Quality assurance CRU
The conducting of clinical scientific research is bound by legislation and regulations and Dutch legislature demands of researchers to meet a number of complicated requirements.
WMA statement of Helsinki
A clinical researcher is not only expected to be an expert in the field of research , but also to have an excellent knowledge of the latest legislation and regulations, international guidelines, as well as how to reach an agreement with key stakeholders, including medical centres, supporting departments and the pharmaceutical industry, in order to carry out the study.
The training of research staff is one of the key notes in clinical research. Subsequently, all clinical researchers have to complete the specific training called: Basis CursusRegelgeving en OrganisatieKlinischOnderzoekers (BROK-Course).