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This module will introduce you to the practical aspects of clinical trial ethics and regulations from a global perspective. You will learn how each of the topics covered, contribute to ensuring the safety, well-being, rights of participants and help preserve the scientific integrity of clinical trials, while also aligning with the UN Sustainable Development Goals (SDGs) for global health and development. This ensures that trials benefit the participants, society, and scientific knowledge, while also contributing to improving global health and reducing inequality.

This module will also introduce you to the important concept of having patient and public involvement (PPI) in all stages of a clinical trial, from the early stages of planning and design to the dissemination of results. PPI ensures that the perspectives of patients and members of the public are considered when making decisions about clinical trials, and that these trials are designed and conducted to address the needs and priorities of the people who will participate in them.

Each teaching week will focus on a specific topic relating to regulations and conduct:

1. ÌýEthical approval, informed consent & Good Clinical Practice (GCP)
2. Clinical Trial Regulations
3. Good Manufacturing Practice (GMP) for Investigational Medicinal Products (IMP)
4. Pharmacovigilance & Safety Monitoring
5. Patient & Public Involvement

By the end of this module, you will be able to:

• Identify and distinguish between appropriate and inappropriate trial conduct from ethical and regulatory perspectives.
• Explain good clinical practice and recommend appropriate courses of action to ensure good practice is set out and adhered to in given clinical trial situations.
• Evaluate good manufacturing and pharmacovigilance responsibilities for different types of IMP clinical trial and compose plans to manage those responsibilities.
• Apply the appropriate clinical trial regulations to different patient populations and interventions to ensure patient safety and data integrity.
• Recognise the value of patient and public involvement and be able to justify PPI in all stages of the clinical trials process from an idea through to communicating clinical trials results.

E6(R2) - Integrated Addendum to ICH Guideline for Good Clinical Practice’. Available at:

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