The Faculty of social and behavioural sciences, health-medical section and Neuropsychology (GMN) of Leiden University is working hard to set a quality standard for their research. GCP Central was invited to give a WMO / GCP training.
Behavioral sciences research has different dilemmas than other WMO-related research. When researching lifestyle interventions in patients with chronic illness, the effects of cognitive behavioral therapy and the effect of stress on rheumatoid arthritis, what do you consider dilemmas? The trainees indicate that they always have to weigh up whether an investigation is mandatory or not WMO. Because when is a questionnaire study WMO obligatory? Is a study with healthy people about the impact of stress a medical scientific research? These and similar cases led to interesting discussions.
It is clear that WMO / GCP rules apply just as well here, but the application and context are different. In the training we have therefore placed more focus on documentation, submission and responsibilities than on reporting side effects. In addition, we spoke about the sectionGMNestablished research procedures based on the GCP guidelines. The procedures are a good basis for high-quality research that is set up and carried out in this department. By researchers who are now nationally WMO / GCP certified.