Good Clinical Practice provides the internationally recognised ethical, scientific and quality framework for clinical trials involving human participants.
ICH GCP E6(R3) reflects the changing clinical research environment and provides a flexible, proportionate and risk-based approach to designing and conducting clinical trials. It places participant rights, safety and wellbeing at the centre of clinical research while supporting the generation of reliable and meaningful trial results.
Our comprehensive online GCP course explains the principles and requirements of E6(R3) and what they mean for people working across the clinical trial lifecycle.
The course covers informed consent, participant protection, sponsor and investigator responsibilities, clinical trial design, protocol compliance, quality management, monitoring, safety reporting, data governance, essential records and the appropriate use of technology.
You will also explore the increased emphasis within E6(R3) on quality by design, critical-to-quality factors, proportionate risk management, service-provider oversight and clinical trial processes that are appropriate for the risks and importance of the data being collected.
Rather than simply presenting the wording of the guideline, the course uses practical explanations, realistic clinical research examples, interactive content and knowledge checks to help you understand how GCP should be applied in practice.
The course is suitable as initial comprehensive GCP training and for experienced professionals who need to complete a full course based on E6(R3).
