A 2-day certification course covering trial design, project management, self audit and developing GCP problem solving skills.
This is an advanced course ideal for those who have already attended the Fundamentals course or have experience in the clinical trial process. The course involves a large amount of group work.
At the end of the course participants should be able to develop a study concept into a clinical trial and use critical path analysis to plan timescales and resources. Participants should be able to resolve GCP-related problems and have a good awareness of the procedures and processes required to set up an interventional trial in Europe involving medicinal products in humans. Participants will also have awareness of other regulations affecting clinical trials including some US requirements
Using learning by involvement techniques, participants will
develop GCP problem solving skills by considering the most common problems encountered in clinical trials, how to solve them and how to prevent recurrence
develop project design and management skills. Participants take part in a practical workshop on study design, determining study timescales and logistics, project planning and management. Each group project is presented for critique
consider ways to improve the recruitment of subjects to clinical trials
develop self-audit/monitoring skills using a mock audit exercise to examine deficiencies in clinical trial documentation (including the signs of research fraud).
Presentations will
provide an update of the latest development in clinical research (eg. ICH process and products, new topics, changes to regulations, EU Directives and guidelines including an executive overview of the scope, content and consequences of EU clinical trials Directive 2001/20/EC and GCP Directive 2005/28/EC
summarise at a high level, the processes involved in setting up and completing a trial in Europe (requirements of the latest EU Directives and Detailed Guidance)
consider other Regulations, Directives and guidelines affecting clinical trials including: data protection, using computerised systems in clinical trials and some US requirements affecting trials in Europe such as financial disclosure.