e-GCP Inspections Course (COMING SOON)

Our e-learning GCP inspection course is offered to representatives from National Regulatory Authorities (NRA) responsible for GCP inspections. We encourage you to to work through the most relevant documents. We take you on virtual tours of the clinical trial sites, where you can make direct observations. We make it possible for you to discuss with fellow participants and mentors the cases presented through various means (documents, presentations, videos and games). We designed this course to ultimately show you how the principles of the good clinical practice are applied in a variety of situations and how any possible deviations can be detected and concluded.

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

• explain the major principles of a good clinical research practice
• match 14 GCP principles and their implications
• complete a preparation for a GCP inspection
• describe the important steps to effectively communicate with the trial site before, during and after an inspection
• investigate the different situations, and define deviations from the study protocol and GCP principles
• produce a report concluding the mode of action for given situations.