Archiving – How long?
EMA/15975/2016 (“Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of …
Category: GxP-Compliance
Trial Management – Lost in delegation?
Clinical trials call upon a complex network of resources i.e. parties contracted by the sponsor and parties subcontracted by such delegates (e.g. …