Читать книгу Randomised Clinical Trials - David Machin - Страница 125

There are internationally agreed standards under which clinical trials are conducted and these are encapsulated in GCP which is referenced as ICH E6 (R2) (2016). Then there are the more specific requirements, perhaps national as well as local, that must be adhered to. The precise details of these will vary with the trials’ geographical location, whether single or multicentre in design; local, national or international; the type of interventions under study, and the intended target participation groups.