ICH-GCP: Introduction to Good Clinical Practice


Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through ourย certificate online checker. They can also be shared on Linkedin.


Good clinical practice can be seen as a general framework ensuring that all stakeholders will be respected, listened to, taken into account, and accountable in the complex process of discovering new medical treatments, whether they be investigative drugs, improved treatments or medical devices. Compliance with GCP principles is required by regulatory authorities (FDA, EMA) in many countries for the authorization of clinical trials and the validation of their data.

This module introduces GCP. Our expert discusses the role and goals of the ICH (International Council for Harmonization) and the principles of GCP. Our expert describes the roles of members of a team working on a clinical trial. She sets out the documentation that must be written and validated. She defines the responsibilities of trial sponsors, clinical investigators and monitors. She explains the rationale and execution of the informed consent process, and discuss issues that arise in practice.




Lesson 1: Why do we need Good Clinical Practice ?ย 


Lesson 2: Concern about the safety of drugs


Lesson 3: Ethical Principles


Lesson 4: The four phases of Clinical Research


Lesson 5: International Council for Harmonization


Lesson 6: Principles of ICH GCP


Lesson 7: Code of Federal Regulations






patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She takes part in many startups boards.


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