Preface: The evolution of Good Clinical Practice

The evolution of Good Clinical Practices (GCP) established by the International Council for Harmonisation (ICH) has marked a milestone in the development of clinical studies and ethics in research. Since the publication of the first version (E6(R1)) in 1996, the objective has been to promote the guarantee of protection of the rights, safety and well-being of participants in clinical studies and to improve the reliability of the data generated in them. GCP has been adapted to technological and scientific changes, as well as to the social and regulatory demands of research. 

The first revision, E6(R2), published in 2016, addressed the challenges associated with the advancement of technology in data collection and management, such as the use of electronic systems and quality risk management. This update was significant because it introduced a more dynamic approach to quality, promoting centralised monitoring and continuous risk assessment, allowing for greater flexibility in data management and improving efficiency in audit processes. In addition, it reinforced the need for clear policies on transparency and information security, adapting to the context of globalization of clinical studies and their execution in multiple countries and regions. 

The latest revision, E6(R3), published in 2025 represents a response to the demands of an ever-changing research environment, driven by advanced technologies, innovative quality designs, hybrid and decentralised clinical studies, and a patient-centred vision. This version strengthens the principles of ethics and scientific integrity and encourages an active participation of patients in research. It also incorporates a risk-based approach to quality, allowing for greater adaptability in the management and monitoring of clinical trials. 

How to use this course

This course has eight modules and each module should not take longer than 10-15 minutes to complete. You are not obliged to take the modules in order. 

At the end of each module, you will find an optional knowledge check quiz. You are not obliged to take these quizzes, and the score for these quizzes will not be counted towards your final assessment. You will find some additional knowledge check case study quizzes attached to each module, which may be useful to you or your team within a blended learning session.

Once you have completed module eight, you will be directed to a course feedback form. We will be grateful if this form can be filled out, so that we can continue to provide free eLearning resources to all learners. From the feedback form you will be directed to the final course quiz, and will be awarded your certificate upon scoring 80% or more. Your certificate will be saved on your profile page.