This 1-day course is a plain language guide to product
development, clinical trial methodology and terminology and essentials of GCP.
No prior knowledge or experience is required.
This course is ideal for new personnel, those in non-technical roles requiring
basic knowledge of clinical trials and GCP responsibilities, administrators,
members of non-clinical departments in commercial companies and members of
ethics committees. The course is the first day of our Fundamentals of Clinical
research course.
At the end of the course participants should have a good understanding of the clinical trial process, be aware of the need to comply with GCP and be aware of the most important GCP responsibilities. The course will inform participants about
the development of a new medicinal product through the various phases of clinical research
the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use; Phases I to IV and PMS)
abbreviations, methodology and terminology in a plain understandable language including study designs (parallel group/crossover), blinding methods, use of placebo and other controls
good clinical practice (GCP) and its implementation by standard operating procedures
the ICH process and its products
the processes involved in setting up a clinical trial from planning to final report including GCP requirements at each stage.