GMP: GCP: EMA Draft Guideline relating to the Trial Master File


In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials. The draft has been adopted by the GCP Inspectors Working Group (GCP IWG). The public consultation period has started on April 12, the deadline for comments is July 11, 2017.