Leaders: French Clinical Research Infrastructure Network (F-CRIN), Hungarian Clinical Research Infrastructure Network (HECRIN), National Health and Medical Research Council (Australia)
To promote harmonised education, training and careers for investigators and clinical research professionals.
Description of the work:
Training for clinical research personnel such as data managers, clinical study monitors, regulatory and pharmacovigilance staff is often neglected. The few existing courses are isolated initiatives of some universities or medical schools, but all have their own focus. Therefore, there is a need to complete and harmonise training opportunities for such professionals.
Training of investigators is also highly variable across countries in terms of syllabi, training content and methods, and diplomas. Training requirements to participate as an investigator in a clinical trial are also highly divergent. Systems for ‘mutual recognition’ of investigator training may help to avoid duplication of training for a single investigator.
Finally, training of medical students on clinical trials is critical to prepare them as potential future investigators; training can help them to understand the value of interventional trials in supporting evidence-based medical practice, and to critically assess trial design and possible sources of bias.
In this context, this activity will entail various activities such as the definition of the required roles and skills for clinical research teams; a benchmarking of existing learning tools and initiatives for clinical research professionals; and the development of a single model of accreditation for the education and training of clinical research professionals.