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Guideline on GCP compliance in relation to trial ... - Europa
www.ema.europa.eu74 of the Clinical Trials Regulation EU) No 536/2014( (referred to as the Regulation“ ”) on clinical trials on 75 medicinal products, concerning the trial master file (TMF). According to recital 52 of the Regulation “ in 76 order to be able to demonstrate compliance with the protocol and with this Regulation, a clinical trial 77
Guideline on GCP compliance in relation to trial …
www.ema.europa.eu72 1. Executive summary 73 This guideline has been prepared to assist sponsors and investigators to comply wih the requirements t 74 of the Clinical Trials Regulation EU) No 536/2014( (referred to as the Regulation“ ”) on clinical trials on