ethical Foundations
- The Five Elements of Valid Consent
- Who Is Responsible?
- Preparation and Planning
- The Consent Discussion
- Assessing Comprehension
- Obtaining & Documenting Consent
- Ongoing Consent Management
- What is eConsent?
- Technology, Platforms & Validation
- Remote Consent—Challenges & Safeguards
- Data Privacy & GDPR in eConsent
- Decentralised Clinical Trials & Consent
- What Is the ICF?
- ICF Design & Readability
- ICF Version Control & Amendments
- The Participant Information Sheet (PIS)
- Special Populations & Adapted ICFs
- What Is Re-Consent?
- Triggers for Re-Consent
- The Re-Consent Process
- Documentation & Record-Keeping
- Special Situations in Re-Consent
- The Right to Withdraw
- Managing Voluntary Withdrawal
- Data After Withdrawal
- Investigator-Initiated Withdrawal
- Documentation & Audit-Readiness
- Therapeutic Misconception
- Literacy & Language Barriers
- Capacity & Vulnerability
- Coercion & Undue Influence
- Emergency Consent Situations
- 📘 Bonus: Informed Consent in Clinical Research eBook (Free with purchase)
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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
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